Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy

Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy Sophie M. C. Green, David P. French, Christopher D. Graham, Louise H. Hall, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1239166/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 8 You are reading this latest preprint version Abstract Background Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). Methods Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. Results The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 2 4−1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components and overall trial experience. Conclusions We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions. breast cancer medication adherence intervention mapping multiphase optimisation strategy Figures Figure 1 Figure 2 Figure 3 Background Breast cancer is the most common cause of cancer death in women ( 1 ). Around 75% of breast cancers are oestrogen receptor-positive (ER+)( 2 ). Adjuvant endocrine therapy (AET), including tamoxifen and aromatase inhibitors (AIs; anastrozole, letrozole, exemestane) are prescribed to women with ER+ breast cancer to reduce the risk of cancer recurrence and mortality ( 3 , 4 ). AET is prescribed for 5-10 years ( 5 ), with 7-8 years potentially the optimal duration ( 6 – 9 ). However, up to three-quarters of patients do not take AET as prescribed ( 10 – 13 ). Non-adherence and non-persistence (not continuing to take the medication for the prescribed duration) are linked to an increased risk of recurrence, lower survival and reduced quality-adjusted life years ( 14 – 16 ). Improving adherence to AET could reduce healthcare costs associated with cancer recurrence ( 15 ). Modifiable barriers to AET adherence have been identified ( 17 – 20 ). Most existing interventions do not target multiple factors associated with adherence, and predominantly consist of solely educational interventions, such as leaflets ( 21 – 23 ). Such interventions have either been ineffective or yield small effect sizes ( 21 – 23 ). This is characteristic of interventions aiming to support adherence across a wide range of chronic conditions, highlighting the need for improved interventions to support adherence more generally ( 24 ). Considerations of theory in interventions aiming to support AET adherence are often lacking, with little transparency of the intervention development process. The UK Medical Research Council Framework (MRC) for developing and evaluating complex interventions, and INDEX guidance (Identifying and assessing different approaches to developing complex interventions) suggest interventions should consider theory in a systematic manner to aid replication and implementation ( 25 – 27 ). Intervention mapping (IM) is a systematic approach used to develop theory and evidence-based health interventions. It consists of six stages that cover designing, implementing and evaluating an intervention ( 28 ). The AET adherence trials published to date are mostly evaluated using parallel groups randomised controlled trials (RCTs). RCTs can definitively evaluate whether an intervention package as a whole has a statistically significant effect compared with a comparator. However, RCTs alone are unable to explain which components of a complex intervention affect the outcome, whether there are interactions between intervention components, and whether the benefits of an intervention component are justified based on resource demands. The Multiphase Optimisation Strategy (MOST) addresses these limitations ( 29 ) by optimising interventions based on the performance of individual intervention components relative to resource constraints. MOST consists of three phases: ( 1 ) preparation, in which intervention components are developed; ( 2 ) optimisation, in which efficient experimental designs, which estimate main effects and interactions between intervention components, are used to build an optimal intervention package; and ( 3 ) evaluation, in which the optimised intervention package is evaluated, typically using a parallel groups RCT. There are important factors to consider when developing interventions within the MOST framework. These include ensuring each intervention component targets a specific mediating variable, that there is minimal overlap between the content of the intervention components, and that thought is given to the challenges of delivering all intervention components within a single package ( 30 ). Combining the IM and MOST frameworks enables these considerations of MOST to be acknowledged systematically throughout every stage of development within IM. This paper describes the development of an intervention package to support AET adherence in women with early-stage breast cancer, aiming to provide an exemplar of how to incorporate IM into the MOST framework. Methods We progressed through six stages of IM in line with published guidance (Table 1 ) ( 28 ). We followed the Guidance for reporting intervention development studies in health research (GUIDED) ( 31 ). [Table 1 ] Stage 1: Needs assessment The needs assessment involved three sub-stages: ( 1 ) a literature review to understand the extent of non-adherence in women prescribed AET; ( 2 ) a literature review to understand the barriers to AET adherence, predominantly focusing on existing reviews identified through backward citation searching ( 11 , 18 , 20 , 32 – 40 ); and ( 3 ) a rapid review and search of trial registries to identify published interventions and ongoing trials addressing AET adherence. The terms “hormone therapy” “breast cancer”, “adherence”, “intervention” and their variations were used. One author (SG) screened the texts and extracted data. The needs assessment informed the primary aims of the intervention package. Stage 2: Intervention Objectives Modifiable determinants of AET adherence to be targeted in the intervention package were selected based on the results of stage 1. For each determinant chosen, specific objectives for an intervention component to target were defined. Stage 2 considered how IM could be incorporated into MOST. An important aspect of the preparation phase of MOST is the conceptual model ( 30 ), similar to the logic model produced in IM. A conceptual model details how each intervention component is expected to change the outcome. It is recommended that each intervention component targets one specific mediating variable to aid decision making within the optimisation phase ( 41 ). The intervention components should be reasonably independent to ensure one component does not depend on the presence of another. This means that participants’ experiences of a component should not be affected by which of the other components they may receive ( 30 ). Conceptual model development was iterative; draft illustrations of the model were created, discussed within the research team, and with Patient and Public Involvement (PPI) members. Stage 3: Intervention design For each determinant of AET adherence that we identified and selected in stages 1 and 2, existing interventions and associated literature were explored to identify suitable theories, evidence-based behaviour change methods and practical strategies that could address them. The research team, in collaboration with PPI members, used this evidence to discuss which strategies were most likely to be effective and implementable within the UK healthcare system. Stage 4: Intervention Development Four intervention components were developed; two new components and two adapted from existing interventions. Clinician, researcher and patient views were considered throughout. To aid future replication, the intervention components were coded onto the Behaviour Change Techniques taxonomy (BCTTv1) by one author (SG) who had completed BCTTv1 training ( 42 ). Component coding was discussed between members of the research team (SG, SS, CG, LH). Disagreements were discussed and resolved. A Flesch-Kincaid reading age and grade level was calculated for each component ( 43 ). Stage 5: Implementation planning Implementation factors such as cost, time and delivery method were considered. A criterion by which the intervention will be optimised was specified, as recommended by the MOST framework. The optimisation criterion operationalises the primary outcome, and key considerations that the optimised intervention should fit within, such as effectiveness, cost and time ( 44 ). Stage 6: Evaluation plan We planned how the intervention components will be optimised and evaluated. The research team, in collaboration with PPI members and stakeholders selected the outcome measures to be used for assessment, the evaluation design, and the process evaluation research questions. A protocol for a pilot trial to assess the feasibility of an optimisation trial was prepared. We specified expected interactions between intervention components, based on theoretical assumptions identified in Stage 3. The a priori specification of hypothesised interactions is important, as components forming the interactions will be prioritised when deciding the optimised intervention package ( 45 ). Patient and Public Involvement (PPI) Our PPI panel of five members met remotely with two researchers (SG, ER) every 2-3 months throughout the development phase. The panel comprised five women with a diagnosis of breast cancer and experience of taking AET, recruited by advertising through a charity supporting people affected by cancer. Members were compensated for their time. Results Stage 1: Needs assessment (findings from literature reviews) Extent of nonadherence Adherence to AET is suboptimal, with up to 73% not taking it as prescribed (11, 36). A large number of women discontinue AET within the first year (46). Adherence diminishes over time, with up to 50% of women being non-adherent within five years (10, 13). Unintentional nonadherence (e.g. forgetting to take medication) may be more prevalent than intentional nonadherence (e.g. deciding to miss a tablet) (47-49). Factors associated with adherence and nonadherence Barriers to and facilitators of AET adherence were identified (Table 2). Side-effects The frequency, severity and inability to manage side-effects are common barriers to AET adherence and persistence (11, 18, 20, 34, 37-40, 57). However, some reviews have questioned this relationship, citing inconsistent evidence (32, 37). Qualitative studies highlight reasons for non-adherence including the impact of side-effects on quality of life (58), side-effects outweighing the benefits (53, 58), a lack of understandable information about the range and intensity of side-effects (53, 56), and women feeling unsupported in managing side-effects (50, 53, 58). There is a clear demand for information about side-effects and their management (59). Medication beliefs and illness perceptions Necessity beliefs and concerns about AET, and the cost-benefit balance between these are associated with reduced adherence (11, 18-20, 32, 34-36, 38, 40). For example, adherent women tend to report strong necessity beliefs, such as “Tamoxifen is keeping me alive”, AET helps them to feel in control, and that AET will enable them to stay alive for their family (56, 58). In contrast, less adherent women report more concerns, such as AET benefits not being worth the reduced quality of life, and worry about the chance of cancer elsewhere (58). Representations of breast cancer, such as believing the likelihood of recurrence is low, are also associated with lower adherence (51, 52). Knowledge of medication Lower knowledge about AET is associated with reduced adherence (34). Women consistently report receiving insufficient information about AET (50, 58). Approximately one fifth of breast cancer survivors in a Dutch survey did not know how AET worked, but wanted further information, and a third did not know how large the risk reduction effect was (48). Psychological distress Immediatley following active treatment, approximately half of women with breast cancer report higher levels of psychological distress than observed in the general population (20, 60, 61). Psychological distress in breast cancer can include rumination and worry about breast cancer recurrence, difficulties in returning to ‘normal’, and distress from AET side effects (53, 58, 59). Higher levels of distress are associated with lower adherence (20, 55), although some inconsistencies with this relationship have been observed (37, 62). Forgetfulness Women with breast cancer commonly report memory problems following chemotherapy, which can increase forgetfulness and consequently unintentional nonadherence (18, 32, 36, 56, 63-65). Social support Women often feel abandoned when ending active treatment and being discharged from care (66). Higher social support from family, friends and other breast cancer survivors are associated with improved adherence and persistence (11, 32, 34, 35, 37, 38, 52, 67). Self-efficacy Self-efficacy is associated with higher adherence (32, 34, 38). This includes self-efficacy in the patient-physician interaction (confidence in the ability to get medical information from a physician (34, 38, 68)), and perceived self-efficacy in relation to learning about and taking AET (32, 34, 38). Patient-physician communication Patient-reported positive relationships with physicians are associated with higher adherence (20, 32, 35, 37, 38), specifically, the quality and person-centeredness of the relationship, frequency of communication, and sufficiency of information received about AET (38). Existing interventions supporting adherence We identified 16 published trials evaluating interventions targeting adherence to AET (Table 3) and 15 ongoing trials (Table 4). There was little high-quality evidence that these interventions were effective. Of the 16 published interventions, six reported statistically significant improvement in adherence. Two of those with significant findings were pilot trials and therefore were not designed to examine efficacy, two found significant findings in post-hoc analyses, and for one, a significant effect was not maintained at follow up. Six published trials composed only of educational materials which were not effective in supporting adherence (69-74). Digital health interventions appeared to be increasingly prevalent. Four existing interventions (75-78), and three registered trials involved text messaging either solely or as part of a multi-component intervention. Two published interventions (75, 78) and five registered trials included an app or website. One registered trial is using videoconferencing. Of the four published digital interventions, three assessed and reported acceptability to patients (75, 77, 78). The theoretical basis and development process were inadequately described for most published interventions. [Table 3 and 4] Intervention Goals The needs assessment established the overall goal of the programme; to improve AET adherence in women with early-stage breast cancer, using a multi-component intervention. All barriers to AET adherence identified in Stage 1 were considered in Stage 2. Stage 2: Intervention Objectives Based on findings from Stage 1, and following discussion within the research team and agreement from patient representatives, four main intervention targets were selected; living with side effects, medication and illness beliefs, forgetfulness and psychological distress. These cover a range of intentional and unintentional barriers to adherence. Table 5 summarises identified determinants and the specific intervention component objectives. Illness perceptions and knowledge can affect medication beliefs through providing an understanding of how the medication works, which can enhance beliefs about its necessity (86, 87). We therefore targeted knowledge in combination with medication beliefs. Three determinants were not chosen as mediating variables within the conceptual model: social support; self-efficacy; and patient-physician communication. These factors are likely to be addressed by the intervention components already chosen. For example, support from a psychological therapist as part of one of the proposed components has the potential to reduce feelings of abandonment, thus targeting one aspect of social support. The selection of determinants based on the needs assessment, informed the conceptual model. A conceptual model, as recommended by the MRC framework, can provide a visual representation of the theoretical basis of the intervention and can improve generalisability and replicability of the intervention (26). The development of a conceptual model is a key part of the preparation phase of MOST, in which separate intervention component targets are specified (30). Stages 1 and 2 of IM informed the intervention target, pathway and outcome aspects of the model (Figure 1). Stages 3 and 4 of IM provide detail on the individual intervention components. For two determinants (forgetfulness and psychological distress), there are additional stages in the conceptual model to demonstrate the pathway to adherence, described in detail in Stage 3. Figure 1. Conceptual Model Stage 3: Intervention design Within factorial designs commonly used within the MOST framework, each component must be distinct, with minimal duplication of content across components (30, 41). This was considered in Stages 3 and 4. Taking the four main intervention component targets in Stage 2 (memory, illness and medication beliefs, psychological distress, side-effects), Stage 3 focused on identifying theory-based change methods and practical strategies to target these mediators. Forgetfulness If medication taking becomes habitual and less reliant on memory, unintentional nonadherence may reduce (88-92). Habit theory stipulates there are multiple phases in forming a habit; deciding to act, acting on that decision, and doing so repeatedly in a manner conducive to development of behaviour cue associations (89, 92, 93). Table 5 details behaviour change techniques (BCTs) related to habit formation that were feasible to target (92, 94-96). Mobile messaging interventions are increasingly used to promote adherence to medications, and could be cost-effective for promoting habit formation (97-99). Meta-analyses and systematic reviews have highlighted the significant positive effects SMS interventions could have upon medication adherence in long-term conditions, although none included women with breast cancer (97, 100). Individual studies of SMS interventions to promote adherence by women with breast cancer have shown mixed results (76-78). These interventions did not target habit formation specifically, and often repeated the same messages, which could cause response fatigue (97, 98, 101). Medication and illness beliefs Information provision can support the formation of medication beliefs (102, 103). The Necessity-Concerns framework suggests patients weigh up the benefits and costs when considering a medication (104). An extended version of the commonsense model of illness representations (CSM) highlights that cognitive and emotional illness representations, in addition to medication beliefs, influence adherence (105). Illness representations have been correlated with necessity and concern beliefs in women with AET (54), suggesting they could be targeted together. Providing positively framed and accurate written information about the benefits and risks of AET could increase necessity beliefs and reduce unhelpful concerns and illness representations (86, 87, 103, 106-108). Psychological distress Within a range of long-term conditions including cancer, Acceptance and Commitment Therapy (ACT) can reduce psychological distress (109, 110) and improve functioning and quality of life (109-115). ACT is a newer type of cognitive behavioural therapy, that aims to help people engage in activity they find enriching and meaningful, even in objectively difficult situations (for example being diagnosed with cancer), by engendering a quality called psychological flexibility (116). Psychological flexibility involves individuals approaching experiences with openness and awareness to engage more fully with their own overarching goals and values (116). Psychological inflexibility is associated with psychological distress in breast cancer survivors (117). Preliminary studies show psychological flexibility is positively correlated with treatment uptake and adherence in long term conditions, and that ACT could be helpful for improving medication adherence (109, 118-121). ACT could improve overall wellbeing and reduce psychological distress by enabling individuals to function effectively alongside common emotional experiences that occur in this population (66). Living with side-effects Many side-effects women experience while taking AET can be managed without speaking to a healthcare professional (122). Many women taking AET already self-manage their symptoms, and most want more support to do this (123). In previous co-development work, patient representatives and healthcare professionals suggested that a website would allow patients to access side-effect management resources when required (66). Demand for an online resource detailing evidence-based solutions to manage side-effects has also been reported elsewhere (124). As a result of Stage 3, the practical strategies to target each determinant were confirmed, to be developed in Stage 4. Stage 4: Intervention Development Four intervention components were developed using distinct formats: SMS messages, an information leaflet, ACT sessions, and a side-effect management website (Additional file 1). The same considerations with regard to MOST were applied here as in Stage 3 in attempting to develop standalone components distinct from one another (30). As a result, the four intervention components largely targeted a range of separate BCTs, with some minimal overlap (Figure 2, Table 5). Readability of the components ranged between 11 and 14 years old (Table 6). The 12-item ‘Template for Intervention Description and Replication’ (TIDieR) checklist describes the intervention components (125) (Additional file 2). [Table 5] Figure 2. Behaviour change techniques present in intervention components SMS Development SMS messages were co-developed using an established method for producing acceptable messages with high fidelity to the intended BCT (126). This method has previously produced SMS messages that maintained acceptability and fidelity to intended BCTs when sent within a feasibility trial (127), and were successful in changing hypothesised mediating variables (128). For our intervention component, behaviour change experts created messages based on BCTs during a one-day workshop, and rated the BCTs on relevance to adherence and the fidelity of individual messages to the BCT they intended to target. These messages were revised following a focus group with PPI members, and rated on acceptability by breast cancer survivors. An additional group of behaviour change experts rated message fidelity to the BCT. The SMS intervention component will begin with two weeks of daily messages, as habit formation occurs most rapidly within the first two weeks (93, 129). The messages will reduce to twice weekly for 8 weeks to ensure they do not become intrusive. One of the main reasons for nonadherence in an SMS trial was cited as forgetting at weekends due to a change of routine (77, 130). Messages sent twice weekly can support medication taking in the change of routine at weekends. The SMS messages will then reduce to weekly reminders for 6 weeks, as medication taking should become sufficiently habitual to persist despite a reduction in support. Frequent messages over a long period could lead to response fatigue; weekly messages are less susceptible to this effect (97, 98, 101). It is important to reduce the frequency so that habit formation is not dependent on reminders, but is due to creating cues for medication taking (94). To target all phases of habit formation concurrently, a combination of BCTs will be targeted throughout (92). Information Leaflet Development The development of the information leaflet was an iterative process. It contains five elements (Table 5). PPI members were involved throughout, including planning the content, critiquing drafts, and confirming the content of the final version. Content was informed by information from reputable sources (e.g. NHS website, MacMillan and Cancer research UK). A professional design company was commissioned to create the leaflet. Design decisions, including font size, colour contrasts and layout were informed by the Medicines and Healthcare products Regulatory Agency (MHRA) best practice for information design (131). The leaflet underwent further refinement via patient feedback within PPI meetings, and clinical input from a consultant pharmacist. Acceptance and Commitment Therapy (ACT) Development The ACT component was developed from an existing guided self-help intervention for improving quality of life and distress in people with muscle disorders (132). The programme, which includes common ACT techniques (133), was adapted to be relevant to women with breast cancer taking AET. It was adapted by two clinical psychologists (CG and JC) with experience in ACT and breast cancer, in collaboration with members of the research team (SS and SG). PPI members provided feedback at the planning and drafting stages. The adaptation involved rewording the participant module booklets to be relevant for women taking AET, and providing additional exercises to foster self-compassion. The resulting intervention component involves guided self-help, consisting of four distinct modules (Table 5). Module content is presented in four participant handbooks supplemented by audio files and home practice tasks, which are conceptualised to participants as enabling them to develop four specific skills related to psychological flexibility (Table 5). The four modules are supported by five individual sessions with a practitioner psychologist ranging from 15-25 minutes. The sessions provide a space to discuss the module content, to reflect on experience of practising the skills in everyday life, and to consider their helpfulness. Website Development The side-effect management website was developed as part of an existing intervention for women taking AET (66). The content of the website was informed by an umbrella review of self-management strategies for side-effects in AET (122) and suggestions from breast cancer survivors. Suggestions included the use of patient narratives (66), which have been shown to improve engagement (134, 135). To adapt the intervention, design elements were changed, and some sections were removed to ensure this was a standalone component only targeting side-effects (30). Stage 5: Implementation planning The optimisation criterion was based on health economic modelling (15). An intervention that is effective at showing an absolute improvement of 10% in adherence would be considered cost effective if it could be delivered for less than £3997 per patient. The optimisation criterion will be considered in the optimisation phase to ensure the intervention package developed is likely to be within cost-effectiveness thresholds. Discussions with stakeholders highlighted the following considerations for potential implementation and maintenance of the intervention components. The SMS, information leaflet, and website components all represent relatively low-cost components with relatively modest maintenance needs. Therapist hours, cost and mode of delivery were considered in detail for the ACT component. There was a large amount of stakeholder engagement throughout the ACT adaptation process, involving patient representatives, clinical psychologists and service managers to consider feasibility of implementation within the NHS (66). A guided self-help intervention was chosen by the research team in collaboration with patient representatives, as it required a lower number of therapist hours to deliver. This follows a similar approach to the Improving Access to Psychological Therapies (IAPT) model, which uses brief guided self-help interventions and has been widely implemented in the NHS (136). Remote delivery was chosen as it can benefit patients through eliminating the need to travel to sessions. Remote delivery also reduces the need to identify clinic rooms which can be a constraint in NHS psychological services. The option of telephone or videoconferencing was chosen to reduce exclusion of those without access to videoconferencing software or a private space. Guidance for how to use videoconferencing platforms will be given. Stage 6: Evaluation plan Specification of plans for evaluation design We prepared a protocol for an external exploratory pilot trial using a 2 4-1 fractional factorial design to determine the acceptability of the intervention components, and