Using Normalization Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: The STAMINA Lifestyle Intervention

Using Normalization Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: The STAMINA Lifestyle Intervention | 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 Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Using Normalization Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: The STAMINA Lifestyle Intervention Sophie Reale, Rebecca R Turner, Liz Steed, Steph J. C Taylor, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3867587/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Sep, 2024 Read the published version in Implementation Science Communications → Version 1 posted 5 You are reading this latest preprint version Abstract Background The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how implementation of NICE recommendations within a trial context was explored during complex intervention development to enable evaluation of a lifestyle intervention. Methods Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored strategies for embedding SLI into the context of the NHS with delivery partner Nuffield Health. Results Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of SLI and underpinning theory and evidence ( Coherence ). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge ( Cognitive participation ). Furthermore, a simple communication ( Collective Action ) and progress reporting system ( Reflexive Monitoring ) was suggested to fit into existing infrastructure within the NHS and community partner. Conclusions Application of NPT within two stakeholder workshops optimised complex intervention development. Context-specific strategies to support implementation of the STAMINA Lifestyle Intervention within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. Trial registration (ISRCTN: 46385239). Intervention Development Normalisation Process Theory Behaviour Change Prostate Cancer Exercise Lifestyle Stakeholders Complex intervention Process Evaluation Implementation Figures Figure 1 Figure 2 Contribution to Literature It takes on average 17 years for 14% of original research to be integrated into clinical practice. We demonstrate how implementation science and behavioural science theories and frameworks can be applied in parallel to optimise intervention development that might contribute to future implementation of complex interventions into the NHS and charity sector (i.e., Nuffield Health), in a time and resource efficient way. These findings address recognised gaps between research, policy, and practice by identifying acceptable and trial specific implementation strategies in aim of embedding supervised exercise into standard NHS prostate cancer care (if found to be clinically and cost effective). This file presents a description of the STAMINA Lifestyle Intervention in accordance with the TIDIeR framework. This file contains the topic guide that guided round table discussions at stakeholder workshop 1 and 2. The topic guide is based on the Normalisation Process Theory. This file contains feedback from stakeholders, in stakeholder workshop 1 and 2, mapped onto the Normalisation Process Theory framework. Background Supervised exercise is a safe and clinically efficacious solution to address the adverse effects of androgen deprivation therapy (ADT) for prostate cancer ( 1 ). Clinically meaningful improvements in fatigue and cancer specific quality of life are demonstrated following twelve weeks of supervised exercise and dietary support, with improvements being sustained up to 6-month follow-up ( 1 , 2 ). As such the National Institute for Health and Care Excellence (NICE; NG131 1.4.19) recommend that men with locally advanced and advanced prostate cancer on ADT should be offered supervised, aerobic and resistance exercise at least twice a week for 12 weeks ( 3 ). However, very few National Health Service (NHS) trusts have established adequate provision for such supervised services according to this recommendation ( 4 ). This deficit is emblematic of the barriers to translating and embedding high-quality evidence and national recommendations into complex healthcare systems. At present, it is estimated that less than half of all novel clinical innovations with proven efficacy are translated into routine healthcare ( 5 ). Furthermore, it takes a considerable length of time for research findings to influence policy and practice ( 6 ). Fortunately, significant recent advances in Implementation Science have yielded theories and frameworks that guide researchers towards embedding and evaluating interventions in real-world settings e.g., ( 7 ). As such, it is recommended that factors pertinent to the immediate and future implementation of interventions (i.e., within a trial and healthcare setting respectively) are explored early, during complex intervention development. Failure to consider implementation during intervention development and subsequent trial evaluation may slow or halt the uptake and translation of proven healthcare interventions into future routine care. Normalisation Process Theory (NPT) ( 8 ) was developed to overcome difficulties encountered when implementing complex behavioural interventions into healthcare practice. Recent guidance on intervention development and evaluation stress the importance of encompassing strong theoretical foundations and engaging diverse stakeholders at all stages ( 9 , 10 ). NPT is a mid-range theoretical model that can be applied at different stages of research to provide an explanatory framework to help understand how practices are or may be implemented, embedded, and integrated into routine practice ( 11 ). NPT suggests the implementation