the feasibility of evaluating them in a larger optimisation trial (41, 137). Our evaluation plans specified an optimisation trial using a 2 4 factorial design, if the criteria for progression from pilot to optimisation trial are met. Process evaluation questions Our evaluation plans specified we will conduct a nested process evaluation using a mixed methods approach to evaluate the acceptability of the intervention components and experimental design, assess the fidelity of the intervention components (138), and to assess trial experience and recruitment barriers. These aims will address uncertainties regarding the feasibility of delivering a complex experimental design in a clinical setting largely familiar with more classical methods for intervention evaluation. Development of indicators and measures for assessment Outcome measures were chosen through discussion within the research team, and consensus from the Trial Management Group and Trial Steering Committee (Figure 3). To allow for analyses of mechanisms of action, assessment measures were included for all hypothesised mediators identified. Figure 3. Summary of Assessment Measures Completion of the evaluation plan The external exploratory pilot trial (ISRCTN: 10487576) is ongoing. Expected interactions between intervention components Hypothesised synergistic interactions are displayed using dashed lines in Figure 1 and explained below. No antagonistic interactions were hypothesised. SMS Messages and Information Leaflet Habit formation consists of multiple phases (89, 92, 93). SMS reminders will specifically target initiation, and repetition conducive to formation of cue-behaviour associations. The other phase, deciding to take the medication, relies on motivation to engage in the behaviour (92), which could be influenced by a positive necessity-concerns differential (139). Therefore, we hypothesise the information leaflet will contribute to and enhance the process of habit formation, resulting in a greater overall effect on adherence. ACT and Information Leaflet Some processes in ACT will indirectly target emotional representations of illness, that are associated with medication beliefs (32). For example, ACT-based skills that help one ‘unhook’ from distressing thoughts, could positively affect emotional representations, such as reducing fear of recurrence (140). Reducing emotional representations such as worry may synergistically reduce concerns about AET (54). Therefore, ACT and the information leaflet together may have a greater effect on medication adherence than each component alone. Website and Information Leaflet A major concern women have with AET is side-effects (50, 56, 58, 141). From a causal learning theory perspective to adherence, bottom-up learning (where actual experiences shape beliefs) may occur in which experiences with side-effects could shape medication beliefs (102). The website may have a positive effect on experience of side-effects, while the information leaflet may reduce concerns, leading to a more positive necessity-concerns differential (139). Consequently, combining the website and information leaflet may have an overall greater impact on adherence. ACT and Website Engagement in ACT techniques may increase willingness to tolerate side-effects when medication-taking is consistent with values, and can reduce symptom interference (111, 115, 116, 142). Engagement in the ACT component in combination with self-management strategies from the website, may therefore increase one’s ability to live well alongside side-effects, reducing their interference with meaningful functioning, consequently leading to greater adherence. Additionally, use of the website may reduce side-effects. If the impact of side-effects is reduced, participants may be able to focus on life-enriching activities consistent with their values (116, 121, 142). Therefore, use of the website may enhance engagement in the ACT component, leading to a greater overall effect upon adherence. Discussion We have demonstrated a transparent and systematic approach to the development of a complex behavioural intervention designed to support medication adherence in women with breast cancer. Using an iterative IM approach, and informed by the MOST framework, we used existing evidence, behavioural science theory, and patient experience to design an intervention package consisting of four intervention components (SMS, information leaflet, ACT, website) targeting key determinants of AET adherence. Our study illustrates how intervention development can be guided by both IM and the MOST framework ( 29 , 30 , 41 ). Our plans to use a factorial design to optimise the intervention package will help delineate the individual contributions and interactions between the intervention components. This optimisation process aims to develop interventions that are more effective, efficient and scalable ( 29 , 41 , 143 ). This approach could accelerate knowledge in intervention development through improved understanding of which aspects of an intervention work and why ( 144 ). Combining IM with MOST could therefore be a more efficient method to develop and evaluate interventions, than using IM alone. The MOST framework influenced key points in the intervention development process, namely, ensuring each component targeted a specific mediator, consideration of how the intervention components fit together as a package, and ensuring each component was distinct. Using a staged approach such as IM enabled us to consider these points throughout development. To avoid the possibility of developing a disjointed intervention package we ensured continuity in the aesthestics of each component. The difficulty in targeting all barriers to adherence identified in the needs assessment was a challenge. For example, in terms of social support, while the developed ACT component does provide a degree of social support, it could be argued that this could be more adequately addressed with a group-based psychotherapy intervention. However, evaluating group-based intervention components using a factorial experiment would necessitate more complex, multilevel designs ( 145 ). While such designs exist, they are rarely used and methodological expertise and guidance are lacking. This led to uncertainty in deciding between a group-based or an individual psychotherapy component. Should we receive strong feedback from women receiving these interventions within the planned pilot trial that they would have preferred a group-based approach, we will give further consideration to evaluating it in a future optimisation trial. This decision will be guided by the results of a separate pilot trial of a group-based ACT intervention currently being undertaken by the authors (LH, SS, CG, JC) ( 146 ). A further challenge of our approach was related to coding the active ingredients of the isolated intervention components. We felt it was important to use the same taxonomy to allow comparisons across intervention components. Therefore, we chose the BCTTv1 as this was the most widely used approach for coding behavioural interventions ( 42 ). However, the taxonomy was more challenging to apply to the ACT component than others, and several ACT specific intervention methods could not be positioned in the BCTTv1. This highlighted that the BCTTv1 taxonomy does not comprehensively cover all techniques that are involved in ACT based interventions; a limitation also acknowledged elsewhere ( 147 ). Using factorial trials to evaluate multiple intervention components, as suggested by the MOST framework, is a relatively new approach in health services research. We made adaptations to IM based on time available and to include important considerations guided by MOST ( 28 , 148 ). Strengths of our approach include applying an established intervention development method within the MOST framework, and the systematic reporting of the intervention development process. The differing formats of the intervention components allowed each determinant to be targeted using the most appropriate modality for that determinant. However, evaluating different formats of components may confound the mechanism of the intervention with the content. For example, participants may find the ACT component more engaging due to interaction with a therapist, rather than due to the content of the component. Future work could consider whether there is an intervention format that would be appropriate for all determinants to reduce disparity between components. Conclusions We have developed a complex behavioural intervention package, made up of four intervention components, to support women with breast cancer in taking AET. We have also demonstrated how IM can be harnessed to develop an intervention package that targets known determinants of medication taking behaviour in this population. Guided by MOST, this intervention package will be optimised in further trials with the aim of defining effective, efficient and scalable strategies to support behaviour change. Declarations Ethics approval and consent to participate Not applicable. Consent for publication Not applicable. Availability of data and materials Data sharing is not applicable to this article as no datasets were generated or analysed during the current study. Competing Interests The authors declare that they have no competing interests. Funding This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr Samuel Smith NIHR300588. DF is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data, and in the writing of this manuscript. Authors’ contributions Conceptual model development = SS, CG, SG. SMS intervention development = SG, ER, SS, LH, DF, NR, CP, BG. Information leaflet development = SG, SS, DF, LH, NR, CP. ACT intervention development = CG, SS, JC, SG, LH. Website development = SS, LH, CG, LH, SG. Supervision = SS, DF, LH, NR. Funding = SS. All authors have read and corrected draft versions of the manuscript and approved the final manuscript. Acknowledgements We would like to thank all patient representatives for their contributions. We would also like to thank Health Creatives at University College London for designing the information leaflet and website intervention components. We acknowledge the contributions of the ROSETA investigators; Michelle Collinson, Rachel Ellison, Hollie Wilkes, Suzanne Hartley, Ellen Mason, Amanda Farrin, Rebecca Walwyn, Jo Waller, Daniel Howdon, Jamie Metherell. Abbreviations AET Adjuvant endocrine therapy MOST Multiphase Optimisation Strategy IM Intervention Mapping SMS Short messaging service ER+ Oestrogen receptor-positive MRC Medical Research Council RCT Randomised Control Trial PPI Patient and Public Involvement BCT Behaviour Change Technique ACT Acceptance and Commitment Therapy CSM Common-sense model of illness representations NHS National Health Service IAPT Improving Access to Psychological Therapies References Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2018;68(6):394–424. Harrell JC, Dye WW, Harvell DME, Pinto M, Jedlicka P, Sartorius CA, et al. Estrogen Insensitivity in a Model of Estrogen Receptor–Positive Breast Cancer Lymph Node Metastasis. Cancer Research. 2007;67(21):10582–91. Early Breast Cancer Trialists Collaborative Group. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. The Lancet. 2011;378(9793):771–84. Early breast Cancer Trialists Collaborative Group. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. The Lancet. 2015;386(10001):1341–52. National Institute for Health and Care Excellence: Clinical Guidelines. Early and locally advanced breast cancer: diagnosis and management. London: National Institute for Health and Care Excellence (UK) Copyright © NICE.; 2018. Del Mastro L, Mansutti M, Bisagni G, Ponzone R, Durando A, Amaducci L, et al. Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: a multicentre, open-label, randomised, phase 3 trial. The Lancet Oncology. 2021. Tjan-Heijnen VC, van Hellemond IE, Peer PG, Swinkels AC, Smorenburg CH, van der Sangen MJ, et al. Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial. The Lancet Oncology. 2017;18(11):1502–11. Blok EJ, Kroep JR, Meershoek-Klein Kranenbarg E, Duijm-De Carpentier M, Putter H, Van Den Bosch J, et al. Optimal Duration of Extended Adjuvant Endocrine Therapy for Early Breast Cancer; Results of the IDEAL Trial (BOOG 2006-05). JNCI: Journal of the National Cancer Institute. 2018;110(1):40–8. Gnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, et al. Duration of adjuvant aromatase-inhibitor therapy in postmenopausal breast cancer. New England Journal of Medicine. 2021;385(5):395–405. Hershman DL, Kushi LH, Shao T, Buono D, Kershenbaum A, Tsai W-Y, et al. Early Discontinuation and Nonadherence to Adjuvant Hormonal Therapy in a Cohort of 8,769 Early-Stage Breast Cancer Patients. Journal of Clinical Oncology. 2010;28(27):4120–8. Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. 2012;134(2):459–78. Huiart L, Ferdynus C, Giorgi R. A meta-regression analysis of the available data on adherence to adjuvant hormonal therapy in breast cancer: summarizing the data for clinicians. Breast Cancer Research and Treatment. 2013;138(1):325–8. Partridge AH, Wang PS, Winer EP, Avorn J. Nonadherence to adjuvant tamoxifen therapy in women with primary breast cancer. J Clin Oncol. 2003;21(4):602–6. Makubate B, Donnan PT, Dewar JA, Thompson AM, McCowan C. Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. British Journal of Cancer. 2013;108(7):1515–24. McCowan C, Wang S, Thompson AM, Makubate B, Petrie DJ. The value of high adherence to tamoxifen in women with breast cancer: a community-based cohort study. British Journal of Cancer. 2013;109(5):1172–80. Inotai A, Ágh T, Maris R, Erdősi D, Kovács S, Kaló Z, et al. Systematic review of real-world studies evaluating the impact of medication non-adherence to endocrine therapies on hard clinical endpoints in patients with non-metastatic breast cancer. Cancer Treatment Reviews. 2021;100. Moon Z, Moss-Morris R, Hunter MS, Hughes LD. Understanding tamoxifen adherence in women with breast cancer: a qualitative study. British Journal of Health Psychology. 2017;22(4):978–97. Cahir C, Guinan E, Dombrowski SU, Sharp L, Bennett K. Identifying the determinants of adjuvant hormonal therapy medication taking behaviour in women with stages I–III breast cancer: A systematic review and meta-analysis. Patient Education and Counseling. 2015;98(12):1524–39. Brett J, Fenlon D, Boulton M, Hulbert-Williams NJ, Walter FM, Donnelly P, et al. Factors associated with intentional and unintentional non-adherence to adjuvant endocrine therapy following breast cancer. European Journal of Cancer Care. 2018;27(1):e12601. Toivonen K, Williamson T, Carlson L, Walker L, Campbell T. Potentially Modifiable Factors Associated with Adherence to Adjuvant Endocrine Therapy among Breast Cancer Survivors: A Systematic Review. Cancers. 2020;13(1):107. Hurtado-De-Mendoza A, Cabling ML, Lobo T, Dash C, Sheppard VB. Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review. Clinical Breast Cancer. 2016;16(4):247–55. Heiney SP, Parker PD, Felder TM, Adams SA, Omofuma OO, Hulett JM. A systematic review of interventions to improve adherence to endocrine therapy. Breast Cancer Research and Treatment. 2019;173(3):499–510. Finitsis DJ, Vose BA, Mahalak JG, Salner AL. Interventions to promote adherence to endocrine therapy among breast cancer survivors: A meta-analysis. Psycho-Oncology. 2019;28(2):255–63. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews. 2014. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008:a1655. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021:n2061. O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019;9(8):e029954. Bartholomew Eldredge LK, Markham CM, Ruiter RA, Fernández ME, Kok G, Parcel GS. Planning health promotion programs: an intervention mapping approach: John Wiley & Sons; 2016. Collins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS and Behavior. 2016;20(S1):197–214. Collins LM. The Preparation Phase of MOST. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p. 35–65. Duncan E, O'Cathain A, Rousseau N, Croot L, Sworn K, Turner KM, et al. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open. 2020;10(4):e033516. Moon Z, Moss-Morris R, Hunter MS, Carlisle S, Hughes LD. Barriers and facilitators of adjuvant hormone therapy adherence and persistence in women with breast cancer: a systematic review. Patient Preference and Adherence. 2017;11:305–22. Lin JH, Zhang SM, Manson JE. Predicting Adherence to Tamoxifen for Breast Cancer Adjuvant Therapy and Prevention. Cancer Prevention Research. 2011;4(9):1360–5. Lin C, Clark R, Tu P, Bosworth HB, Zullig LL. Breast cancer oral anti-cancer medication adherence: a systematic review of psychosocial motivators and barriers. Breast Cancer Research and Treatment. 2017;165(2):247–60. Van Liew JR, Christensen AJ, De Moor JS. Psychosocial factors in adjuvant hormone therapy for breast cancer: an emerging context for adherence research. Journal of Cancer Survivorship. 2014;8(3):521–31. Banning M. Adherence to adjuvant therapy in post-menopausal breast cancer patients: a review. European Journal of Cancer Care. 2012;21(1):10–9. Chlebowski RT, Kim J, Haque R. Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings. Cancer Prevention Research. 2014;7(4):378–87. Lambert LK, Balneaves LG, Howard AF, Gotay CC. Patient-reported factors associated with adherence to adjuvant endocrine therapy after breast cancer: an integrative review. Breast Cancer Research and Treatment. 2017;167(3):615–33. Roberts MC, Wheeler SB, Reeder-Hayes K. Racial/Ethnic and socioeconomic disparities in endocrine therapy adherence in breast cancer: a systematic review. American journal of public health. 2015;105(S3):e4-e15. Gotay C, Dunn J. Adherence to long-term adjuvant hormonal therapy for breast cancer. Expert Review of Pharmacoeconomics & Outcomes Research. 2011;11(6):709–15. Collins LM. Introduction to the Factorial Optimization Trial. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p. 67–113. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The Behavior Change Technique Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an International Consensus for the Reporting of Behavior Change Interventions. Annals of Behavioral Medicine. 2013;46(1):81–95. Kincaid JP, Fishburne Jr RP, Rogers RL, Chissom BS. Derivation of new readability formulas (automated readability index, fog count and flesch reading ease formula) for navy enlisted personnel. Naval Technical Training Command Millington TN Research Branch; 1975. Collins LM, Trail JB, Kugler KC, Baker TB, Piper ME, Mermelstein RJ. Evaluating individual intervention components: making decisions based on the results of a factorial screening experiment. Translational Behavioral Medicine. 2014;4(3):238–51. Collins LM. The Completion of the Optimization Phase. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p. 227–66. Owusu C, Buist DSM, Field TS, Lash TL, Thwin SS, Geiger AM, et al. Predictors of Tamoxifen Discontinuation Among Older Women With Estrogen Receptor–Positive Breast Cancer. Journal of Clinical Oncology. 2008;26(4):549–55. Kimmick G, Edmond SN, Bosworth HB, Peppercorn J, Marcom PK, Blackwell K, et al. Medication taking behaviors among breast cancer patients on adjuvant endocrine therapy. The Breast. 2015;24(5):630–6. Wouters H, Stiggelbout AM, Bouvy ML, Maatman GA, Van Geffen ECG, Vree R, et al. Endocrine Therapy for Breast Cancer: Assessing an Array of Women's Treatment Experiences and Perceptions, Their Perceived Self-Efficacy and Nonadherence. Clinical Breast Cancer. 2014;14(6):460–7. Atkins L, Fallowfield L. Intentional and non-intentional non-adherence to medication amongst breast cancer patients. European Journal of Cancer. 2006;42(14):2271–6. Brett J, Boulton M, Fenlon D, Hulbert-Williams NJ, Walter FM, Donnelly P, et al. Adjuvant endocrine therapy after breast cancer: a qualitative study of factors associated with adherence. Patient Preference and Adherence. 2018;12:291–300. Moon Z, Moss-Morris R, Hunter MS, Hughes LD. More than just side-effects: The role of clinical and psychosocial factors in non-adherence to tamoxifen. British Journal of Health Psychology. 2017;22(4):998–1018. Moon Z, Moss-Morris R, Hunter MS, Norton S, Hughes LD. Nonadherence to tamoxifen in breast cancer survivors: A 12 month longitudinal analysis. Health Psychology. 2019;38(10):888–99. Peddie N, Agnew S, Crawford M, Dixon D, Macpherson I, Fleming L. The impact of medication side effects on adherence and persistence to hormone therapy in breast cancer survivors: A qualitative systematic review and thematic synthesis. The Breast. 2021;58:147–59. Moon Z, Moss-Morris R, Hunter MS, Hughes LD. Measuring illness representations in breast cancer survivors (BCS) prescribed tamoxifen: Modification and validation of the Revised Illness Perceptions Questionnaire (IPQ-BCS). Psychology & Health. 2017;32(4):439–58. Jacobs JM, Walsh EA, Park ER, Berger J, Peppercorn J, Partridge A, et al. The Patient’s Voice: Adherence, Symptoms, and Distress Related to Adjuvant Endocrine Therapy After Breast Cancer. International Journal of Behavioral Medicine. 2020;27(6):687–97. Cahir C, Dombrowski SU, Kelly CM, Kennedy MJ, Bennett K, Sharp L. Women’s experiences of hormonal therapy for breast cancer: exploring influences on medication-taking behaviour. Supportive Care in Cancer. 2015;23(11):3115–30. Pan Y, Heisig SR, Von Blanckenburg P, Albert U-S, Hadji P, Rief W, et al. Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study. Breast Cancer Research and Treatment. 2018;168(3):667–77. Moon Z, Moss-Morris R, Hunter MS, Hughes LD. Understanding tamoxifen adherence in women with breast cancer: A qualitative study. British Journal of Health Psychology. 2017;22(4):978–97. Clancy C, Lynch J, OConnor P, Dowling M. Breast cancer patients’ experiences of adherence and persistence to oral endocrine therapy: A qualitative evidence synthesis. European Journal of Oncology Nursing. 2020;44:101706. Gold M, Dunn LB, Phoenix B, Paul SM, Hamolsky D, Levine JD, et al. Co-occurrence of anxiety and depressive symptoms following breast cancer surgery and its impact on quality of life. European Journal of Oncology Nursing. 2016;20:97–105. Martino G, Catalano A, Agostino RM, Bellone F, Morabito N, Lasco CG, et al. Quality of life and psychological functioning in postmenopausal women undergoing aromatase inhibitor treatment for early breast cancer. PLOS ONE. 2020;15(3):e0230681. Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014;17(3):252–9. Pullens MJ, De Vries J, Roukema JA. Subjective cognitive dysfunction in breast cancer patients: a systematic review. Psycho-oncology. 2010;19(11):1127–38. Underwood E, Rochon P, Moineddin R, Lee P, Wu W, Pritchard K, et al. Cognitive sequelae of endocrine therapy in women treated for breast cancer: a meta-analysis. Breast cancer research and treatment. 2018;168(2):299–310. Tan EH, Wong ALA, Tan CC, Wong P, Tan SH, Ang LEY, et al. Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach. Breast Cancer Research and Treatment. 2021;188(3):779–88. Hall LH, Clark J, Smith SG, Graham CD. Patient and healthcare professional co-development of an Acceptance and Commitment Therapy intervention to support Hormone Therapy decision-making and wellbeing in women with breast cancer. Journal of Psychosocial Oncology. 2021. Lambert LK, Balneaves LG, Howard AF, Chia SK, Gotay CC. Understanding adjuvant endocrine therapy persistence in breast Cancer survivors. BMC Cancer. 2018;18(1):732. Liu Y, Malin JL, Diamant AL, Thind A, Maly RC. Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider–patient communication. Breast Cancer Research and Treatment. 2013;137(3):829–36. Ell K, Vourlekis B, Xie B, Nedjat-Haiem FR, Lee P-J, Muderspach L, et al. Cancer treatment adherence among low-income women with breast or gynecologic cancer. Cancer. 2009;115(19):4606–15. Yu K-D, Zhou Y, Liu G-Y, Li B, He P-Q, Zhang H-W, et al. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients’ persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Research and Treatment. 2012;134(1):307–13. Ziller V, Kyvernitakis I, Knöll D, Storch A, Hars O, Hadji P. Influence of a patient information program on adherence and persistence with an aromatase inhibitor in breast cancer treatment - the COMPAS study. BMC Cancer. 2013;13(1):407. Hadji P, Blettner M, Harbeck N, Jackisch C, Lück HJ, Windemuth-Kieselbach C, et al. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cance. Annals of Oncology. 2013;24(6):1505–12. Neven P, Markopoulos C, Tanner M, Marty M, Kreienberg R, Atkins L, et al. The impact of educational materials on compliance and persistence rates with adjuvant aromatase inhibitor treatment: First-year results from the Compliance of ARomatase Inhibitors AssessmenT In Daily practice through Educational approach (CARIATIDE) study. The Breast. 2014;23(4):393–9. Markopoulos C, Neven P, Tanner M, Marty M, Kreienberg R, Atkins L, et al. Does patient education work in breast cancer? Final results from the global CARIATIDE study. Future Oncology. 2015;11(2):205–17. Graetz I, McKillop CN, Stepanski E, Vidal GA, Anderson JN, Schwartzberg LS. Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. Journal of Cancer Survivorship. 2018;12(4):431–40. Hershman DL, Unger JM, Hillyer GC, Moseley A, Arnold KB, Dakhil SR, et al. Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105. Journal of Clinical Oncology. 2020;38(19):2122–9. Tan EH, Wong ALA, Tan CC, Wong P, Tan SH, Ang LEY, et al. Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder. The Breast. 2020;53:77–84. Krok-Schoen JL, Naughton MJ, Young GS, Moon J, Poi M, Melin SA, et al. Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Cancer Control. 2019;26(1):107327481988328. Heisig SR, Shedden-Mora MC, Von Blanckenburg P, Schuricht F, Rief W, Albert U-S, et al. Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. Psycho-Oncology. 2015;24(2):130–7. Castaldi M, Safadjou S, Elrafei T, McNelis J. A Multidisciplinary Patient Navigation Program Improves Compliance With Adjuvant Breast Cancer Therapy in a Public Hospital. American Journal of Medical Quality. 2017;32(4):406–13. Moon Z, Moss-Morris R, Hunter MS, Goodliffe S, Hughes LD. Acceptability and feasibility of a self-management intervention for women prescribed tamoxifen. Health Education Journal. 2019;78(8):901–15. Moon Z, Moss-Morris R, Hunter MS, Hughes LD. Development of a self-management intervention to improve tamoxifen adherence in breast cancer survivors using an Intervention Mapping framework. Supportive Care in Cancer. 2020;29:3329–38. Bhandari S, Ngo P, Kute B, Mandadi M, Pitman WA, Wu X, et al. Adherence to anti-estrogen therapy in women with hormone receptor-positive breast cancer utilizing bubble packaging: a pilot study. Breast Cancer Research and Treatment. 2019;177(2):395–9. Labonté M, Guillaumie L, Dionne A, Dorval M, Nabi H, Lemieux J, et al. Development of a community pharmacy-based intervention to enhance adherence to adjuvant endocrine therapy among breast cancer survivors guided by the Intervention Mapping approach. Research in Social and Administrative Pharmacy. 2020;16(12):1724–36. Getachew S, Addisse A, Taylor L, Kantelhardt EJ. Improving Access and Adherence to Endocrine Therapy With Nurse-Based Intervention. Journal of Global Oncology. 2018;4(3):15. Fink AK, Gurwitz J, Rakowski W, Guadagnoli E, Silliman RA. Patient Beliefs and Tamoxifen Discontinuance in Older Women With Estrogen Receptor—Positive Breast Cancer. Journal of Clinical Oncology. 2004;22(16):3309–15. Jacob Arriola KR, Mason TA, Bannon KA, Holmes C, Powell CL, Horne K, et al. Modifiable risk factors for adherence to adjuvant endocrine therapy among breast cancer patients. Patient Education and Counseling. 2014;95(1):98–103. Phillips LA, Cohen J, Burns E, Abrams J, Renninger S. Self-management of chronic illness: the role of 'habit' versus reflective factors in exercise and medication adherence. J Behav Med. 2016;39(6):1076–91. Gardner B, Lally P. Modelling habit formation and its determinants. The psychology of habit. 2018:207–29. Danner UN, Aarts H, De Vries NK. Habit Formation and Multiple Means to Goal Attainment: Repeated Retrieval of Target Means Causes Inhibited Access to Competitors. Personality and Social Psychology Bulletin. 2007;33(10):1367–79. Gardner B, Lally P, Wardle J. Making health habitual: the psychology of ‘habit-formation’ and general practice. British Journal of General Practice. 2012;62(605):664–6. Lally P, Gardner B. Promoting habit formation. Health psychology review. 2013;7(1):137–58. Lally P, Van Jaarsveld CH, Potts HW, Wardle J. How are habits formed: Modelling habit formation in the real world. European journal of social psychology. 2010;40(6):998–1009. Gardner B, Rebar A, Lally P. Habit Interventions. In: M. Hagger, L. Cameron, K. Hamilton, N. Hankonen, Lintunen T, editors. The Handbook of Behaviour Change. Cambridge: Cambridge University; 2020. p. pp. 599–616. Carey RN, Connell LE, Johnston M, Rothman AJ, De Bruin M, Kelly MP, et al. Behavior change techniques and their mechanisms of action: a synthesis of links described in published intervention literature. Annals of Behavioral Medicine. 2019;53(8):693–707. Morrissey EC, Corbett TK, Walsh JC, Molloy GJ. Behavior change techniques in apps for medication adherence: a content analysis. American journal of preventive medicine. 2016;50(5):e143-e6. Thakkar J, Kurup R, Laba T-L, Santo K, Thiagalingam A, Rodgers A, et al. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease. JAMA Internal Medicine. 2016;176(3):340. Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PloS one. 2014;9(2):e88166. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, et al. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS med. 2013;10(1):e1001362. Vervloet M, Linn AJ, van Weert JCM, de Bakker DH, Bouvy ML, van Dijk L. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc. 2012;19(5):696–704. Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, De Walque D, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS (London, England). 2011;25(6):825. Rottman BM, Marcum ZA, Thorpe CT, Gellad WF. Medication adherence as a learning process: insights from cognitive psychology. Health Psychology Review. 2017;11(1):17–32. Von Blanckenburg P, Schuricht F, Albert U-S, Rief W, Nestoriuc Y. Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial. BMC Cancer. 2013;13(1):426. Horne R, Weinman J. Self-regulation and Self-management in Asthma: Exploring The Role of Illness Perceptions and Treatment Beliefs in Explaining Non-adherence to Preventer Medication. Psychology & Health. 2002;17(1):17–32. Leventhal H, Diefenbach M, Leventhal EA. Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cognitive therapy and research. 1992;16(2):143–63. Bingel U, Team FtPC. Avoiding Nocebo Effects to Optimize Treatment Outcome. JAMA. 2014;312(7):693–4. Webster RK, Weinman J, Rubin GJ. How does the side-effect information in patient information leaflets influence peoples’ side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England. Health Expectations. 2017;20(6):1411–20. Webster RK, Rubin GJ. Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions. Frontiers in Psychiatry. 2019;9:775. Graham CD, Gouick J, Krahé C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clinical Psychology Review. 2016;46:46–58. Bower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, et al. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. Journal of Clinical Oncology. 2021;39(31):3473–84. Hann KEJ, McCracken LM. A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science. 2014;3(4):217–27. Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. European Journal of Cancer Care. 2015;24(1):15–27. Hulbert-Williams NJ, Storey L. Psychological flexibility correlates with patient-reported outcomes independent of clinical or sociodemographic characteristics. Supportive Care in Cancer. 2016;24(6):2513–21. Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psycho-Oncology. 2011;22(2):459–64. Mosher CE, Secinti E, Li R, Hirsh AT, Bricker J, Miller KD, et al. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial. Supportive Care in Cancer. 2018;26(6):1993–2004. Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and Commitment Therapy: Model, processes and outcomes. Behaviour Research and Therapy. 2006;44(1):1–25. González-Fernández S, Fernández-Rodríguez C, Mota-Alonso MJ, García-Teijido P, Pedrosa I, Pérez-Álvarez M. Emotional state and psychological flexibility in breast cancer survivors. European Journal of Oncology Nursing. 2017;30:75–83. Fernandes-James C, Graham CD, Batterham AM, Harrison SL. Association of psychological flexibility with engagement in pulmonary rehabilitation following an acute exacerbation of chronic obstructive pulmonary disease. Chronic Respiratory Disease. 2019;16:147997311988089. Harrison A, Scott W, Timmins L, Graham CD, Harrison AM. Investigating the potentially important role of psychological flexibility in adherence to antiretroviral therapy in people living with HIV. AIDS Care. 2021;33(3):337–46. Cheung K, Mak Y. Association between Psychological Flexibility and Health Beliefs in the Uptake of Influenza Vaccination among People with Chronic Respiratory Diseases in Hong Kong. International Journal of Environmental Research and Public Health. 2016;13(2):155. Graham CD, McCracken LM, Harrison A, Walburn J, Weinman J. Outlining an Acceptance and Commitment Therapy approach to treatment non-adherence. British Journal of Health Psychology. 2021. Hall LH, King N, Graham CD, Green SM, Barber A, Neal RD, et al. Strategies to self-manage side-effects of adjuvant endocrine therapy among breast cancer survivors: an umbrella review of empirical evidence and clinical guidelines. Journal of Cancer Survivorship. In Press. Peate M, Saunders C, Cohen P, Hickey M. Who is managing menopausal symptoms, sexual problems, mood and sleep disturbance after breast cancer and is it working? Findings from a large community-based survey of breast cancer survivors. Breast Cancer Research and Treatment. 2021;187(2):427–35. Lambert LK, Balneaves LG, Howard AF, Chia SLK, Gotay CC. Healthcare Provider Perspectives on Adherence to Adjuvant Endocrine Therapy after Breast Cancer. Current Oncology. 2021;28(2):1472–82. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348(mar07 3):g1687-g. Bartlett YK, Farmer A, Rea R, French DP. Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies. Journal of Medical Internet Research. 2020;22(5):e15989. Bartlett YK, Kenning C, Crosland J, Newhouse N, Miles LM, Williams V, et al. Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes. BMC Health Services Research. 2021;21(1). Bartlett YK, Farmer AJ, French DP. Does a text message intervention to support medication adherence in type 2 diabetes produce changes in hypothesised mediating variables, and what does change in these variables mean for medication adherence? JMIR Formative Research. In Press. Gardner B, Sheals K, Wardle J, McGowan L. Putting habit into practice, and practice into habit: a process evaluation and exploration of the acceptability of a habit-based dietary behaviour change intervention. International Journal of Behavioral Nutrition and Physical Activity. 2014;11(1):1–13. Ali EE, Cheung KL, Lee CP, Leow JL, Yap KY-L, Chew L. Prevalence and determinants of adherence to oral adjuvant endocrine therapy among breast cancer patients in Singapore. Asia-Pacific journal of oncology nursing. 2017;4(4):283. MHRA. Best practice guidance on patient information leaflets. 2014. Rose MR, Norton S, Vari C, Edwards V, McCracken L, Graham CD, et al. Acceptance and Commitment Therapy for Muscle Disease (ACTMus): protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases. BMJ Open. 2018;8(10):e022083. Harris R. ACT Minfully 2021 [Available from: https://libanswers.liverpool.ac.uk/faq/49511#:~:text=Adding%20 a%20website%20as%20a,Type%20to%20'Web%20Page'. McGregor LM, Von Wagner C, Vart G, Yuen WC, Raine R, Wardle J, et al. The impact of supplementary narrative-based information on colorectal cancer screening beliefs and intention. BMC Cancer. 2015;15(1):1–9. Bennett KF, Von Wagner C, Robb KA. Supplementing factual information with patient narratives in the cancer screening context: a qualitative study of acceptability and preferences. Health Expectations. 2015;18(6):2032–41. Clark DM. Realizing the Mass Public Benefit of Evidence-Based Psychological Therapies: The IAPT Program. Annual Review of Clinical Psychology. 2018;14(1):159–83. Collins LM, Dziak JJ, Li R. Design of experiments with multiple independent variables: a resource management perspective on complete and reduced factorial designs. Psychological methods. 2009;14(3):202–24. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443–51. Horne R, Chapman SCE, Parham R, Freemantle N, Forbes A, Cooper V. Understanding Patients’ Adherence-Related Beliefs about Medicines Prescribed for Long-Term Conditions: A Meta-Analytic Review of the Necessity-Concerns Framework. PLoS ONE. 2013;8(12):e80633. Johns SA, Stutz PV, Talib TL, Cohee AA, Beck-Coon KA, Brown LF, et al. Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3‐arm pilot randomized controlled trial. Cancer. 2020;126(1):211–8. Harrow A, Dryden R, McCowan C, Radley A, Parsons M, Thompson AM, et al. A hard pill to swallow: a qualitative study of women's experiences of adjuvant endocrine therapy for breast cancer. BMJ Open. 2014;4(6):e005285-e. Lewson AB, Johns SA, Krueger E, Chinh K, Kidwell KM, Mosher CE. Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. Supportive Care in Cancer. 2021;29(7):3487–95. Guastaferro K, Collins LM. Achieving the Goals of Translational Science in Public Health Intervention Research: The Multiphase Optimization Strategy (MOST). American Journal of Public Health. 2019;109(S2):S128-S9. Collins LM, Chakraborty B, Murphy SA, Strecher V. Comparison of a phased experimental approach and a single randomized clinical trial for developing multicomponent behavioral interventions. Clinical Trials. 2009;6(1):5–15. Nahum-Shani I, Dziak JJ. Multilevel Factorial Designs in Intervention Development. In: Collins LM, Kugler KC, editors. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: Advanced Topics. Cham: Springer International Publishing; 2018. p. 47–87. Smith SG, Ellison R, Hall LH, Clark J, Hartley S, Mason E, et al. Acceptance and Commitment Therapy to Support Medication Decision-making and Quality of Life in Women With Breast Cancer: Protocol for a Pilot Randomised Controlled Trial, 12 July 2021, PREPRINT (Version 1) available at Research Square [ https://doi.org/10.21203/rs.3.rs-679400/v1] . 2021. Pears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychology Review. 2021;15(1):159–84. Walburn J, Sainsbury K, Foster L, Weinman J, Morgan M, Norton S, et al. Why? What? How? Using an Intervention Mapping approach to develop a personalised intervention to improve adherence to photoprotection in patients with Xeroderma Pigmentosum. Health Psychology and Behavioral Medicine. 2020;8(1):475–500. Tables Table 1. Adapted Intervention mapping framework Stage Task What was done? Stage 1- Needs assessment Conduct a needs assessment Literature review of the problem of non-adherence, barriers to adherence, and existing interventions to support adherence to AET Describe the context for the intervention including population Population of interest described State intervention goals Overall goal for the intervention established Stage 2- Intervention objectives Decide on behavioural determinants to be targeted Selection of behavioural determinants based on needs assessment and context of intervention Specify intervention component objectives for behavioural outcomes Intervention component objectives stated Create a conceptual model Conceptual model created, detailing causal change pathways and hypothesised interactions between components Stage 3- Intervention Design Choose theory and evidence-based change methods Theories relevant to each determinant identified were considered Select or design practical applications to deliver change methods Existing interventions explored, informed by the needs assessment and practical applications considered Stage 4- Intervention development Establish the format of the intervention Intervention components finalized based on stage 3 Create intervention materials; draft and refine materials Intervention development work completed Refine intervention materials Stakeholder input from clinicians, patients and research team Stage 5- Implementation planning Consider how the intervention will be implemented Implementations in the development phase discussed, and MOST optimization criterion outlined Stage 6- Evaluation plan Prepare process evaluation questions Process evaluation planned Develop indicators and measures for assessment Assessment measures decided on Specify the plans for evaluation design Optimization plan considered Complete the evaluation plan Progress of evaluation stated Outline expected interactions between intervention components Hypothesised interactions between intervention components outlined and explained Key: MOST = Multiphase Optimisation Strateg Table 2. Summary of barriers to AET adherence. Factor associated with adherence Explanation Evidence Experience of side effects Barrier: Increased frequency and intensity of side effects (11, 18, 20, 34, 37-40, 50-53) Medication beliefs Facilitator: more beliefs about the necessity of AET Barrier: more concerns about AET (11, 18-20, 32, 34-36, 38, 40). Illness perceptions Facilitators: beliefs that certain lifestyle behaviours can cause a recurrence Barriers: low risk perception of recurrence, high tamoxifen consequences, belief that psychological factors cause a recurrence (51, 52, 54) Knowledge/ information available Barriers: Lack of knowledge of side effects and the mechanisms of AET (34). Psychological distress Barriers: Increased distress (including depression and anxiety) (20, 55). Forgetfulness Barriers: forgetting to take medication, memory difficulties (18, 36, 56) Social support Facilitators: Increased social support (11, 32, 34, 35, 37, 38, 52). Self-efficacy Facilitators: Increased self-efficacy (32, 34, 38, 40) Patient-physician communication Facilitators: Better patient-physician relationship (20, 32, 35, 37, 38) Key: AET = adjuvant endocrine therapy Table 3. Existing interventions supporting adherence to AET in women with breast cancer Authors Description of Intervention Intervention modality AET type Design Key results (adherence related outcomes) Theory that informed the intervention Ell et al., (2009)(69) Written information plus structured ‘patient navigation’ phone interviews consisting of education, addressing barriers to adherence, problem solving, self-management support and emotional support. Written information and telephone All 2 arm RCT- enhanced usual care (information) vs written information plus patient navigation No significant difference; 67% vs 69% (p=0.80). Health Belief model and socio-cultural explanatory theory Yu et al., (2012) (70) PACT materials used. Patient education (welcome pack and quarterly newsletters) with information about breast cancer and adherence. Follow up reminder calls. Written information and telephone Anastrozole or letrozole Prospective, multicentre controlled observational study No significant difference; 95.9% vs 95.8% one-year persistence rate (p=0.95). None reported Ziller et al., (2013) (71) COMPAS study. Letter group: 8 personalized motivational reminder letters were sent over 2 years with information on topics side effects and treatment. A breast cancer information leaflet containing information on topics such as nutrition and sport. Reminder phone calls: 8 telephone calls over 2 years which used motivational interviewing to address any questions, challenges to adherence, provide information and reminders. Written information/ telephone AI 3 arm RCT- usual care vs letters vs telephone calls No significant difference in adherence in primary analysis. In post hoc analysis when pooling the intervention arms, adherence increased significantly in the intervention arms vs control (p=0.039). Learning theory Hadji et al., (2013) (72) PACT Program: educational materials sent to participants (9 mailed letters and brochures), monthly reminders on persistence to endocrine therapy, gift items sent e.g. 7 day tablet box, pocket mirror. Educational materials included information on relevant issues such as side effects, efficacy, nutrition, communication. Written information Anastrozole RCT- usual care vs written information No significant difference in compliance at 12 months (p=0.81). None mentioned Neven et al., (2014) (73) CARIATIDE program. PACT materials used- welcome pack and 9 letters and brochures mailed out, containing information on side effects, exercise, diet, communication. Written information AI Randomized, parallel group observational study; usual care vs intervention No significant difference in compliance between arms at 12 months (p=0.4524). In Finland/Sweden, compliance was significantly higher in the intervention arm (p=0.0246). None mentioned Graetz et al., (2018) (75) App: Web based app in which participants asked to record symptoms and report adherence in the past 7 days. Alerts sent to care team for any concerns. App+ reminder: Web based app in which participants asked to record symptoms and report adherence in the past 7 days. Alerts sent to care team for any concerns. Weekly reminders sent to use the app via text or email. App and text or email AI Pilot RCT- app use only vs app use plus reminders to use app Proportion of patients adherent in the experimental group (100%) was greater than control group (72.7%); p<0.05. None mentioned Heisig et al., (2015) (79) Enhanced information leaflet and 15-minute phone calls sessions including information on the mechanisms of AET, benefits and side effects. Written information and telephone Any Interventional single cohort study Greater adherence observed at 3‐month follow‐up. None mentioned Markopoulas et al., (2015) (74) PACT materials. Educational materials sent to participants 9 times in one year, consisting of information on side effects, communication, sport, nutrition, benefits, tips on how to take AET. Written information Anastrozole or letrozole RCT- standard care vs intervention No significant difference in compliance or persistence between the groups at 12 months. None mentioned Castaldi et al., (2017) (80) Patient navigation program. Initial visit include assessment of barriers to adherence. Navigator provides reminder calls prior to follow up appointments, meets patients at outpatient appointments and on day of surgery, and a financial consultation where required. Patient navigation Tamoxifen and AI Non randomized, historical care vs navigated care 68.6% adherence in standard care vs 100% in patient navigation (p<0.0001). None mentioned Hershman et al., (2020) (76) SMS messages sent twice weekly over 36 months. Content included overcoming barriers to medication adherence, cues to action, statements related to medication efficacy and reinforcements of the recommendation to take the medication. 40 messages repeated over intervention. Text messaging AI RCT; text messages vs no text messages No significant difference between text messages (55.55%) and no text messages (55.4%) at 36 months. None mentioned Moon et al., (2019) (81, 82) Self-directed paper booklet designed in line with CBT and behaviour change theory. Included sections to modify beliefs about recurrence and the medication, to help manage side effects and to increase perceived behavioural control. Written information Tamoxifen Pilot trial; no control group Primary outcomes were feasibility and retention. Change from 100% to 91% who were non adherent after intervention. D=0.31 for improvement of unintentionally non adherent women. Common sense model and theory of planned behaviour Bhandari et al., (2019) (83) Prescriptions given in a 30-day bubble pack with labelled day of the week; dispensed as 1- or 3-month supply. Medication packaging Tamoxifen and AI’s Single arm prospective investigational pilot study Suggestion of improved adherence with bubble packaging (no control arm) None mentioned Tan et al., (2020) (77) Weekly SMS reminders sent on a Monday morning reading "Mdm please be reminded to take your anti-cancer medicine as instructed by your doctor. Take one tablet once every day.". Text messaging All Open level, multi centre prospective RCT Higher percentage of adherence in SMS (72.4%) vs standard care (59.5%) at 6 months (p=0.034), but not at one year (p=0.617). No difference in serum hormone levels. None mentioned Krok-Schoen et al., (2019) (78) Daily text message reminders focusing on initiation, continuation and adherence to prescribed dose; 14 messages repeated. Dynamic intervention in which participants complete weekly surveys on an app. Participants received feedback based on survey responses; either encouraging messages or problem solving. Physicians notified and patient has option to leave voice message and share with physician. Text messaging and app Tamoxifen or AI Pilot trial; no control group Significant improvement for self-reported medication adherence (p=0.015), significant decreases in oestradiol, oestrogen and estrone hormone levels (p<0.001). None mentioned Labonte et al., (2020) (84) Community based pharmacy intervention; motivational interviewing given by pharmacists in brief individual consultations. Discussions focused on mode of action of AET, side effect coping and benefits of the medication. In person (pharmacist) All Intervention mapping development N/A- development paper Theory of planned behaviour, motivational interviewing Getachew et al., (2018) (85) Breast care nurses were trained as navigators to improve patient adherence in rural Ethiopia Breast nurse navigators Tamoxifen RCT N/A- protocol abstract only None mentioned Key: RCT= Randomised Control Trial; PACT= Patients Anastrozole Compliance to Therapy; COMPAS = Compliance in Adjuvant treatment of primary breast cancer Study; CARIATIDE = Compliance of Aromatase Inhibitors Assessment in daily practice through educational approach. AET = adjuvant endocrine therapy; SMS = short messaging service; CBT = cognitive behavioural therapy; AI = aromatase inhibitor. Table 4. Registered clinical trials of interventions to support adjuvant endocrine therapy in breast cancer patients Clinical Trial ID Description of intervention Intervention modality Design Population Status Adherence related outcomes NCT03592771 Web-enabled app in which patients input their treatment-related symptoms or changes. Reported symptoms integrate into electronic health care records. Concerning symptoms trigger an alert to the care team and contact is made. App group: receive weekly reminders (via text or email) to use the app App + Feedback group: receive weekly reminders and feedback about their use of the app App and text/email reminders 3 arm RCT; usual care vs app vs app plus feedback AI or Tamoxifen Recruiting Electronic pillbox monitoring NCT04142476 Motivational, semi-directed interviews with pharmacists over 18 months, to motivate adherence to hormone therapy. In person No randomization; Single group assignment Any AET Recruiting Data from electronic pillboxes NCT04861896 Smartphone app with a 12-week program regarding psychoeducation about breast cancer and hormone therapy, stress awareness and management, social support, and enhanced communication and intimacy skills. App No randomization; single group assignment Hispanic/Latina women, any AET Recruiting (for pilot trial) Adherence to Refills and Medications Scale NCT04824339 8 week aerobic and resistance program with virtual group based supervised exercise sessions twice per week (60 minutes). Optional information on healthy eating. Virtual exercise sessions via Zoom Randomized, partial crossover; immediate intervention vs delayed intervention Tamoxifen or AI Recruiting Voils DOSE nonadherence measure (secondary outcome) NCT04651452 Values affirmation group: participants asked to write an essay monthly for 6 months about values important to them. Reflective journal group: Participants will be asked to write monthly essays for 6 months about their daily routines, and values not important to them that could be important to others. Online website or postal RCT; value affirmation vs reflective journaling AI Recruiting Morisky measure of adherence, and electronic pill bottle monitoring NCT04719455 HCP visits; baseline visit will include motivation, collaborative goal setting and plans for adherence and physical activity. Follow ups with HCP include personalized visual reports of medication intake, number of steps, and to identify any problems and solutions. In person Pilot RCT; usual care vs self-management intervention Any AET Recruiting (for pilot trial) Number of days of missed medication (adherence is a secondary outcome) NCT04176809 One compulsory workshop about AET benefits. 2 optional workshops about nutrition and fatigue monthly. Monthly reminder letters sent including tips to deal with side effects. Regular HRQoL assessments using a tablet before consultations. In person, and letters RCT; standard care vs routine HRQoL assessment and therapeutic information Any AET Not yet recruiting Morisky Green Levine scale NCT04554927 Web based application (no further information provided) App RCT; Web application vs active comparator (personalized schedule of medical follow up) Any AET Recruiting Morisky 8 item adherence scale NCT04086875 Twice weekly SMS messages providing educational information for 6 months to motivate adherence Text messaging RCT; usual care vs text messages Any AET Recruiting Smart pill bottles opening data NCT02883361 Motivational enhancement therapy. 4 in person counselling sessions over 12 months. Motivational interviewing to increase motivation and decrease ambivalence about change. In person RCT; Motivational interviewing vs attention control AI Not yet recruiting Medication possession ration CN-01810939 Breast cancer information leaflet. Personalized letter to remind, motivate and inform patients about AET. Additional reminder phone calls from a study nurse. Post, phone calls 3 arm RCT; standard information vs personalized letters telephone calls No information No information Self-report and prescription refill NCT03949270 Daily text messages asking whether the patient has taken their medication, Weekly messages asking about side effects. Monthly messages asking about barriers to adherence. Contact from physician if there are any concerning responses. Text messaging RCT; usual care vs text messaging AI Recruiting Persistence to therapy at one year NCT02707471 Self-management intervention. 10 calls over 6 months delivered by a nurse, and tailored interactive voice messages based on adherence data. Focus on strategies for managing side effects, behavioural strategies to improve adherence and education. Phone calls RCT; self-management intervention vs general health education control Any AET Recruiting Smart pill bottles (bottle opening and percent of pills remaining) NCT02850939 Interactive smartphone app that was personalized and culturally tailored. Additional support from a patient navigator. Focus on patient education, reporting side effects, delivery of self care advice, simplified communication between patient and oncology team. App and patient navigation RCT; usual care vs app and patient navigation Any AET Recruiting Prescribing and refill records and self-report data via mobile app. NCT03837496 6 weekly one hour sessions in small groups of 2-3; psychoeducation, problem solving barriers to adherence, cognitive behavioural skills, relaxation training, coping strategies for side effects, and mindfulness techniques. Two individual 15 minute semi-structured interview with therapist one and two months after the intervention to problem solve ongoing challenges with adherence. Videoconferencing RCT; STRIDE intervention vs medication monitoring control (pilot trial) Any AET Recruiting MEMS caps, MARS-5 (adherence is secondary outcome due to pilot trial) Key: RCT= Randomised Control Trial; AI = aromatase inhibitor; AET = adjuvant endocrine therapy; DOSE = Domains of Subjective extent of nonadherence; HCP = Health care practitioner; HRQoL = Health related quality of life; STRIDE = Symptom-targeted randomized intervention for distress and adherence to adjuvant endocrine therapy; MEMS = Medication event monitoring system; MARS-5; Medication adherence report scale. Note: Where there were multiple publications regarding an ongoing trial (e.g. study protocols and development papers), the trial is only displayed in the ongoing interventions table to avoid repetition. Table 5. Summary of intervention components to target determinants. Determinant Intervention component objective Strategy Intervention component Description of intervention component BCT’s targeted Management of side effects Increase ability to self-manage side effects Reduce impact of side effects Inform patients of self-management strategies for common side effects Self-management website A website for self-management of side effects. Strategies to manage side effects with a summary of the strength of evidence for that side effect in a patient-friendly manner. Side effects included are arthralgia, fatigue, vulvovaginal symptoms, gastrointestinal symptoms, hot flushes and sleep difficulties. 1.2, 3.1, 3.3, 4.1, 5.1, 5.3, 5.6, 6.2, 6.3, 9.1, 11.1, 12.2, 12.5, 12.6 Medication and illness beliefs Increase beliefs about the necessity of using AET beliefs Reduce concerns about AET Support formation of accurate illness perceptions Provide information on how AET works and the benefits of AET. Provide information on the prevalence of side effects, answer common concerns about AET. Provide information on the mechanism of AET and the benefits of AET to enhance coherence, personal and treatment control Information Leaflet A written information leaflet with five different elements: An explanation of how AET works, including medical diagrams Information and infographics about the benefits of AET Information about the prevalence of side effects from AET Answers to common concerns about AET Quotes from breast cancer survivors about their experiences taking AET, and a statement highlighting that the leaflet was co-designed As above 1.2, 4.1, 4.3, 5.1, 5.2, 5.6, 6.2, 6.3, 9.1, 9.2, 11.2, 13.2 Knowledge Learn about AET, including how it works, the benefits and side effects of it Provide information about AET, it’s mechanism of action, benefits and side effect information Information Leaflet As above Forgetfulness Learn strategies to remember to take AET Support the habit formation of daily medication taking and associated activities such as ordering and collecting prescriptions SMS messages SMS messages providing practical strategies to support taking medication regularly each day. Messages are sent in the following frequency: · 2 weeks of daily messages · 8 weeks of twice weekly messages · 6 weeks of weekly messages 1.2, 1.4*, 2.3*, 7.1*, 7.3, 8.3*, 11.3, 12.1)*, 12.5)* Psychological distress Reduce psychological distress Increase psychological flexibility ACT A guided-self help intervention based on ACT principles involving four skills: Mindfulness: broad awareness of the here-and-now. Unhooking: engaging and disengaging from thoughts as suits your purpose, and letting go of struggles with yourself. Follow your values: ongoing engagement with your values; consistently choosing to move in meaningful directions. Living beyond labels: Taking a perspective beyond labels and responding to yourself in ways that help you grown and learn The modules contain home practice tasks and are supported by individual sessions with a psychologist in the following format: 15 minute introduction 3x 25 minute sessions following modules 1, 2 and 3 15 minute closing session following module 4 1.1, 1.2, 1.5, 1.6 a , 1.7, 2.3, 2.4, 3.1 b , 4.1, 4.4, 5.2, 5.4, 5.6, 6.1, 6.2, 8.1, 8.2, 8.7, 9.1, 9.2, 10.9, 11.3, 11.4, 13.4, 15.2, 15.3 Key: BCT= Behavior change technique; AET = adjuvant endocrine therapy; SMS= short messaging service; ACT = Acceptance and commitment therapy. *Refers to the BCT’s selected for messages to be based on during a one day workshop with behavior change experts. a Note: goals may be conceptualized differently in ACT (i.e. based on values) to how they are conceptualized in this taxonomy b Note: The definition of this BCT states “advise on, arrange or provide social support OR non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling”. The coding of this BCT reflects the encouragement provided as part of the support sessions. It does not reflect ‘non-contingent praise or reward for performance of the behaviour’, which is not consistent with an ACT approach. 1.1 Goal setting (behavior); 1.2 Problem solving; 1.4 Action Planning; 1.5 Review behavior goals; 1.6 Discrepancy between current behavior and goal; 1.7 Review outcome goal(s); 2.3 Self-monitoring of behavior; 2.4 Self-monitoring of outcome(s) of behavior; 3.1 Social support (unspecified); 3.3 Social support (emotional); 4.1 Instruction on how to perform a behavior; 4.3 Re-attribution; 4.4 Behavioral Experiments; 5.1 Information about health consequences; 5. Salience of Consequences; 5.3 Information about social and environmental consequences; 5.4 Monitoring of emotional consequences; 5.6 Information about emotional consequences; 6.1 Demonstration of the behavior; 6.2 Social comparison; 6.3 Information about others’ approval; 7.1 Prompts/cues; 7.3 Reduce prompts/cues; 8.1 Behavioral practice/ rehearsal; 8.2 Behavior substitution; 8.3 Habit Formation; 8.7; Graded tasks; 9.1 Credible source; 9.2 Pros and Cons; 10.9 Self-reward; 11.1 Pharmacological support; 11.2 Reduce negative emotions; 11.3 Conserving mental resources; 11.4 Paradoxical Instructions; 12.1 Restructuring the physical environment; 12.2 Restructuring the social environment; 12.5 Adding objects to the environment (12.5); 12.6 Body changes; 13.2 Framing/ reframing; 13.4 Valued self-identity; 15.2 Mental rehearsal of successful performance; 15.3 Focus on past success Table 6. Readability of intervention components. Intervention Component Flesch-Kincaid Grade Age range SMS messages 7.6 12-13 years old Information leaflet 7.1 12-13 years old ACT participant manuals Module 1 6.1 11-12 years old Module 2 6.9 11-12 years old Module 3 7.8 12-13 years old Module 4 8.3 13-14 years old Website 7.2 12-13 years old Key: SMS= short messaging service; ACT = Acceptance and commitment therapy. Additional Declarations No competing interests reported. Supplementary Files AdditionalFile1.docx Additional file 1 (PDF)- Intervention component examples. This provides examples of the four intervention components that were developed; SMS messages, information leaflet, ACT participant manuals and the side-effect management website. AdditionalFile2.docx Additional file 2 (Word document)- TIDieR checklist. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Major revision 31 Mar, 2022 Reviews received at journal 08 Mar, 2022 Reviewers agreed at journal 04 Mar, 2022 Reviewers invited by journal 04 Mar, 2022 Editor assigned by journal 04 Mar, 2022 Editor invited by journal 24 Feb, 2022 Submission checks completed at journal 24 Feb, 2022 First submitted to journal 07 Jan, 2022 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-1239166","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":75779607,"identity":"9198ad50-df30-4cfc-95fa-551628ff1d4f","order_by":0,"name":"Sophie M. C. Green","email":"","orcid":"","institution":"Leeds Institute of Health Sciences, University of Leeds","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Sophie","middleName":"M. C.","lastName":"Green","suffix":""},{"id":75779608,"identity":"75b4cc1c-6ac8-4868-93c0-9d52491f858e","order_by":1,"name":"David P. French","email":"","orcid":"","institution":"Manchester Centre for Health Psychology, University of Manchester","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"David","middleName":"P.","lastName":"French","suffix":""},{"id":75779609,"identity":"ad9f565d-387c-406c-93a5-2b6a77264420","order_by":2,"name":"Christopher D. Graham","email":"","orcid":"","institution":"Department of Psychology, Queen's University Belfast","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Christopher","middleName":"D.","lastName":"Graham","suffix":""},{"id":75779610,"identity":"ab2dd30f-a1bc-48bd-8e43-2ad9e9e6e9a1","order_by":3,"name":"Louise H. Hall","email":"","orcid":"","institution":"Leeds Institute of Health Sciences, University of Leeds","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Louise","middleName":"H.","lastName":"Hall","suffix":""},{"id":75779611,"identity":"81b8736a-d2c3-49aa-bf4f-3cac82ae0e10","order_by":4,"name":"Nikki Rousseau","email":"","orcid":"","institution":"Leeds Institute of Clinical Trials, University of Leeds","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Nikki","middleName":"","lastName":"Rousseau","suffix":""},{"id":75779612,"identity":"5032bc59-f9e7-4f7a-bb73-545d7de757e8","order_by":5,"name":"Robbie Foy","email":"","orcid":"","institution":"Leeds Institute of Health Sciences, University of Leeds","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Robbie","middleName":"","lastName":"Foy","suffix":""},{"id":75779613,"identity":"8067db16-323b-4706-9e81-26633bce12f8","order_by":6,"name":"Jane Clark","email":"","orcid":"","institution":"St. James’s University Hospital, Leeds Teaching Hospitals NHS Trust","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jane","middleName":"","lastName":"Clark","suffix":""},{"id":75779614,"identity":"f0c0276b-2075-449e-8c73-e3d3220191a2","order_by":7,"name":"Catherine Parbutt","email":"","orcid":"","institution":"St. James’s University Hospital, Leeds Teaching Hospitals NHS Trust","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Catherine","middleName":"","lastName":"Parbutt","suffix":""},{"id":75779615,"identity":"61c1bf6f-9bf4-4730-a0c0-89be5c33bab4","order_by":8,"name":"Erin Raine","email":"","orcid":"","institution":"Leeds Institute of Health Sciences, University of Leeds","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Erin","middleName":"","lastName":"Raine","suffix":""},{"id":75779616,"identity":"d03e3a06-d00f-4e83-a479-e1aa32ab6923","order_by":9,"name":"Benjamin Gardner","email":"","orcid":"","institution":"Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Benjamin","middleName":"","lastName":"Gardner","suffix":""},{"id":75779617,"identity":"39011a07-7fa0-4716-b592-b30b7446971e","order_by":10,"name":"Galina Velikova","email":"","orcid":"","institution":"Leeds Institute of Medical Research, University of Leeds, St Jame's Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Galina","middleName":"","lastName":"Velikova","suffix":""},{"id":75779618,"identity":"fb7b337d-54cf-4ce2-9c6a-278aa9c77c04","order_by":11,"name":"Sally Moore","email":"","orcid":"","institution":"","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Sally","middleName":"","lastName":"Moore","suffix":""},{"id":75779619,"identity":"9be19fdb-12f8-435f-a42f-faf2d99abf61","order_by":12,"name":"Jacqueline Buxton","email":"","orcid":"","institution":"","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jacqueline","middleName":"","lastName":"Buxton","suffix":""},{"id":75779620,"identity":"e1b83802-14ff-48e1-b7ab-ced35b38b58f","order_by":13,"name":"Samuel G. Smith","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2UlEQVRIie3RMQrCMBSA4SeFuDzpWlHoFVoCnSq9SqTgBbxAodCOrl16h4IXiLxLKDjoYCcHNwt2MK2bQ1o3h/xkSIYPXngAJtO/JkCiPVUX/LytEUTI5Tz9iYCQoUdjiZtMb9W1OSMn63C5t+DaCXJPRzyJwVGIGgNisV9m4BcSudASQKYIKYLBYpbApALkcmCwuic8tZ8vbCEaJCAh6IlnIVMH1h3RD0bdXzaEDjE+LzMnLohttd9387w+NSFFdp5eH/c2XO3ydO9oB/vagTNukSaTyWTS9wYyC0PPUfy2eQAAAABJRU5ErkJggg==","orcid":"","institution":"Leeds Institute of Health Sciences, University of Leeds","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Samuel","middleName":"G.","lastName":"Smith","suffix":""}],"badges":[],"createdAt":"2022-01-07 16:14:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1239166/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1239166/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":17674113,"identity":"24e6c92f-7e20-42e4-ab98-392207c172fe","added_by":"auto","created_at":"2022-01-26 19:07:07","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":153435,"visible":true,"origin":"","legend":"\u003cp\u003eConceptual Model\u003c/p\u003e","description":"","filename":"Figure1ConceptualModel.jpg","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/68f1b63c4300ffb8db4a0085.jpg"},{"id":17674115,"identity":"7c842ea7-3258-4089-8081-d6ce857f0cb2","added_by":"auto","created_at":"2022-01-26 19:07:07","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":292587,"visible":true,"origin":"","legend":"\u003cp\u003eBehaviour change techniques present in intervention components\u003c/p\u003e","description":"","filename":"Figure2BehaviourChangeTechniquespresentinInterventioncomponents.jpg","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/50d43297f0d4f92bddf04c10.jpg"},{"id":17674240,"identity":"572a9f62-e2f8-42ce-9c03-7f89d7aa01a1","added_by":"auto","created_at":"2022-01-26 19:10:07","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":126921,"visible":true,"origin":"","legend":"\u003cp\u003eSummary of Assessment Measures\u003c/p\u003e","description":"","filename":"Figure3SummaryofAssessmentMeasures.jpg","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/9b861159f8035cc91296eb41.jpg"},{"id":17674241,"identity":"0662cc8d-384f-44fe-8641-e157e3a0f348","added_by":"auto","created_at":"2022-01-26 19:10:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":695651,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/8def92b5-2d62-4db4-983a-45274e27009d.pdf"},{"id":17674116,"identity":"886e8675-d2d4-4e12-ae81-fde0fd1bb801","added_by":"auto","created_at":"2022-01-26 19:07:07","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":1933390,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 1 (PDF)- Intervention component examples. This provides examples of the four intervention components that were developed; SMS messages, information leaflet, ACT participant manuals and the side-effect management website.\u003c/p\u003e","description":"","filename":"AdditionalFile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/cdac5c044bd773cb74076ae1.docx"},{"id":17674112,"identity":"e3857f69-7dcb-4e5c-b5a3-df16018464dc","added_by":"auto","created_at":"2022-01-26 19:07:07","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":30949,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 2 (Word document)- TIDieR checklist.\u003c/p\u003e","description":"","filename":"AdditionalFile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-1239166/v1/8de216cce09610cbc58b7cf1.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy","fulltext":[{"header":"Background","content":"\u003cp\u003eBreast cancer is the most common cause of cancer death in women (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Around 75% of breast cancers are oestrogen receptor-positive (ER+)(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Adjuvant endocrine therapy (AET), including tamoxifen and aromatase inhibitors (AIs; anastrozole, letrozole, exemestane) are prescribed to women with ER+ breast cancer to reduce the risk of cancer recurrence and mortality (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). AET is prescribed for 5-10 years (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), with 7-8 years potentially the optimal duration (\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). However, up to three-quarters of patients do not take AET as prescribed (\u003cspan additionalcitationids=\"CR11 CR12\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Non-adherence and non-persistence (not continuing to take the medication for the prescribed duration) are linked to an increased risk of recurrence, lower survival and reduced quality-adjusted life years (\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Improving adherence to AET could reduce healthcare costs associated with cancer recurrence (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eModifiable barriers to AET adherence have been identified (\u003cspan additionalcitationids=\"CR18 CR19\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Most existing interventions do not target multiple factors associated with adherence, and predominantly consist of solely educational interventions, such as leaflets (\u003cspan additionalcitationids=\"CR22\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Such interventions have either been ineffective or yield small effect sizes (\u003cspan additionalcitationids=\"CR22\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). This is characteristic of interventions aiming to support adherence across a wide range of chronic conditions, highlighting the need for improved interventions to support adherence more generally (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Considerations of theory in interventions aiming to support AET adherence are often lacking, with little transparency of the intervention development process. The UK Medical Research Council Framework (MRC) for developing and evaluating complex interventions, and INDEX guidance (Identifying and assessing different approaches to developing complex interventions) suggest interventions should consider theory in a systematic manner to aid replication and implementation (\u003cspan additionalcitationids=\"CR26\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Intervention mapping (IM) is a systematic approach used to develop theory and evidence-based health interventions. It consists of six stages that cover designing, implementing and evaluating an intervention (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe AET adherence trials published to date are mostly evaluated using parallel groups randomised controlled trials (RCTs). RCTs can definitively evaluate whether an intervention package as a whole has a statistically significant effect compared with a comparator. However, RCTs alone are unable to explain which components of a complex intervention affect the outcome, whether there are interactions between intervention components, and whether the benefits of an intervention component are justified based on resource demands. The Multiphase Optimisation Strategy (MOST) addresses these limitations (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) by optimising interventions based on the performance of individual intervention components relative to resource constraints. MOST consists of three phases: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) preparation, in which intervention components are developed; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) optimisation, in which efficient experimental designs, which estimate main effects and interactions between intervention components, are used to build an optimal intervention package; and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) evaluation, in which the optimised intervention package is evaluated, typically using a parallel groups RCT.\u003c/p\u003e \u003cp\u003eThere are important factors to consider when developing interventions within the MOST framework. These include ensuring each intervention component targets a specific mediating variable, that there is minimal overlap between the content of the intervention components, and that thought is given to the challenges of delivering all intervention components within a single package (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). Combining the IM and MOST frameworks enables these considerations of MOST to be acknowledged systematically throughout every stage of development within IM. This paper describes the development of an intervention package to support AET adherence in women with early-stage breast cancer, aiming to provide an exemplar of how to incorporate IM into the MOST framework.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eWe progressed through six stages of IM in line with published guidance (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e) (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). We followed the Guidance for reporting intervention development studies in health research (GUIDED) (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003e[Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e]\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec3\"\u003e\n \u003ch2\u003eStage 1: Needs assessment\u003c/h2\u003e\n \u003cp\u003eThe needs assessment involved three sub-stages: (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) a literature review to understand the extent of non-adherence in women prescribed AET; (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) a literature review to understand the barriers to AET adherence, predominantly focusing on existing reviews identified through backward citation searching (\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e); and (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) a rapid review and search of trial registries to identify published interventions and ongoing trials addressing AET adherence. The terms \u0026ldquo;hormone therapy\u0026rdquo; \u0026ldquo;breast cancer\u0026rdquo;, \u0026ldquo;adherence\u0026rdquo;, \u0026ldquo;intervention\u0026rdquo; and their variations were used. One author (SG) screened the texts and extracted data. The needs assessment informed the primary aims of the intervention package.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec4\"\u003e\n \u003ch2\u003eStage 2: Intervention Objectives\u003c/h2\u003e\n \u003cp\u003eModifiable determinants of AET adherence to be targeted in the intervention package were selected based on the results of stage 1. For each determinant chosen, specific objectives for an intervention component to target were defined. Stage 2 considered how IM could be incorporated into MOST. An important aspect of the preparation phase of MOST is the conceptual model (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e), similar to the logic model produced in IM. A conceptual model details how each intervention component is expected to change the outcome. It is recommended that each intervention component targets one specific mediating variable to aid decision making within the optimisation phase (\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e). The intervention components should be reasonably independent to ensure one component does not depend on the presence of another. This means that participants\u0026rsquo; experiences of a component should not be affected by which of the other components they may receive (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e). Conceptual model development was iterative; draft illustrations of the model were created, discussed within the research team, and with Patient and Public Involvement (PPI) members.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec5\"\u003e\n \u003ch2\u003eStage 3: Intervention design\u003c/h2\u003e\n \u003cp\u003eFor each determinant of AET adherence that we identified and selected in stages 1 and 2, existing interventions and associated literature were explored to identify suitable theories, evidence-based behaviour change methods and practical strategies that could address them. The research team, in collaboration with PPI members, used this evidence to discuss which strategies were most likely to be effective and implementable within the UK healthcare system.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec6\"\u003e\n \u003ch2\u003eStage 4: Intervention Development\u003c/h2\u003e\n \u003cp\u003eFour intervention components were developed; two new components and two adapted from existing interventions. Clinician, researcher and patient views were considered throughout. To aid future replication, the intervention components were coded onto the Behaviour Change Techniques taxonomy (BCTTv1) by one author (SG) who had completed BCTTv1 training (\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e). Component coding was discussed between members of the research team (SG, SS, CG, LH). Disagreements were discussed and resolved. A Flesch-Kincaid reading age and grade level was calculated for each component (\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec7\"\u003e\n \u003ch2\u003eStage 5: Implementation planning\u003c/h2\u003e\n \u003cp\u003eImplementation factors such as cost, time and delivery method were considered. A criterion by which the intervention will be optimised was specified, as recommended by the MOST framework. The optimisation criterion operationalises the primary outcome, and key considerations that the optimised intervention should fit within, such as effectiveness, cost and time (\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec8\"\u003e\n \u003ch2\u003eStage 6: Evaluation plan\u003c/h2\u003e\n \u003cp\u003eWe planned how the intervention components will be optimised and evaluated. The research team, in collaboration with PPI members and stakeholders selected the outcome measures to be used for assessment, the evaluation design, and the process evaluation research questions. A protocol for a pilot trial to assess the feasibility of an optimisation trial was prepared. We specified expected interactions between intervention components, based on theoretical assumptions identified in Stage 3. The a priori specification of hypothesised interactions is important, as components forming the interactions will be prioritised when deciding the optimised intervention package (\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec9\"\u003e\n \u003ch2\u003ePatient and Public Involvement (PPI)\u003c/h2\u003e\n \u003cp\u003eOur PPI panel of five members met remotely with two researchers (SG, ER) every 2-3 months throughout the development phase. The panel comprised five women with a diagnosis of breast cancer and experience of taking AET, recruited by advertising through a charity supporting people affected by cancer. Members were compensated for their time.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eStage 1: Needs assessment (findings from literature reviews)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eExtent of nonadherence\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAdherence to AET is suboptimal, with up to 73% not taking it as prescribed (11, 36). A large number of women discontinue AET within the first year (46). \u0026nbsp;Adherence diminishes over time, with up to 50% of women being non-adherent within five years (10, 13). Unintentional nonadherence (e.g. forgetting to take medication) may be more prevalent than intentional nonadherence (e.g. deciding to miss a tablet) (47-49).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFactors associated with adherence and nonadherence\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBarriers to and facilitators of AET adherence were identified (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eSide-effects\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThe frequency, severity and inability to manage side-effects are common barriers to AET adherence and persistence (11, 18, 20, 34, 37-40, 57). However, some reviews have questioned this relationship, citing inconsistent evidence (32, 37). Qualitative studies highlight reasons for non-adherence including the impact of side-effects on quality of life (58), side-effects outweighing the benefits (53, 58), a lack of understandable information about the range and intensity of side-effects (53, 56), and women feeling unsupported in managing side-effects (50, 53, 58). There is a clear demand for information about side-effects and their management (59).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eMedication beliefs and illness perceptions\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eNecessity beliefs and concerns about AET, and the cost-benefit balance between these are associated with reduced adherence (11, 18-20, 32, 34-36, 38, 40). For example, adherent women tend to report strong necessity beliefs, such as \u0026ldquo;Tamoxifen is keeping me alive\u0026rdquo;, AET helps them to feel in control, and that AET will enable them to stay alive for their family (56, 58). In contrast, less adherent women report more concerns, such as AET benefits not being worth the reduced quality of life, and worry about the chance of cancer elsewhere (58). Representations of breast cancer, such as believing the likelihood of recurrence is low, are also associated with lower adherence (51, 52). \u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eKnowledge of medication\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eLower knowledge about AET is associated with reduced adherence (34). Women consistently report receiving insufficient information about AET (50, 58). Approximately one fifth of breast cancer survivors in a Dutch survey did not know how AET worked, but wanted further information, and a third did not know how large the risk reduction effect was (48). \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePsychological distress\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eImmediatley following active treatment, approximately half of women with breast cancer report higher levels of psychological distress than observed in the general population (20, 60, 61). Psychological distress in breast cancer can include rumination and worry about breast cancer recurrence, difficulties in returning to \u0026lsquo;normal\u0026rsquo;, and distress from AET side effects (53, 58, 59). Higher levels of distress are associated with lower adherence (20, 55), although some inconsistencies with this relationship have been observed (37, 62).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eForgetfulness\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eWomen with breast cancer commonly report memory problems following chemotherapy, which can increase forgetfulness and consequently unintentional nonadherence (18, 32, 36, 56, 63-65). \u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eSocial support\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eWomen often feel abandoned when ending active treatment and being discharged from care (66). Higher social support from family, friends and other breast cancer survivors are associated with improved adherence and persistence (11, 32, 34, 35, 37, 38, 52, 67). \u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eSelf-efficacy\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eSelf-efficacy is associated with higher adherence (32, 34, 38). This includes self-efficacy in the patient-physician interaction (confidence in the ability to get medical information from a physician (34, 38, 68)), and perceived self-efficacy in relation to learning about and taking AET (32, 34, 38).\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePatient-physician communication\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003ePatient-reported positive relationships with physicians are associated with higher adherence (20, 32, 35, 37, 38), specifically, the quality and person-centeredness of the relationship, frequency of communication, and sufficiency of information received about AET (38).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eExisting interventions supporting adherence\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWe identified 16 published trials evaluating interventions targeting adherence to AET (Table 3) and 15 ongoing trials (Table 4). There was little high-quality evidence that these interventions were effective. Of the 16 published interventions, six reported statistically significant improvement in adherence. Two of those with significant findings were pilot trials and therefore were not designed to examine efficacy, two found significant findings in post-hoc analyses, and for one, a significant effect was not maintained at follow up. Six published trials composed only of educational materials which were not effective in supporting adherence (69-74).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDigital health interventions appeared to be increasingly prevalent. Four existing interventions (75-78), and three registered trials involved text messaging either solely or as part of a multi-component intervention. Two published interventions (75, 78) and five registered trials included an app or website. One registered trial is using videoconferencing. Of the four published digital interventions, three assessed and reported acceptability to patients (75, 77, 78). The theoretical basis and development process were inadequately described for most published interventions. \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e[Table 3 and 4]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eIntervention Goals\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe needs assessment established the overall goal of the programme; to improve AET adherence in women with early-stage breast cancer, using a multi-component intervention. All barriers to AET adherence identified in Stage 1 were considered in Stage 2. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 2: Intervention Objectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBased on findings from Stage 1, and following discussion within the research team and agreement from patient representatives, four main intervention targets were selected; living with side effects, medication and illness beliefs, forgetfulness and psychological distress. These cover a range of intentional and unintentional barriers to adherence. Table 5 summarises identified determinants and the specific intervention component objectives.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIllness perceptions and knowledge can affect medication beliefs through providing an understanding of how the medication works, which can enhance beliefs about its necessity (86, 87). We therefore targeted knowledge in combination with medication beliefs. Three determinants were not chosen as mediating variables within the conceptual model: social support; self-efficacy; and patient-physician communication. These factors are likely to be addressed by the intervention components already chosen. For example, support from a psychological therapist as part of one of the proposed components has the potential to reduce feelings of abandonment, thus targeting one aspect of social support.\u003c/p\u003e\n\u003cp\u003eThe selection of determinants based on the needs assessment, informed the conceptual model. A conceptual model, as recommended by the MRC framework, can provide a visual representation of the theoretical basis of the intervention and can improve generalisability and replicability of the intervention (26). The development of a conceptual model is a key part of the preparation phase of MOST, in which separate intervention component targets are specified (30). Stages 1 and 2 of IM informed the intervention target, pathway and outcome aspects of the model (Figure 1). Stages 3 and 4 of IM provide detail on the individual intervention components. For two determinants (forgetfulness and psychological distress), there are additional stages in the conceptual model to demonstrate the pathway to adherence, described in detail in Stage 3.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFigure 1. Conceptual Model\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 3: Intervention design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWithin factorial designs commonly used within the MOST framework, each component must be distinct, with minimal duplication of content across components (30, 41). This was considered in Stages 3 and 4. \u0026nbsp;Taking the four main intervention component targets in Stage 2 (memory, illness and medication beliefs, psychological distress, side-effects), Stage 3 focused on identifying theory-based change methods and practical strategies to target these mediators.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eForgetfulness\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIf medication taking becomes habitual and less reliant on memory, unintentional nonadherence may reduce (88-92). Habit theory stipulates there are multiple phases in forming a habit; deciding to act, acting on that decision, and doing so repeatedly in a manner conducive to development of behaviour cue associations (89, 92, 93). Table 5 details behaviour change techniques (BCTs) related to habit formation that were feasible to target (92, 94-96). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMobile messaging interventions are increasingly used to promote adherence to medications, and could be cost-effective for promoting habit formation (97-99). Meta-analyses and systematic reviews have highlighted the significant positive effects SMS interventions could have upon medication adherence in long-term conditions, although none included women with breast cancer (97, 100). Individual studies of SMS interventions to promote adherence by women with breast cancer have shown mixed results (76-78). These interventions did not target habit formation specifically, and often repeated the same messages, which could cause response fatigue (97, 98, 101). \u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMedication and illness beliefs\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eInformation provision can support the formation of medication beliefs (102, 103). The Necessity-Concerns framework suggests patients weigh up the benefits and costs when considering a medication (104). An extended version of the commonsense model of illness representations (CSM) highlights that cognitive and emotional illness representations, in addition to medication beliefs, influence adherence (105). \u0026nbsp;Illness representations have been correlated with necessity and concern beliefs in women with AET (54), suggesting they could be targeted together. Providing positively framed and accurate written information about the benefits and risks of AET could increase necessity beliefs and reduce unhelpful concerns and illness representations (86, 87, 103, 106-108).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePsychological distress\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWithin a range of long-term conditions including cancer, Acceptance and Commitment Therapy (ACT) can reduce psychological distress (109, 110) and improve functioning and quality of life (109-115). ACT is a newer type of cognitive behavioural therapy, that aims to help people engage in activity they find enriching and meaningful, even in objectively difficult situations (for example being diagnosed with cancer), by engendering a quality called psychological flexibility (116). Psychological flexibility involves individuals approaching experiences with openness and awareness to engage more fully with their own overarching goals and values (116). Psychological inflexibility is associated with psychological distress in breast cancer survivors (117). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePreliminary studies show psychological flexibility is positively correlated with treatment uptake and adherence in long term conditions, and that ACT could be helpful for improving medication adherence (109, 118-121). ACT could improve overall wellbeing and reduce psychological distress by enabling individuals to function effectively alongside common emotional experiences that occur in this population (66). \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLiving with side-effects\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eMany side-effects women experience while taking AET can be managed without speaking to a healthcare professional (122). Many women taking AET already self-manage their symptoms, and most want more support to do this (123). In previous co-development work, patient representatives and healthcare professionals suggested that a website would allow patients to access side-effect management resources when required (66). Demand for an online resource detailing evidence-based solutions to manage side-effects has also been reported elsewhere (124).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs a result of Stage 3, the practical strategies to target each determinant were confirmed, to be developed in Stage 4. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 4: Intervention Development\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFour intervention components were developed using distinct formats: SMS messages, an information leaflet, ACT sessions, and a side-effect management website (Additional file 1). The same considerations with regard to MOST were applied here as in Stage 3 in attempting to develop standalone components distinct from one another (30). As a result, the four intervention components largely targeted a range of separate BCTs, with some minimal overlap (Figure 2, Table 5). Readability of the components ranged between 11 and 14 years old (Table 6). The 12-item \u0026lsquo;Template for Intervention Description and Replication\u0026rsquo; (TIDieR) checklist describes the intervention components (125) (Additional file 2). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e[Table 5]\u003c/p\u003e\n\u003cp\u003eFigure 2. Behaviour change techniques present in intervention components\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSMS Development\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSMS messages were co-developed using an established method for producing acceptable messages with high fidelity to the intended BCT (126). This method has previously produced SMS messages that maintained acceptability and fidelity to intended BCTs when sent within a feasibility trial (127), and were successful in changing hypothesised mediating variables (128). For our intervention component, behaviour change experts created messages based on BCTs during a one-day workshop, and rated the BCTs on relevance to adherence and the fidelity of individual messages to the BCT they intended to target. These messages were revised following a focus group with PPI members, and rated on acceptability by breast cancer survivors. An additional group of behaviour change experts rated message fidelity to the BCT. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe SMS intervention component will begin with two weeks of daily messages, as habit formation occurs most rapidly within the first two weeks (93, 129). The messages will reduce to twice weekly for 8 weeks to ensure they do not become intrusive. One of the main reasons for nonadherence in an SMS trial was cited as forgetting at weekends due to a change of routine (77, 130). Messages sent twice weekly can support medication taking in the change of routine at weekends. The SMS messages will then reduce to weekly reminders for 6 weeks, as medication taking should become sufficiently habitual to persist despite a reduction in support. Frequent messages over a long period could lead to response fatigue; weekly messages are less susceptible to this effect (97, 98, 101). It is important to reduce the frequency so that habit formation is not dependent on reminders, but is due to creating cues for medication taking (94). To target all phases of habit formation concurrently, a combination of BCTs will be targeted throughout (92).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eInformation Leaflet Development\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe development of the information leaflet was an iterative process. It contains five elements (Table 5). PPI members were involved throughout, including planning the content, critiquing drafts, and confirming the content of the final version. Content was informed by information from reputable sources (e.g. NHS website, MacMillan and Cancer research UK). A professional design company was commissioned to create the leaflet. Design decisions, including font size, colour contrasts and layout were informed by the Medicines and Healthcare products Regulatory Agency (MHRA) best practice for information design (131). The leaflet underwent further refinement via patient feedback within PPI meetings, and clinical input from a consultant pharmacist.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcceptance and Commitment Therapy (ACT) Development\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe ACT component was developed from an existing guided self-help intervention for improving quality of life and distress in people with muscle disorders (132). The programme, which includes common ACT techniques (133), was adapted to be relevant to women with breast cancer taking AET. It was adapted by two clinical psychologists (CG and JC) with experience in ACT and breast cancer, in collaboration with members of the research team (SS and SG). PPI members provided feedback at the planning and drafting stages. The adaptation involved rewording the participant module booklets to be relevant for women taking AET, and providing additional exercises to foster self-compassion.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe resulting intervention component involves guided self-help, consisting of four distinct modules (Table 5). Module content is presented in four participant handbooks supplemented by audio files and home practice tasks, which are conceptualised to participants as enabling them to develop four specific skills related to psychological flexibility (Table 5). The four modules are supported by five individual sessions with a practitioner psychologist ranging from 15-25 minutes. The sessions provide a space to discuss the module content, to reflect on experience of practising the skills in everyday life, and to consider their helpfulness. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eWebsite Development\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe side-effect management website was developed as part of an existing intervention for women taking AET (66). The content of the website was informed by an umbrella review of self-management strategies for side-effects in AET (122) and suggestions from breast cancer survivors. Suggestions included the use of patient narratives (66), which have been shown to improve engagement (134, 135). To adapt the intervention, design elements were changed, and some sections were removed to ensure this was a standalone component only targeting side-effects (30).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 5: Implementation planning\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe optimisation criterion was based on health economic modelling (15). An intervention that is effective at showing an absolute improvement of 10% in adherence would be considered cost effective if it could be delivered for less than \u0026pound;3997 per patient. The optimisation criterion will be considered in the optimisation phase to ensure the intervention package developed is likely to be within cost-effectiveness thresholds. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDiscussions with stakeholders highlighted the following considerations for potential implementation and maintenance of the intervention components. The SMS, information leaflet, and website components all represent relatively low-cost components with relatively modest maintenance needs. Therapist hours, cost and mode of delivery were considered in detail for the ACT component. There was a large amount of stakeholder engagement throughout the ACT adaptation process, involving patient representatives, clinical psychologists and service managers to consider feasibility of implementation within the NHS (66). A guided self-help intervention was chosen by the research team in collaboration with patient representatives, as it required a lower number of therapist hours to deliver. This follows a similar approach to the Improving Access to Psychological Therapies (IAPT) model, which uses brief guided self-help interventions and has been widely implemented in the NHS (136). Remote delivery was chosen as it can benefit patients through eliminating the need to travel to sessions. Remote delivery also reduces the need to identify clinic rooms which can be a constraint in NHS psychological services. The option of telephone or videoconferencing was chosen to reduce exclusion of those without access to videoconferencing software or a private space. Guidance for how to use videoconferencing platforms will be given.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 6: Evaluation plan\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSpecification of plans for evaluation design\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWe prepared a protocol for an external exploratory pilot trial using a 2\u003csup\u003e4-1\u0026nbsp;\u003c/sup\u003efractional factorial design to determine the acceptability of the intervention components, and the feasibility of evaluating them in a larger optimisation trial (41, 137). Our evaluation plans specified an optimisation trial using a 2\u003csup\u003e4\u003c/sup\u003e factorial design, if the criteria for progression from pilot to optimisation trial are met.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eProcess evaluation questions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOur evaluation plans specified we will conduct a nested process evaluation using a mixed methods approach to evaluate the acceptability of the intervention components and experimental design, assess the fidelity of the intervention components (138), and to assess trial experience and recruitment barriers. These aims will address uncertainties regarding the feasibility of delivering a complex experimental design in a clinical setting largely familiar with more classical methods for intervention evaluation. \u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDevelopment of indicators and measures for assessment\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOutcome measures were chosen through discussion within the research team, and consensus from the Trial Management Group and Trial Steering Committee (Figure 3). To allow for analyses of mechanisms of action, assessment measures were included for all hypothesised mediators identified.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFigure 3. Summary of Assessment Measures\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompletion of the evaluation plan\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe external exploratory pilot trial (ISRCTN: 10487576) is ongoing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eExpected interactions between intervention components\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eHypothesised synergistic interactions are displayed using dashed lines in Figure 1 and explained below. No antagonistic interactions were hypothesised.\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eSMS Messages and Information Leaflet\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eHabit formation consists of multiple phases (89, 92, 93). SMS reminders will specifically target initiation, and repetition conducive to formation of cue-behaviour associations. The other phase, deciding to take the medication, relies on motivation to engage in the behaviour (92), which could be influenced by a positive necessity-concerns differential (139). Therefore, we hypothesise the information leaflet will contribute to and enhance the process of habit formation, resulting in a greater overall effect on adherence.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eACT and Information Leaflet\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eSome processes in ACT will indirectly target emotional representations of illness, that are associated with medication beliefs (32). For example, ACT-based skills that help one \u0026lsquo;unhook\u0026rsquo; from distressing thoughts, could positively affect emotional representations, such as reducing fear of recurrence (140). Reducing emotional representations such as worry may synergistically reduce concerns about AET (54). Therefore, ACT and the information leaflet together may have a greater effect on medication adherence than each component alone. \u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eWebsite and Information Leaflet\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eA major concern women have with AET is side-effects (50, 56, 58, 141). From a causal learning theory perspective to adherence, bottom-up learning (where actual experiences shape beliefs) may occur in which experiences with side-effects could shape medication beliefs (102). The website may have a positive effect on experience of side-effects, while the information leaflet may reduce concerns, leading to a more positive necessity-concerns differential (139). Consequently, combining the website and information leaflet may have an overall greater impact on adherence.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eACT and Website\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eEngagement in ACT techniques may increase willingness to tolerate side-effects when medication-taking is consistent with values, and can reduce symptom interference (111, 115, 116, 142). Engagement in the ACT component in combination with self-management strategies from the website, may therefore increase one\u0026rsquo;s ability to live well alongside side-effects, reducing their interference with meaningful functioning, consequently leading to greater adherence.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdditionally, use of the website may reduce side-effects. If the impact of side-effects is reduced, participants may be able to focus on life-enriching activities consistent with their values (116, 121, 142). Therefore, use of the website may enhance engagement in the ACT component, leading to a greater overall effect upon adherence.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe have demonstrated a transparent and systematic approach to the development of a complex behavioural intervention designed to support medication adherence in women with breast cancer. Using an iterative IM approach, and informed by the MOST framework, we used existing evidence, behavioural science theory, and patient experience to design an intervention package consisting of four intervention components (SMS, information leaflet, ACT, website) targeting key determinants of AET adherence.\u003c/p\u003e \u003cp\u003eOur study illustrates how intervention development can be guided by both IM and the MOST framework (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). Our plans to use a factorial design to optimise the intervention package will help delineate the individual contributions and interactions between the intervention components. This optimisation process aims to develop interventions that are more effective, efficient and scalable (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR143\" class=\"CitationRef\"\u003e143\u003c/span\u003e). This approach could accelerate knowledge in intervention development through improved understanding of which aspects of an intervention work and why (\u003cspan citationid=\"CR144\" class=\"CitationRef\"\u003e144\u003c/span\u003e). Combining IM with MOST could therefore be a more efficient method to develop and evaluate interventions, than using IM alone.\u003c/p\u003e \u003cp\u003eThe MOST framework influenced key points in the intervention development process, namely, ensuring each component targeted a specific mediator, consideration of how the intervention components fit together as a package, and ensuring each component was distinct. Using a staged approach such as IM enabled us to consider these points throughout development. To avoid the possibility of developing a disjointed intervention package we ensured continuity in the aesthestics of each component.\u003c/p\u003e \u003cp\u003eThe difficulty in targeting all barriers to adherence identified in the needs assessment was a challenge. For example, in terms of social support, while the developed ACT component does provide a degree of social support, it could be argued that this could be more adequately addressed with a group-based psychotherapy intervention. However, evaluating group-based intervention components using a factorial experiment would necessitate more complex, multilevel designs (\u003cspan citationid=\"CR145\" class=\"CitationRef\"\u003e145\u003c/span\u003e). While such designs exist, they are rarely used and methodological expertise and guidance are lacking. This led to uncertainty in deciding between a group-based or an individual psychotherapy component. Should we receive strong feedback from women receiving these interventions within the planned pilot trial that they would have preferred a group-based approach, we will give further consideration to evaluating it in a future optimisation trial. This decision will be guided by the results of a separate pilot trial of a group-based ACT intervention currently being undertaken by the authors (LH, SS, CG, JC) (\u003cspan citationid=\"CR146\" class=\"CitationRef\"\u003e146\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA further challenge of our approach was related to coding the active ingredients of the isolated intervention components. We felt it was important to use the same taxonomy to allow comparisons across intervention components. Therefore, we chose the BCTTv1 as this was the most widely used approach for coding behavioural interventions (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). However, the taxonomy was more challenging to apply to the ACT component than others, and several ACT specific intervention methods could not be positioned in the BCTTv1. This highlighted that the BCTTv1 taxonomy does not comprehensively cover all techniques that are involved in ACT based interventions; a limitation also acknowledged elsewhere (\u003cspan citationid=\"CR147\" class=\"CitationRef\"\u003e147\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eUsing factorial trials to evaluate multiple intervention components, as suggested by the MOST framework, is a relatively new approach in health services research. We made adaptations to IM based on time available and to include important considerations guided by MOST (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR148\" class=\"CitationRef\"\u003e148\u003c/span\u003e). Strengths of our approach include applying an established intervention development method within the MOST framework, and the systematic reporting of the intervention development process. The differing formats of the intervention components allowed each determinant to be targeted using the most appropriate modality for that determinant. However, evaluating different formats of components may confound the mechanism of the intervention with the content. For example, participants may find the ACT component more engaging due to interaction with a therapist, rather than due to the content of the component. Future work could consider whether there is an intervention format that would be appropriate for all determinants to reduce disparity between components.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eWe have developed a complex behavioural intervention package, made up of four intervention components, to support women with breast cancer in taking AET. We have also demonstrated how IM can be harnessed to develop an intervention package that targets known determinants of medication taking behaviour in this population. Guided by MOST, this intervention package will be optimised in further trials with the aim of defining effective, efficient and scalable strategies to support behaviour change.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData sharing is not applicable to this article as no datasets were generated or analysed during the current study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr Samuel Smith NIHR300588. DF is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data, and in the writing of this manuscript. \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptual model development = SS, CG, SG. SMS intervention development = SG, ER, SS, LH, DF, NR, CP, BG. Information leaflet development = SG, SS, DF, LH, NR, CP. ACT intervention development = CG, SS, JC, SG, LH. Website development = SS, LH, CG, LH, SG. Supervision = SS, DF, LH, NR. Funding = SS. All authors have read and corrected draft versions of the manuscript and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all patient representatives for their contributions. We would also like to thank Health Creatives at University College London for designing the information leaflet and website intervention components. We acknowledge the contributions of the ROSETA investigators; Michelle Collinson, Rachel Ellison, Hollie Wilkes, Suzanne Hartley, Ellen Mason, Amanda Farrin, Rebecca Walwyn, Jo Waller, Daniel Howdon, Jamie Metherell.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eAET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eAdjuvant endocrine therapy\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eMOST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eMultiphase Optimisation Strategy\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eIM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eIntervention Mapping\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eSMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eShort messaging service\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eER+\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eOestrogen receptor-positive\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eMRC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eMedical Research Council\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eRCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eRandomised Control Trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003ePPI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003ePatient and Public Involvement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eBCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eBehaviour Change Technique\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eACT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eAcceptance and Commitment Therapy\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eCSM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eCommon-sense model of illness representations\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eNHS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eNational Health Service\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"11%\"\u003e\n \u003cp\u003eIAPT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"89%\"\u003e\n \u003cp\u003eImproving Access to Psychological Therapies\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2018;68(6):394\u0026ndash;424.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarrell JC, Dye WW, Harvell DME, Pinto M, Jedlicka P, Sartorius CA, et al. Estrogen Insensitivity in a Model of Estrogen Receptor\u0026ndash;Positive Breast Cancer Lymph Node Metastasis. Cancer Research. 2007;67(21):10582\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEarly Breast Cancer Trialists Collaborative Group. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. The Lancet. 2011;378(9793):771\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEarly breast Cancer Trialists Collaborative Group. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. The Lancet. 2015;386(10001):1341\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Institute for Health and Care Excellence: Clinical Guidelines. Early and locally advanced breast cancer: diagnosis and management. London: National Institute for Health and Care Excellence (UK) Copyright \u0026copy; NICE.; 2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDel Mastro L, Mansutti M, Bisagni G, Ponzone R, Durando A, Amaducci L, et al. Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: a multicentre, open-label, randomised, phase 3 trial. The Lancet Oncology. 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTjan-Heijnen VC, van Hellemond IE, Peer PG, Swinkels AC, Smorenburg CH, van der Sangen MJ, et al. Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial. The Lancet Oncology. 2017;18(11):1502\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBlok EJ, Kroep JR, Meershoek-Klein Kranenbarg E, Duijm-De Carpentier M, Putter H, Van Den Bosch J, et al. Optimal Duration of Extended Adjuvant Endocrine Therapy for Early Breast Cancer; Results of the IDEAL Trial (BOOG 2006-05). JNCI: Journal of the National Cancer Institute. 2018;110(1):40\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, et al. Duration of adjuvant aromatase-inhibitor therapy in postmenopausal breast cancer. New England Journal of Medicine. 2021;385(5):395\u0026ndash;405.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHershman DL, Kushi LH, Shao T, Buono D, Kershenbaum A, Tsai W-Y, et al. Early Discontinuation and Nonadherence to Adjuvant Hormonal Therapy in a Cohort of 8,769 Early-Stage Breast Cancer Patients. Journal of Clinical Oncology. 2010;28(27):4120\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMurphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. 2012;134(2):459\u0026ndash;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuiart L, Ferdynus C, Giorgi R. A meta-regression analysis of the available data on adherence to adjuvant hormonal therapy in breast cancer: summarizing the data for clinicians. Breast Cancer Research and Treatment. 2013;138(1):325\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePartridge AH, Wang PS, Winer EP, Avorn J. Nonadherence to adjuvant tamoxifen therapy in women with primary breast cancer. J Clin Oncol. 2003;21(4):602\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMakubate B, Donnan PT, Dewar JA, Thompson AM, McCowan C. Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. British Journal of Cancer. 2013;108(7):1515\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcCowan C, Wang S, Thompson AM, Makubate B, Petrie DJ. The value of high adherence to tamoxifen in women with breast cancer: a community-based cohort study. British Journal of Cancer. 2013;109(5):1172\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eInotai A, \u0026Aacute;gh T, Maris R, Erdősi D, Kov\u0026aacute;cs S, Kal\u0026oacute; Z, et al. Systematic review of real-world studies evaluating the impact of medication non-adherence to endocrine therapies on hard clinical endpoints in patients with non-metastatic breast cancer. Cancer Treatment Reviews. 2021;100.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Hughes LD. Understanding tamoxifen adherence in women with breast cancer: a qualitative study. British Journal of Health Psychology. 2017;22(4):978\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCahir C, Guinan E, Dombrowski SU, Sharp L, Bennett K. Identifying the determinants of adjuvant hormonal therapy medication taking behaviour in women with stages I\u0026ndash;III breast cancer: A systematic review and meta-analysis. Patient Education and Counseling. 2015;98(12):1524\u0026ndash;39.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrett J, Fenlon D, Boulton M, Hulbert-Williams NJ, Walter FM, Donnelly P, et al. Factors associated with intentional and unintentional non-adherence to adjuvant endocrine therapy following breast cancer. European Journal of Cancer Care. 2018;27(1):e12601.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eToivonen K, Williamson T, Carlson L, Walker L, Campbell T. Potentially Modifiable Factors Associated with Adherence to Adjuvant Endocrine Therapy among Breast Cancer Survivors: A Systematic Review. Cancers. 2020;13(1):107.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHurtado-De-Mendoza A, Cabling ML, Lobo T, Dash C, Sheppard VB. Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review. Clinical Breast Cancer. 2016;16(4):247\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeiney SP, Parker PD, Felder TM, Adams SA, Omofuma OO, Hulett JM. A systematic review of interventions to improve adherence to endocrine therapy. Breast Cancer Research and Treatment. 2019;173(3):499\u0026ndash;510.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFinitsis DJ, Vose BA, Mahalak JG, Salner AL. Interventions to promote adherence to endocrine therapy among breast cancer survivors: A meta-analysis. Psycho-Oncology. 2019;28(2):255\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews. 2014.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCraig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008:a1655.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSkivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021:n2061.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eO'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019;9(8):e029954.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBartholomew Eldredge LK, Markham CM, Ruiter RA, Fern\u0026aacute;ndez ME, Kok G, Parcel GS. Planning health promotion programs: an intervention mapping approach: John Wiley \u0026amp; Sons; 2016.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS and Behavior. 2016;20(S1):197\u0026ndash;214.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM. The Preparation Phase of MOST. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p.\u0026nbsp;35\u0026ndash;65.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDuncan E, O'Cathain A, Rousseau N, Croot L, Sworn K, Turner KM, et al. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open. 2020;10(4):e033516.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Carlisle S, Hughes LD. Barriers and facilitators of adjuvant hormone therapy adherence and persistence in women with breast cancer: a systematic review. Patient Preference and Adherence. 2017;11:305\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLin JH, Zhang SM, Manson JE. Predicting Adherence to Tamoxifen for Breast Cancer Adjuvant Therapy and Prevention. Cancer Prevention Research. 2011;4(9):1360\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLin C, Clark R, Tu P, Bosworth HB, Zullig LL. Breast cancer oral anti-cancer medication adherence: a systematic review of psychosocial motivators and barriers. Breast Cancer Research and Treatment. 2017;165(2):247\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVan Liew JR, Christensen AJ, De Moor JS. Psychosocial factors in adjuvant hormone therapy for breast cancer: an emerging context for adherence research. Journal of Cancer Survivorship. 2014;8(3):521\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBanning M. Adherence to adjuvant therapy in post-menopausal breast cancer patients: a review. European Journal of Cancer Care. 2012;21(1):10\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChlebowski RT, Kim J, Haque R. Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings. Cancer Prevention Research. 2014;7(4):378\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLambert LK, Balneaves LG, Howard AF, Gotay CC. Patient-reported factors associated with adherence to adjuvant endocrine therapy after breast cancer: an integrative review. Breast Cancer Research and Treatment. 2017;167(3):615\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoberts MC, Wheeler SB, Reeder-Hayes K. Racial/Ethnic and socioeconomic disparities in endocrine therapy adherence in breast cancer: a systematic review. American journal of public health. 2015;105(S3):e4-e15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGotay C, Dunn J. Adherence to long-term adjuvant hormonal therapy for breast cancer. Expert Review of Pharmacoeconomics \u0026amp; Outcomes Research. 2011;11(6):709\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM. Introduction to the Factorial Optimization Trial. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p.\u0026nbsp;67\u0026ndash;113.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMichie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The Behavior Change Technique Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an International Consensus for the Reporting of Behavior Change Interventions. Annals of Behavioral Medicine. 2013;46(1):81\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKincaid JP, Fishburne Jr RP, Rogers RL, Chissom BS. Derivation of new readability formulas (automated readability index, fog count and flesch reading ease formula) for navy enlisted personnel. Naval Technical Training Command Millington TN Research Branch; 1975.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM, Trail JB, Kugler KC, Baker TB, Piper ME, Mermelstein RJ. Evaluating individual intervention components: making decisions based on the results of a factorial screening experiment. Translational Behavioral Medicine. 2014;4(3):238\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM. The Completion of the Optimization Phase. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). Cham: Springer International Publishing; 2018. p.\u0026nbsp;227\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOwusu C, Buist DSM, Field TS, Lash TL, Thwin SS, Geiger AM, et al. Predictors of Tamoxifen Discontinuation Among Older Women With Estrogen Receptor\u0026ndash;Positive Breast Cancer. Journal of Clinical Oncology. 2008;26(4):549\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKimmick G, Edmond SN, Bosworth HB, Peppercorn J, Marcom PK, Blackwell K, et al. Medication taking behaviors among breast cancer patients on adjuvant endocrine therapy. The Breast. 2015;24(5):630\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWouters H, Stiggelbout AM, Bouvy ML, Maatman GA, Van Geffen ECG, Vree R, et al. Endocrine Therapy for Breast Cancer: Assessing an Array of Women's Treatment Experiences and Perceptions, Their Perceived Self-Efficacy and Nonadherence. Clinical Breast Cancer. 2014;14(6):460\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtkins L, Fallowfield L. Intentional and non-intentional non-adherence to medication amongst breast cancer patients. European Journal of Cancer. 2006;42(14):2271\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrett J, Boulton M, Fenlon D, Hulbert-Williams NJ, Walter FM, Donnelly P, et al. Adjuvant endocrine therapy after breast cancer: a qualitative study of factors associated with adherence. Patient Preference and Adherence. 2018;12:291\u0026ndash;300.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Hughes LD. More than just side-effects: The role of clinical and psychosocial factors in non-adherence to tamoxifen. British Journal of Health Psychology. 2017;22(4):998\u0026ndash;1018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Norton S, Hughes LD. Nonadherence to tamoxifen in breast cancer survivors: A 12 month longitudinal analysis. Health Psychology. 2019;38(10):888\u0026ndash;99.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeddie N, Agnew S, Crawford M, Dixon D, Macpherson I, Fleming L. The impact of medication side effects on adherence and persistence to hormone therapy in breast cancer survivors: A qualitative systematic review and thematic synthesis. The Breast. 2021;58:147\u0026ndash;59.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Hughes LD. Measuring illness representations in breast cancer survivors (BCS) prescribed tamoxifen: Modification and validation of the Revised Illness Perceptions Questionnaire (IPQ-BCS). Psychology \u0026amp; Health. 2017;32(4):439\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJacobs JM, Walsh EA, Park ER, Berger J, Peppercorn J, Partridge A, et al. The Patient\u0026rsquo;s Voice: Adherence, Symptoms, and Distress Related to Adjuvant Endocrine Therapy After Breast Cancer. International Journal of Behavioral Medicine. 2020;27(6):687\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCahir C, Dombrowski SU, Kelly CM, Kennedy MJ, Bennett K, Sharp L. Women\u0026rsquo;s experiences of hormonal therapy for breast cancer: exploring influences on medication-taking behaviour. Supportive Care in Cancer. 2015;23(11):3115\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePan Y, Heisig SR, Von Blanckenburg P, Albert U-S, Hadji P, Rief W, et al. Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study. Breast Cancer Research and Treatment. 2018;168(3):667\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Hughes LD. Understanding tamoxifen adherence in women with breast cancer: A qualitative study. British Journal of Health Psychology. 2017;22(4):978\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eClancy C, Lynch J, OConnor P, Dowling M. Breast cancer patients\u0026rsquo; experiences of adherence and persistence to oral endocrine therapy: A qualitative evidence synthesis. European Journal of Oncology Nursing. 2020;44:101706.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGold M, Dunn LB, Phoenix B, Paul SM, Hamolsky D, Levine JD, et al. Co-occurrence of anxiety and depressive symptoms following breast cancer surgery and its impact on quality of life. European Journal of Oncology Nursing. 2016;20:97\u0026ndash;105.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMartino G, Catalano A, Agostino RM, Bellone F, Morabito N, Lasco CG, et al. Quality of life and psychological functioning in postmenopausal women undergoing aromatase inhibitor treatment for early breast cancer. PLOS ONE. 2020;15(3):e0230681.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014;17(3):252\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePullens MJ, De Vries J, Roukema JA. Subjective cognitive dysfunction in breast cancer patients: a systematic review. Psycho-oncology. 2010;19(11):1127\u0026ndash;38.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eUnderwood E, Rochon P, Moineddin R, Lee P, Wu W, Pritchard K, et al. Cognitive sequelae of endocrine therapy in women treated for breast cancer: a meta-analysis. Breast cancer research and treatment. 2018;168(2):299\u0026ndash;310.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTan EH, Wong ALA, Tan CC, Wong P, Tan SH, Ang LEY, et al. Facilitators and barriers to medication adherence with adjuvant endocrine therapy in women with breast cancer: a structural equation modelling approach. Breast Cancer Research and Treatment. 2021;188(3):779\u0026ndash;88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHall LH, Clark J, Smith SG, Graham CD. Patient and healthcare professional co-development of an Acceptance and Commitment Therapy intervention to support Hormone Therapy decision-making and wellbeing in women with breast cancer. Journal of Psychosocial Oncology. 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLambert LK, Balneaves LG, Howard AF, Chia SK, Gotay CC. Understanding adjuvant endocrine therapy persistence in breast Cancer survivors. BMC Cancer. 2018;18(1):732.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu Y, Malin JL, Diamant AL, Thind A, Maly RC. Adherence to adjuvant hormone therapy in low-income women with breast cancer: the role of provider\u0026ndash;patient communication. Breast Cancer Research and Treatment. 2013;137(3):829\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEll K, Vourlekis B, Xie B, Nedjat-Haiem FR, Lee P-J, Muderspach L, et al. Cancer treatment adherence among low-income women with breast or gynecologic cancer. Cancer. 2009;115(19):4606\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu K-D, Zhou Y, Liu G-Y, Li B, He P-Q, Zhang H-W, et al. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients\u0026rsquo; persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Research and Treatment. 2012;134(1):307\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZiller V, Kyvernitakis I, Kn\u0026ouml;ll D, Storch A, Hars O, Hadji P. Influence of a patient information program on adherence and persistence with an aromatase inhibitor in breast cancer treatment - the COMPAS study. BMC Cancer. 2013;13(1):407.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHadji P, Blettner M, Harbeck N, Jackisch C, L\u0026uuml;ck HJ, Windemuth-Kieselbach C, et al. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cance. Annals of Oncology. 2013;24(6):1505\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNeven P, Markopoulos C, Tanner M, Marty M, Kreienberg R, Atkins L, et al. The impact of educational materials on compliance and persistence rates with adjuvant aromatase inhibitor treatment: First-year results from the Compliance of ARomatase Inhibitors AssessmenT In Daily practice through Educational approach (CARIATIDE) study. The Breast. 2014;23(4):393\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMarkopoulos C, Neven P, Tanner M, Marty M, Kreienberg R, Atkins L, et al. Does patient education work in breast cancer? Final results from the global CARIATIDE study. Future Oncology. 2015;11(2):205\u0026ndash;17.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGraetz I, McKillop CN, Stepanski E, Vidal GA, Anderson JN, Schwartzberg LS. Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. Journal of Cancer Survivorship. 2018;12(4):431\u0026ndash;40.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHershman DL, Unger JM, Hillyer GC, Moseley A, Arnold KB, Dakhil SR, et al. Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105. Journal of Clinical Oncology. 2020;38(19):2122\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTan EH, Wong ALA, Tan CC, Wong P, Tan SH, Ang LEY, et al. Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder. The Breast. 2020;53:77\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrok-Schoen JL, Naughton MJ, Young GS, Moon J, Poi M, Melin SA, et al. Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Cancer Control. 2019;26(1):107327481988328.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeisig SR, Shedden-Mora MC, Von Blanckenburg P, Schuricht F, Rief W, Albert U-S, et al. Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. Psycho-Oncology. 2015;24(2):130\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCastaldi M, Safadjou S, Elrafei T, McNelis J. A Multidisciplinary Patient Navigation Program Improves Compliance With Adjuvant Breast Cancer Therapy in a Public Hospital. American Journal of Medical Quality. 2017;32(4):406\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Goodliffe S, Hughes LD. Acceptability and feasibility of a self-management intervention for women prescribed tamoxifen. Health Education Journal. 2019;78(8):901\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon Z, Moss-Morris R, Hunter MS, Hughes LD. Development of a self-management intervention to improve tamoxifen adherence in breast cancer survivors using an Intervention Mapping framework. Supportive Care in Cancer. 2020;29:3329\u0026ndash;38.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBhandari S, Ngo P, Kute B, Mandadi M, Pitman WA, Wu X, et al. Adherence to anti-estrogen therapy in women with hormone receptor-positive breast cancer utilizing bubble packaging: a pilot study. Breast Cancer Research and Treatment. 2019;177(2):395\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLabont\u0026eacute; M, Guillaumie L, Dionne A, Dorval M, Nabi H, Lemieux J, et al. Development of a community pharmacy-based intervention to enhance adherence to adjuvant endocrine therapy among breast cancer survivors guided by the Intervention Mapping approach. Research in Social and Administrative Pharmacy. 2020;16(12):1724\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGetachew S, Addisse A, Taylor L, Kantelhardt EJ. Improving Access and Adherence to Endocrine Therapy With Nurse-Based Intervention. Journal of Global Oncology. 2018;4(3):15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFink AK, Gurwitz J, Rakowski W, Guadagnoli E, Silliman RA. Patient Beliefs and Tamoxifen Discontinuance in Older Women With Estrogen Receptor\u0026mdash;Positive Breast Cancer. Journal of Clinical Oncology. 2004;22(16):3309\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJacob Arriola KR, Mason TA, Bannon KA, Holmes C, Powell CL, Horne K, et al. Modifiable risk factors for adherence to adjuvant endocrine therapy among breast cancer patients. Patient Education and Counseling. 2014;95(1):98\u0026ndash;103.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePhillips LA, Cohen J, Burns E, Abrams J, Renninger S. Self-management of chronic illness: the role of 'habit' versus reflective factors in exercise and medication adherence. J Behav Med. 2016;39(6):1076\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGardner B, Lally P. Modelling habit formation and its determinants. The psychology of habit. 2018:207\u0026ndash;29.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDanner UN, Aarts H, De Vries NK. Habit Formation and Multiple Means to Goal Attainment: Repeated Retrieval of Target Means Causes Inhibited Access to Competitors. Personality and Social Psychology Bulletin. 2007;33(10):1367\u0026ndash;79.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGardner B, Lally P, Wardle J. Making health habitual: the psychology of \u0026lsquo;habit-formation\u0026rsquo; and general practice. British Journal of General Practice. 2012;62(605):664\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLally P, Gardner B. Promoting habit formation. Health psychology review. 2013;7(1):137\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLally P, Van Jaarsveld CH, Potts HW, Wardle J. How are habits formed: Modelling habit formation in the real world. European journal of social psychology. 2010;40(6):998\u0026ndash;1009.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGardner B, Rebar A, Lally P. Habit Interventions. In: M. Hagger, L. Cameron, K. Hamilton, N. Hankonen, Lintunen T, editors. The Handbook of Behaviour Change. Cambridge: Cambridge University; 2020. p. pp.\u0026nbsp;599\u0026ndash;616.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarey RN, Connell LE, Johnston M, Rothman AJ, De Bruin M, Kelly MP, et al. Behavior change techniques and their mechanisms of action: a synthesis of links described in published intervention literature. Annals of Behavioral Medicine. 2019;53(8):693\u0026ndash;707.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMorrissey EC, Corbett TK, Walsh JC, Molloy GJ. Behavior change techniques in apps for medication adherence: a content analysis. American journal of preventive medicine. 2016;50(5):e143-e6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eThakkar J, Kurup R, Laba T-L, Santo K, Thiagalingam A, Rodgers A, et al. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease. JAMA Internal Medicine. 2016;176(3):340.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFinitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PloS one. 2014;9(2):e88166.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFree C, Phillips G, Galli L, Watson L, Felix L, Edwards P, et al. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS med. 2013;10(1):e1001362.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVervloet M, Linn AJ, van Weert JCM, de Bakker DH, Bouvy ML, van Dijk L. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc. 2012;19(5):696\u0026ndash;704.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, De Walque D, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS (London, England). 2011;25(6):825.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRottman BM, Marcum ZA, Thorpe CT, Gellad WF. Medication adherence as a learning process: insights from cognitive psychology. Health Psychology Review. 2017;11(1):17\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVon Blanckenburg P, Schuricht F, Albert U-S, Rief W, Nestoriuc Y. Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial. BMC Cancer. 2013;13(1):426.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHorne R, Weinman J. Self-regulation and Self-management in Asthma: Exploring The Role of Illness Perceptions and Treatment Beliefs in Explaining Non-adherence to Preventer Medication. Psychology \u0026amp; Health. 2002;17(1):17\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLeventhal H, Diefenbach M, Leventhal EA. Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cognitive therapy and research. 1992;16(2):143\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBingel U, Team FtPC. Avoiding Nocebo Effects to Optimize Treatment Outcome. JAMA. 2014;312(7):693\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWebster RK, Weinman J, Rubin GJ. How does the side-effect information in patient information leaflets influence peoples\u0026rsquo; side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England. Health Expectations. 2017;20(6):1411\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWebster RK, Rubin GJ. Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions. Frontiers in Psychiatry. 2019;9:775.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGraham CD, Gouick J, Krah\u0026eacute; C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clinical Psychology Review. 2016;46:46\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, et al. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. Journal of Clinical Oncology. 2021;39(31):3473\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHann KEJ, McCracken LM. A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science. 2014;3(4):217\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. European Journal of Cancer Care. 2015;24(1):15\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHulbert-Williams NJ, Storey L. Psychological flexibility correlates with patient-reported outcomes independent of clinical or sociodemographic characteristics. Supportive Care in Cancer. 2016;24(6):2513\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFeros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psycho-Oncology. 2011;22(2):459\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMosher CE, Secinti E, Li R, Hirsh AT, Bricker J, Miller KD, et al. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial. Supportive Care in Cancer. 2018;26(6):1993\u0026ndash;2004.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and Commitment Therapy: Model, processes and outcomes. Behaviour Research and Therapy. 2006;44(1):1\u0026ndash;25.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGonz\u0026aacute;lez-Fern\u0026aacute;ndez S, Fern\u0026aacute;ndez-Rodr\u0026iacute;guez C, Mota-Alonso MJ, Garc\u0026iacute;a-Teijido P, Pedrosa I, P\u0026eacute;rez-\u0026Aacute;lvarez M. Emotional state and psychological flexibility in breast cancer survivors. European Journal of Oncology Nursing. 2017;30:75\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFernandes-James C, Graham CD, Batterham AM, Harrison SL. Association of psychological flexibility with engagement in pulmonary rehabilitation following an acute exacerbation of chronic obstructive pulmonary disease. Chronic Respiratory Disease. 2019;16:147997311988089.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarrison A, Scott W, Timmins L, Graham CD, Harrison AM. Investigating the potentially important role of psychological flexibility in adherence to antiretroviral therapy in people living with HIV. AIDS Care. 2021;33(3):337\u0026ndash;46.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCheung K, Mak Y. Association between Psychological Flexibility and Health Beliefs in the Uptake of Influenza Vaccination among People with Chronic Respiratory Diseases in Hong Kong. International Journal of Environmental Research and Public Health. 2016;13(2):155.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGraham CD, McCracken LM, Harrison A, Walburn J, Weinman J. Outlining an Acceptance and Commitment Therapy approach to treatment non-adherence. British Journal of Health Psychology. 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHall LH, King N, Graham CD, Green SM, Barber A, Neal RD, et al. Strategies to self-manage side-effects of adjuvant endocrine therapy among breast cancer survivors: an umbrella review of empirical evidence and clinical guidelines. Journal of Cancer Survivorship. In Press.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeate M, Saunders C, Cohen P, Hickey M. Who is managing menopausal symptoms, sexual problems, mood and sleep disturbance after breast cancer and is it working? Findings from a large community-based survey of breast cancer survivors. Breast Cancer Research and Treatment. 2021;187(2):427\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLambert LK, Balneaves LG, Howard AF, Chia SLK, Gotay CC. Healthcare Provider Perspectives on Adherence to Adjuvant Endocrine Therapy after Breast Cancer. Current Oncology. 2021;28(2):1472\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348(mar07 3):g1687-g.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBartlett YK, Farmer A, Rea R, French DP. Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies. Journal of Medical Internet Research. 2020;22(5):e15989.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBartlett YK, Kenning C, Crosland J, Newhouse N, Miles LM, Williams V, et al. Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes. BMC Health Services Research. 2021;21(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBartlett YK, Farmer AJ, French DP. Does a text message intervention to support medication adherence in type 2 diabetes produce changes in hypothesised mediating variables, and what does change in these variables mean for medication adherence? JMIR Formative Research. In Press.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGardner B, Sheals K, Wardle J, McGowan L. Putting habit into practice, and practice into habit: a process evaluation and exploration of the acceptability of a habit-based dietary behaviour change intervention. International Journal of Behavioral Nutrition and Physical Activity. 2014;11(1):1\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAli EE, Cheung KL, Lee CP, Leow JL, Yap KY-L, Chew L. Prevalence and determinants of adherence to oral adjuvant endocrine therapy among breast cancer patients in Singapore. Asia-Pacific journal of oncology nursing. 2017;4(4):283.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMHRA. Best practice guidance on patient information leaflets. 2014.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRose MR, Norton S, Vari C, Edwards V, McCracken L, Graham CD, et al. Acceptance and Commitment Therapy for Muscle Disease (ACTMus): protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases. BMJ Open. 2018;8(10):e022083.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarris R. ACT Minfully 2021 [Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://libanswers.liverpool.ac.uk/faq/49511#:~:text=Adding%20\u003c/span\u003e\u003c/span\u003ea%20website%20as%20a,Type%20to%20'Web%20Page'.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcGregor LM, Von Wagner C, Vart G, Yuen WC, Raine R, Wardle J, et al. The impact of supplementary narrative-based information on colorectal cancer screening beliefs and intention. BMC Cancer. 2015;15(1):1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBennett KF, Von Wagner C, Robb KA. Supplementing factual information with patient narratives in the cancer screening context: a qualitative study of acceptability and preferences. Health Expectations. 2015;18(6):2032\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eClark DM. Realizing the Mass Public Benefit of Evidence-Based Psychological Therapies: The IAPT Program. Annual Review of Clinical Psychology. 2018;14(1):159\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM, Dziak JJ, Li R. Design of experiments with multiple independent variables: a resource management perspective on complete and reduced factorial designs. Psychological methods. 2009;14(3):202\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHorne R, Chapman SCE, Parham R, Freemantle N, Forbes A, Cooper V. Understanding Patients\u0026rsquo; Adherence-Related Beliefs about Medicines Prescribed for Long-Term Conditions: A Meta-Analytic Review of the Necessity-Concerns Framework. PLoS ONE. 2013;8(12):e80633.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJohns SA, Stutz PV, Talib TL, Cohee AA, Beck-Coon KA, Brown LF, et al. Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3‐arm pilot randomized controlled trial. Cancer. 2020;126(1):211\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarrow A, Dryden R, McCowan C, Radley A, Parsons M, Thompson AM, et al. A hard pill to swallow: a qualitative study of women's experiences of adjuvant endocrine therapy for breast cancer. BMJ Open. 2014;4(6):e005285-e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLewson AB, Johns SA, Krueger E, Chinh K, Kidwell KM, Mosher CE. Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. Supportive Care in Cancer. 2021;29(7):3487\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuastaferro K, Collins LM. Achieving the Goals of Translational Science in Public Health Intervention Research: The Multiphase Optimization Strategy (MOST). American Journal of Public Health. 2019;109(S2):S128-S9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCollins LM, Chakraborty B, Murphy SA, Strecher V. Comparison of a phased experimental approach and a single randomized clinical trial for developing multicomponent behavioral interventions. Clinical Trials. 2009;6(1):5\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNahum-Shani I, Dziak JJ. Multilevel Factorial Designs in Intervention Development. In: Collins LM, Kugler KC, editors. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: Advanced Topics. Cham: Springer International Publishing; 2018. p.\u0026nbsp;47\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSmith SG, Ellison R, Hall LH, Clark J, Hartley S, Mason E, et al. Acceptance and Commitment Therapy to Support Medication Decision-making and Quality of Life in Women With Breast Cancer: Protocol for a Pilot Randomised Controlled Trial, 12 July 2021, PREPRINT (Version 1) available at Research Square [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.21203/rs.3.rs-679400/v1]\u003c/span\u003e\u003c/span\u003e. 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychology Review. 2021;15(1):159\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWalburn J, Sainsbury K, Foster L, Weinman J, Morgan M, Norton S, et al. Why? What? How? Using an Intervention Mapping approach to develop a personalised intervention to improve adherence to photoprotection in patients with Xeroderma Pigmentosum. Health Psychology and Behavioral Medicine. 2020;8(1):475\u0026ndash;500.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Adapted Intervention mapping framework\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"643\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eTask\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eWhat was done?\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 1- Needs assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eConduct a needs assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eLiterature review of the problem of non-adherence, barriers to adherence, and existing interventions to support adherence to AET\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eDescribe the context for the intervention including population\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003ePopulation of interest described\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eState intervention goals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eOverall goal for the intervention established\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 2- Intervention objectives\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eDecide on behavioural determinants to be targeted\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eSelection of behavioural determinants based on needs assessment and context of intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eSpecify intervention component objectives for behavioural outcomes\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eIntervention component objectives stated\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eCreate a conceptual model\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eConceptual model created, detailing causal change pathways and hypothesised interactions between components\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 3- Intervention Design\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eChoose theory and evidence-based change methods\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eTheories relevant to each determinant identified were considered\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eSelect or design practical applications to deliver change methods\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eExisting interventions explored, informed by the needs assessment and practical applications considered\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 4- Intervention development\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eEstablish the format of the intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eIntervention components finalized based on stage 3\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eCreate intervention materials; draft and refine materials\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eIntervention development work completed\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eRefine intervention materials\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eStakeholder input from clinicians, patients and research team\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 5- Implementation planning\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eConsider how the intervention will be implemented\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eImplementations in the development phase discussed, and MOST optimization criterion outlined\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003eStage 6- Evaluation plan\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003ePrepare process evaluation questions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eProcess evaluation planned\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eDevelop indicators and measures for assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eAssessment measures decided on\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eSpecify the plans for evaluation design\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eOptimization plan considered\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003eComplete the evaluation plan\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003eProgress of evaluation stated\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"18.506998444790046%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.27993779160187%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOutline expected interactions between intervention components\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"41.21306376360809%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eHypothesised interactions between intervention components outlined and explained\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eKey: MOST = Multiphase Optimisation Strateg\u0026nbsp;\u003c/p\u003e\n\u003cp id=\"isPasted\"\u003eTable\u0026nbsp;2. Summary of barriers to AET adherence.\u003c/p\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"624\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eFactor associated with adherence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eExplanation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003eEvidence\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eExperience of side effects\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eBarrier: Increased frequency and intensity of side effects\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(11, 18, 20, 34, 37-40, 50-53)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eMedication beliefs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eFacilitator: more beliefs about the necessity of AET\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBarrier: more concerns about AET\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(11, 18-20, 32, 34-36, 38, 40).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eIllness perceptions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eFacilitators: beliefs that certain lifestyle behaviours can cause a recurrence\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBarriers: low risk perception of recurrence, high tamoxifen consequences, belief that psychological factors cause a recurrence\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(51, 52, 54)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eKnowledge/ information available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eBarriers: Lack of knowledge of side effects and the mechanisms of AET\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(34).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003ePsychological distress\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eBarriers: Increased distress (including depression and anxiety)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(20, 55).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eForgetfulness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eBarriers: forgetting to take medication, memory difficulties\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(18, 36, 56)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eSocial support\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eFacilitators: Increased social support\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(11, 32, 34, 35, 37, 38, 52).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003eSelf-efficacy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eFacilitators: Increased self-efficacy\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(32, 34, 38, 40)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"22.115384615384617%\"\u003e\n \u003cp\u003ePatient-physician communication\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"52.083333333333336%\"\u003e\n \u003cp\u003eFacilitators: Better patient-physician relationship\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.80128205128205%\"\u003e\n \u003cp\u003e(20, 32, 35, 37, 38)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eKey: AET = adjuvant endocrine therapy\u003c/p\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"926\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" width=\"100%\"\u003e\n \u003cp\u003eTable 3. Existing interventions supporting adherence to AET in women with breast cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAuthors\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDescription of Intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention modality\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAET type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003e\u003cstrong\u003eKey results (adherence related outcomes)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTheory that informed the intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eEll et al., (2009)(69)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eWritten information plus structured \u0026lsquo;patient navigation\u0026rsquo; phone interviews consisting of education, addressing barriers to adherence, problem solving, self-management support and emotional support.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information and telephone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAll\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003e2 arm RCT- enhanced usual care (information) vs written information plus patient navigation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference; 67% vs 69% (p=0.80).\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eHealth Belief model and socio-cultural explanatory theory\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eYu et al., (2012) (70)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003ePACT materials used. Patient education (welcome pack and quarterly newsletters) with information about breast cancer and adherence. Follow up reminder calls.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information and telephone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAnastrozole or letrozole\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eProspective, multicentre controlled observational study\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference; 95.9% vs 95.8% one-year persistence rate (p=0.95).\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone reported\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eZiller et al., (2013) (71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eCOMPAS study.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eLetter group: 8 personalized motivational reminder letters were sent over 2 years with information on topics side effects and treatment. A breast cancer information leaflet containing information on topics such as nutrition and sport. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eReminder phone calls: 8 telephone calls over 2 years which used motivational interviewing to address any questions, challenges to adherence, provide information and reminders.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information/ telephone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003e3 arm RCT- usual care vs letters vs telephone calls\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference in adherence in primary analysis. In post hoc analysis when pooling the intervention arms, adherence increased significantly in the intervention arms vs control (p=0.039). \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eLearning theory\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eHadji et al., (2013) (72)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003ePACT Program: educational materials sent to participants (9 mailed letters and brochures), monthly reminders on persistence to endocrine therapy, gift items sent e.g. 7 day tablet box, pocket mirror. Educational materials included information on relevant issues such as side effects, efficacy, nutrition, communication.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAnastrozole\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eRCT- usual care vs written information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference in compliance at 12 months (p=0.81).\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eNeven et al., (2014) (73)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eCARIATIDE program. PACT materials used- welcome pack and 9 letters and brochures mailed out, containing information on side effects, exercise, diet, communication.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eRandomized, parallel group observational study; usual care vs intervention\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference in compliance between arms at 12 months (p=0.4524). In Finland/Sweden, compliance was significantly higher in the intervention arm (p=0.0246). \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eGraetz et al., (2018) (75)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eApp: Web based app in which participants asked to record symptoms and report adherence in the past 7 days. Alerts sent to care team for any concerns.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eApp+ reminder: Web based app in which participants asked to record symptoms and report adherence in the past 7 days. Alerts sent to care team for any concerns. Weekly reminders sent to use the app via text or email.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eApp and text or email\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003ePilot RCT- app use only vs app use plus reminders to use app\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eProportion of patients adherent in the experimental group (100%) was greater than control group (72.7%); p\u0026lt;0.05.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eHeisig et al., (2015) (79)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eEnhanced information leaflet and 15-minute phone calls sessions including information on the mechanisms of AET, benefits and side effects.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information and telephone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAny\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eInterventional single cohort study\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eGreater adherence observed at 3‐month follow‐up.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eMarkopoulas et al., (2015) (74)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003ePACT materials. Educational materials sent to participants 9 times in one year, consisting of information on side effects, communication, sport, nutrition, benefits, tips on how to take AET. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAnastrozole or letrozole\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eRCT- standard care vs intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference in compliance or persistence between the groups at 12 months.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eCastaldi et al., (2017) (80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003ePatient navigation program. Initial visit include assessment of barriers to adherence. Navigator provides reminder calls prior to follow up appointments, meets patients at outpatient appointments and on day of surgery, and a financial consultation where required.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003ePatient navigation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eTamoxifen and AI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eNon randomized, historical care vs navigated care\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003e68.6% adherence in standard care vs 100% in patient navigation (p\u0026lt;0.0001).\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eHershman et al., (2020) (76)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eSMS messages sent twice weekly over 36 months. Content included overcoming barriers to medication adherence, cues to action, statements related to medication efficacy and reinforcements of the recommendation to take the medication. 40 messages repeated over intervention.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eText messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eRCT; text messages vs no text messages\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eNo significant difference between text messages (55.55%) and no text messages (55.4%) at 36 months.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eMoon et al., (2019) (81, 82)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eSelf-directed paper booklet designed in line with CBT and behaviour change theory. Included sections to modify beliefs about recurrence and the medication, to help manage side effects and to increase perceived behavioural control.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eWritten information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eTamoxifen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003ePilot trial; no control group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003ePrimary outcomes were feasibility and retention. Change from 100% to 91% who were non adherent after intervention. D=0.31 for improvement of unintentionally non adherent women.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eCommon sense model and theory of planned behaviour\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eBhandari et al., (2019) (83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003ePrescriptions given in a 30-day bubble pack with labelled day of the week; dispensed as 1- or 3-month supply.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eMedication packaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eTamoxifen and AI\u0026rsquo;s\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eSingle arm prospective investigational pilot study\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eSuggestion of improved adherence with bubble packaging (no control arm)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eTan et al., (2020) (77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eWeekly SMS reminders sent on a Monday morning reading \u0026quot;Mdm \u0026lt;NAME\u0026gt; please be reminded to take your anti-cancer medicine as instructed by your doctor. Take one tablet once every day.\u0026quot;.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eText messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAll\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eOpen level, multi centre prospective RCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eHigher percentage of adherence in SMS (72.4%) vs standard care (59.5%) at 6 months (p=0.034), but not at one year (p=0.617). \u0026nbsp; \u0026nbsp; No difference in serum hormone levels.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eKrok-Schoen et al., (2019) (78)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eDaily text message reminders focusing on initiation, continuation and adherence to prescribed dose; 14 messages repeated. Dynamic intervention in which participants complete weekly surveys on an app. Participants received feedback based on survey responses; either encouraging messages or problem solving. Physicians notified and patient has option to leave voice message and share with physician.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eText messaging and app\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eTamoxifen or AI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003ePilot trial; no control group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eSignificant improvement for self-reported medication adherence (p=0.015), significant decreases in oestradiol, oestrogen and estrone hormone levels (p\u0026lt;0.001).\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eLabonte et al., (2020) (84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eCommunity based pharmacy intervention; motivational interviewing given by pharmacists in brief individual consultations. Discussions focused on mode of action of AET, side effect coping and benefits of the medication.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eIn person (pharmacist)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eAll\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eIntervention mapping development\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eN/A- development paper\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eTheory of planned behaviour, motivational interviewing\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.907127429805616%\"\u003e\n \u003cp\u003eGetachew et al., (2018) (85)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"25.377969762419006%\"\u003e\n \u003cp\u003eBreast care nurses were trained as navigators to improve patient adherence in rural Ethiopia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.742980561555076%\"\u003e\n \u003cp\u003eBreast nurse navigators\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.043196544276459%\"\u003e\n \u003cp\u003eTamoxifen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.930885529157667%\"\u003e\n \u003cp\u003eRCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"16.30669546436285%\"\u003e\n \u003cp\u003eN/A- protocol abstract only\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.691144708423327%\"\u003e\n \u003cp\u003eNone mentioned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eKey: RCT= Randomised Control Trial; PACT= Patients Anastrozole Compliance to Therapy; COMPAS = Compliance in Adjuvant treatment of primary breast cancer Study; CARIATIDE = Compliance of Aromatase Inhibitors Assessment in daily practice through educational approach. AET = adjuvant endocrine therapy; SMS = short messaging service; CBT = cognitive behavioural therapy; AI = aromatase inhibitor.\u003c/p\u003e\n\u003cp\u003eTable 4. Registered clinical trials of interventions to support adjuvant endocrine therapy in breast cancer patients\u003c/p\u003e\n\u003cdiv align=\"center\"\u003e\n \u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"1011\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinical Trial ID\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDescription of intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention modality\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePopulation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003e\u003cstrong\u003eStatus\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" width=\"10.57312252964427%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdherence related outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT03592771\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eWeb-enabled app in which patients input their treatment-related symptoms or changes. Reported symptoms integrate into electronic health care records. Concerning symptoms trigger an alert to the care team and contact is made.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eApp group: receive weekly reminders (via text or email) to use the app\u003c/p\u003e\n \u003cp\u003eApp + Feedback group: receive weekly reminders and feedback about their use of the app\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eApp and text/email reminders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003e3 arm RCT; usual care vs app vs app plus feedback\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAI or Tamoxifen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eElectronic pillbox monitoring\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04142476\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eMotivational, semi-directed interviews with pharmacists over 18 months, to motivate adherence to hormone therapy. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eIn person\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eNo randomization; Single group assignment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eData from electronic pillboxes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04861896\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eSmartphone app with a 12-week program regarding psychoeducation about breast cancer and hormone therapy, stress awareness and management, social support, and enhanced communication and intimacy skills.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eApp\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eNo randomization; single group assignment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eHispanic/Latina women, any AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting (for pilot trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eAdherence to Refills and Medications Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04824339\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e8 week aerobic and resistance program with virtual group based supervised exercise sessions twice per week (60 minutes). Optional information on healthy eating.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eVirtual exercise sessions via Zoom\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRandomized, partial crossover; immediate intervention vs delayed intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eTamoxifen or AI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eVoils DOSE nonadherence measure (secondary outcome)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04651452\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eValues affirmation group: participants asked to write an essay monthly for 6 months about values important to them.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eReflective journal group: Participants will be asked to write monthly essays for 6 months about their daily routines, and values not important to them that could be important to others.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eOnline website or postal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; value affirmation vs reflective journaling\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eMorisky measure of adherence, and electronic pill bottle monitoring\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04719455\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eHCP visits; baseline visit will include motivation, collaborative goal setting and plans for adherence and physical activity. Follow ups with HCP include personalized visual reports of medication intake, number of steps, and to identify any problems and solutions.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eIn person\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003ePilot RCT; usual care vs self-management intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting (for pilot trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eNumber of days of missed medication (adherence is a secondary outcome)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04176809\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eOne compulsory workshop about AET benefits. 2 optional workshops about nutrition and fatigue monthly. Monthly reminder letters sent including tips to deal with side effects. Regular HRQoL assessments using a tablet before consultations.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eIn person, and letters\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; standard care vs routine HRQoL assessment and therapeutic information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eNot yet recruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eMorisky Green Levine scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04554927\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eWeb based application (no further information provided)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eApp\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; Web application vs active comparator (personalized schedule of medical follow up)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eMorisky 8 item adherence scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT04086875\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eTwice weekly SMS messages providing educational information for 6 months to motivate adherence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eText messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; usual care vs text messages\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eSmart pill bottles opening data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT02883361\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eMotivational enhancement therapy. 4 in person counselling sessions over 12 months. Motivational interviewing to increase motivation and decrease ambivalence about change.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eIn person\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; Motivational interviewing vs attention control\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eNot yet recruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eMedication possession ration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eCN-01810939\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eBreast cancer information leaflet. Personalized letter to remind, motivate and inform patients about AET. Additional reminder phone calls from a study nurse.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003ePost, phone calls\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003e3 arm RCT; standard information vs personalized letters telephone calls\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eNo information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eNo information\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eSelf-report and prescription refill\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT03949270\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eDaily text messages asking whether the patient has taken their medication, Weekly messages asking about side effects. Monthly messages asking about barriers to adherence. Contact from physician if there are any concerning responses.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eText messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; usual care vs text messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003ePersistence to therapy at one year\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT02707471\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eSelf-management intervention. 10 calls over 6 months delivered by a nurse, and tailored interactive voice messages based on adherence data. Focus on strategies for managing side effects, behavioural strategies to improve adherence and education.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003ePhone calls\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; self-management intervention vs general health education control\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eSmart pill bottles (bottle opening and percent of pills remaining)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT02850939\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eInteractive smartphone app that was personalized and culturally tailored. Additional support from a patient navigator. Focus on patient education, reporting side effects, delivery of self care advice, simplified communication between patient and oncology team.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eApp and patient navigation\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; usual care vs app and patient navigation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003ePrescribing and refill records and self-report data via mobile app.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10.17786561264822%\"\u003e\n \u003cp\u003eNCT03837496\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e6 weekly one hour sessions in small groups of 2-3; psychoeducation, problem solving barriers to adherence, cognitive behavioural skills, relaxation training, coping strategies for side effects, and mindfulness techniques. Two individual 15 minute semi-structured interview with therapist one and two months after the intervention to problem solve ongoing challenges with adherence.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.537549407114625%\"\u003e\n \u003cp\u003eVideoconferencing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.82213438735178%\"\u003e\n \u003cp\u003eRCT; STRIDE intervention vs medication monitoring control (pilot trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.363636363636363%\"\u003e\n \u003cp\u003eAny AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.090909090909092%\"\u003e\n \u003cp\u003eRecruiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.387351778656127%\"\u003e\n \u003cp\u003eMEMS caps, MARS-5 (adherence is secondary outcome due to pilot trial)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"1.1857707509881423%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eKey: RCT= Randomised Control Trial; AI = aromatase inhibitor; AET = adjuvant endocrine therapy; DOSE = Domains of Subjective extent of nonadherence; HCP = Health care practitioner; HRQoL = Health related quality of life; STRIDE = Symptom-targeted randomized intervention for distress and adherence to adjuvant endocrine therapy; MEMS = Medication event monitoring system; MARS-5; Medication adherence report scale.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNote: Where there were multiple publications regarding an ongoing trial (e.g. study protocols and development papers), the trial is only displayed in the ongoing interventions table to avoid repetition.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 5. Summary of intervention components to target determinants.\u003c/p\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"1040\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eDeterminant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.51923076923077%\"\u003e\n \u003cp\u003eIntervention component objective\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.173076923076923%\"\u003e\n \u003cp\u003eStrategy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eIntervention component\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"35.48076923076923%\"\u003e\n \u003cp\u003eDescription of intervention component\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.826923076923077%\"\u003e\n \u003cp\u003eBCT\u0026rsquo;s targeted\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eManagement of side effects\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.51923076923077%\"\u003e\n \u003cp\u003eIncrease ability to self-manage side effects\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eReduce impact of side effects\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.173076923076923%\"\u003e\n \u003cp\u003eInform patients of self-management strategies for common side effects\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eSelf-management website\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"35.48076923076923%\"\u003e\n \u003cp\u003eA website for self-management of side effects. Strategies to manage side effects with a summary of the strength of evidence for that side effect in a patient-friendly manner. Side effects included are arthralgia, fatigue, vulvovaginal symptoms, gastrointestinal symptoms, hot flushes and sleep difficulties.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.826923076923077%\"\u003e\n \u003cp\u003e1.2, 3.1, 3.3, 4.1, 5.1, 5.3, 5.6, 6.2, 6.3, 9.1, 11.1, 12.2, 12.5, 12.6\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eMedication and illness beliefs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.51923076923077%\"\u003e\n \u003cp\u003eIncrease beliefs about the necessity of using AET beliefs\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eReduce concerns about AET\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSupport formation of accurate illness perceptions\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.173076923076923%\"\u003e\n \u003cp\u003eProvide information on how AET works and the benefits of AET.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide information on the prevalence of side effects, answer common concerns about AET.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eProvide information on the mechanism of AET and the benefits of AET to enhance coherence, personal and treatment control\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eInformation Leaflet\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" width=\"35.48076923076923%\"\u003e\n \u003cp\u003eA written information leaflet with five different elements:\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003eAn explanation of how AET works, including medical diagrams\u003c/li\u003e\n \u003cli\u003eInformation and infographics about the benefits of AET\u003c/li\u003e\n \u003cli\u003eInformation about the prevalence of side effects from AET\u003c/li\u003e\n \u003cli\u003eAnswers to common concerns about AET\u003c/li\u003e\n \u003cli\u003eQuotes from breast cancer survivors about their experiences taking AET, and a statement highlighting that the leaflet was co-designed\u003c/li\u003e\n \u003c/ol\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eAs above\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.826923076923077%\"\u003e\n \u003cp\u003e1.2, 4.1, 4.3, 5.1, 5.2, 5.6, 6.2, 6.3, 9.1, 9.2, 11.2, 13.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.49925484351714%\"\u003e\n \u003cp\u003eKnowledge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.503725782414307%\"\u003e\n \u003cp\u003eLearn about AET, including how it works, the benefits and side effects of it\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"28.166915052160952%\"\u003e\n \u003cp\u003eProvide information about AET, it\u0026rsquo;s mechanism of action, benefits and side effect information\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"15.49925484351714%\"\u003e\n \u003cp\u003eInformation Leaflet\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.330849478390462%\"\u003e\n \u003cp\u003eAs above\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eForgetfulness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.51923076923077%\"\u003e\n \u003cp\u003eLearn strategies to remember to take AET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.173076923076923%\"\u003e\n \u003cp\u003eSupport the habit formation of daily medication taking and associated activities such as ordering and collecting prescriptions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eSMS messages\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"35.48076923076923%\"\u003e\n \u003cp\u003eSMS messages providing practical strategies to support taking medication regularly each day. Messages are sent in the following frequency:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\u0026middot; \u0026nbsp; \u0026nbsp; \u0026nbsp;2 weeks of daily messages\u003c/li\u003e\n \u003cli\u003e\u0026middot; \u0026nbsp; \u0026nbsp; \u0026nbsp;8 weeks of twice weekly messages\u003c/li\u003e\n \u003cli\u003e\u0026middot; \u0026nbsp; \u0026nbsp; \u0026nbsp;6 weeks of weekly messages\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.826923076923077%\"\u003e\n \u003cp\u003e1.2, 1.4*, 2.3*, 7.1*,\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7.3, 8.3*, 11.3, 12.1)*, 12.5)*\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003ePsychological distress\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"14.51923076923077%\"\u003e\n \u003cp\u003eReduce psychological distress\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.173076923076923%\"\u003e\n \u003cp\u003eIncrease psychological flexibility\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10%\"\u003e\n \u003cp\u003eACT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"35.48076923076923%\"\u003e\n \u003cp\u003eA guided-self help intervention based on ACT principles involving four skills:\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003eMindfulness:\u0026nbsp;broad awareness of the here-and-now.\u003c/li\u003e\n \u003cli\u003eUnhooking:\u0026nbsp;engaging and disengaging from thoughts as suits your purpose, and letting go of struggles with yourself.\u003c/li\u003e\n \u003cli\u003eFollow your values:\u0026nbsp;ongoing engagement with your values; consistently choosing to move in meaningful directions.\u003c/li\u003e\n \u003cli\u003eLiving beyond labels:\u0026nbsp;Taking a perspective beyond labels and responding to yourself in ways that help you grown and learn\u003c/li\u003e\n \u003c/ol\u003e\n \u003cp\u003eThe modules contain home practice tasks and are supported by individual sessions with a psychologist in the following format:\u003c/p\u003e\n \u003col\u003e\n \u003cli\u003e15 minute introduction\u003c/li\u003e\n \u003cli\u003e3x 25 minute sessions following modules 1, 2 and 3\u003c/li\u003e\n \u003cli\u003e15 minute closing session following module 4\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"11.826923076923077%\"\u003e\n \u003cp\u003e1.1, 1.2, 1.5, 1.6\u003csup\u003ea\u003c/sup\u003e, 1.7, 2.3,\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2.4, 3.1\u003csup\u003eb\u003c/sup\u003e, 4.1, 4.4, 5.2, 5.4, 5.6, 6.1, 6.2, 8.1, 8.2, 8.7, 9.1, 9.2, 10.9, 11.3, 11.4, 13.4, 15.2, 15.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eKey: BCT= Behavior change technique; AET = adjuvant endocrine therapy; SMS= short messaging service; ACT = Acceptance and commitment therapy.\u003c/p\u003e\n\u003cp\u003e*Refers to the BCT\u0026rsquo;s selected for messages to be based on during a one day workshop with behavior change experts.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ea\u0026nbsp;\u003c/sup\u003eNote: goals may be conceptualized differently in ACT (i.e. based on values) to how they are conceptualized in this taxonomy\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u0026nbsp;\u003c/sup\u003eNote: The definition of this BCT states \u0026ldquo;advise on, arrange or provide social support OR non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling\u0026rdquo;. The coding of this BCT reflects the encouragement provided as part of the support sessions. It does not reflect \u0026lsquo;non-contingent praise or reward for performance of the behaviour\u0026rsquo;, which is not consistent with an ACT approach.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1.1 Goal setting (behavior); 1.2 Problem solving; 1.4 \u0026nbsp;Action Planning; 1.5 Review behavior goals; 1.6 Discrepancy between current behavior and goal; 1.7 Review outcome goal(s); 2.3 Self-monitoring of behavior; 2.4 Self-monitoring of outcome(s) of behavior; 3.1 Social support (unspecified); 3.3 Social support (emotional); 4.1 Instruction on how to perform a behavior; 4.3 Re-attribution; 4.4 Behavioral Experiments; 5.1 Information about health consequences; 5. Salience of Consequences; 5.3 Information about social and environmental consequences; 5.4 Monitoring of emotional consequences; 5.6 Information about emotional consequences; 6.1 Demonstration of the behavior; 6.2 Social comparison; 6.3 Information about others\u0026rsquo; approval; 7.1 Prompts/cues; 7.3 Reduce prompts/cues; 8.1 Behavioral practice/ rehearsal; 8.2 Behavior substitution; 8.3 Habit Formation; 8.7; Graded tasks; 9.1 Credible source; 9.2 Pros and Cons; 10.9 \u0026nbsp;Self-reward; 11.1 Pharmacological support; 11.2 Reduce negative emotions; 11.3 Conserving mental resources; 11.4 Paradoxical Instructions; 12.1 Restructuring the physical environment; 12.2 Restructuring the social environment; 12.5 Adding objects to the environment (12.5); 12.6 Body changes; 13.2 Framing/ reframing; 13.4 Valued self-identity; 15.2 Mental rehearsal of successful performance; 15.3 Focus on past success\u003c/p\u003e\n\u003cp id=\"isPasted\"\u003eTable 6. Readability of intervention components.\u003c/p\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"529\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003eIntervention Component\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003eFlesch-Kincaid Grade\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003eAge range\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003eSMS messages\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e7.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e12-13 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003eInformation leaflet\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e7.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e12-13 years old\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003eACT participant manuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; Module 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e6.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e11-12 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; Module 2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e6.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e11-12 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; Module 3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e7.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e12-13 years old\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; Module 4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e8.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e13-14 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"44.6124763705104%\"\u003e\n \u003cp\u003eWebsite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"30.434782608695652%\"\u003e\n \u003cp\u003e7.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.95274102079395%\"\u003e\n \u003cp\u003e12-13 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eKey: SMS= short messaging service; ACT = Acceptance and commitment therapy.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"breast cancer, medication adherence, intervention mapping, multiphase optimisation strategy","lastPublishedDoi":"10.21203/rs.3.rs-1239166/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1239166/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAdjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003e Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 2\u003csup\u003e4\u0026minus;1\u003c/sup\u003e fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components and overall trial experience.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eWe have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.\u003c/p\u003e","manuscriptTitle":"Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-01-26 19:07:05","doi":"10.21203/rs.3.rs-1239166/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2022-03-31T11:36:39+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2022-03-08T15:54:58+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"ca693e02-3ec2-4220-b4b8-36b086ce2db7","date":"2022-03-05T00:02:17+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-03-04T23:45:39+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-03-04T19:58:11+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2022-02-24T16:42:15+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2022-02-24T16:39:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2022-01-07T15:59:55+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"67b52560-6850-4446-8375-f6981245f79e","owner":[],"postedDate":"January 26th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2022-06-21T06:29:25+00:00","versionOfRecord":[],"versionCreatedAt":"2022-01-26 19:07:05","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1239166","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1239166","identity":"rs-1239166","version":["v1"]},"buildId":"oE6Zbj460LM0Up2FdVbMZ","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}