of an intervention is operationalised through four main constructs: understanding the way people make sense of the work of implementing and integrating an intervention individually and as a team ( construct 1: coherence ); how they engage with that intervention ( construct 2: cognitive participation ); how they enact it in day-to-day practice ( construct 3: collective action ); and how they appraise its effects ( construct 4: reflexive monitoring ). In this paper, we used the STAMINA complex intervention as an exemplar (Additional File 1) to discuss the application of NPT during complex intervention development to identify barriers, facilitators, and consider strategies for future implementation in the NHS. Methods Study context and approvals This study contributes to a National Institute for Health and Care Research (NIHR) funded Programme Grant for Applied Research (PGfAR) aiming to evaluate the clinical and cost-effectiveness of embedding a tailored lifestyle intervention for men with prostate cancer on ADT into NHS prostate cancer care with delivery partner Nuffield Health (ISRCTN: 46385239) (See Fig. 1). The STAMINA complex intervention was developed and refined in accordance with the Medical Research Council (MRC) guidance for the development of complex interventions ( 12 ). For more information see ( 13 , 14 ). This paper provides a detailed account of two stakeholder workshops underpinned by NPT and delivered during complex intervention development. Stakeholder workshop 1 (SW1) was held in February 2019 following a review of evidence and qualitative exploration of barriers and facilitators to the target behaviours. Stakeholder workshop 2 (SW2) was held in January 2020 ahead of the complex intervention being finalised and implemented in a pragmatic randomised controlled trial (RCT) (See Fig. 2). Figure 1: Overview of the STAMINA Programme Grant for Applied Research Figure 2: Contribution of two stakeholder workshops to the development and refinement of the STAMINA complex intervention Regulatory and ethical approvals were sought prior to the commencement of research activities from Sheffield Hallam University (Reference: ER10748795) and the NHS (REC reference: 18/NW/0738 / IRAS project ID: 254343). Written informed consent was collected from all participants prior to research activity. Participants and Materials The workshops brought together representatives from key stakeholder groups purposively sampled to include NHS healthcare professionals (HCPs) working in prostate cancer care, community-based exercise professionals (EPs), people with advanced prostate cancer and their families/ carers, behaviour change experts and researchers. The main aims of SW1 were to refine the intervention and address key uncertainties regarding its feasibility and acceptability when embedded into routine clinical care. SW2 was focussed on further intervention refinement - building iteratively on feedback from SW1 and qualitative intervention development work ( 13 , 14 ). SW2 also explored stakeholder opinions on the intervention materials (i.e., patient diary and information booklet), progress reporting systems and the communication pathway, with consideration to the implementation of STAMINA in day-to-day practice in both the NHS and charity sector (i.e., Nuffield Health). Procedure Workshop participants were allocated a group table comprised of representatives from all stakeholder groups for facilitated cross-group discussion ( 15 ) considering impacts across these groups. The format of both workshops included short explanatory presentations on various intervention elements by STAMINA research team members followed by task-based table discussions led by a facilitator (SR, RRT, ES, LS, ST, LB) and broad topic guide (Additional File 2). Each table discussion was followed by a facilitated (DM) whole group discussion as an opportunity for debate, sense checking and conclusion generation. Notes from the table and whole group discussions were written individually by table facilitators in workbooks and on flip-chart paper. Stakeholders were provided with feedback forms to complete at the end of the session. Moreover, written feedback was collated by table facilitators and the research team to produce a summary that was sent to all stakeholders who were then invited to send any further comments to the team via email. Analysis: To facilitate analysis of the stakeholder workshop discussions and feedback forms, we developed an analysis framework (ES) incorporating NPT constructs and sub-constructs and mapped our data onto this, paying attention to uncertainties across the different stakeholder groups and specific elements of the intervention (Table 1 ). We also considered data that fell outside of the NPT constructs and thus took an inductive and deductive approach to analysis ( 16 ). Table 1 Normalisation Process Theory Constructs and Sub-Constructs for the STAMINA programme Using Normalisation Process Theory in developing/refining the STAMINA intervention Core construct Sub-constructs 1. Coherence - Sense-making work that people do individually or collectively: understanding the purpose, value, and benefits of the STAMINA programme 1.1 Differentiation: how is STAMINA different from other interventions. 1.2 Communal Specification: building a shared understanding of aims, objectives, benefits of STAMINA. 1.3 Individual Specification: understanding specific tasks and responsibilities within STAMINA. 1.4 Internalization: understanding the value, benefits, importance of STAMINA. 2. Cognitive Participation - Relational work that people do to build and sustain a community of practice : getting buy-in, STAMINA champions. 2.1 Initiation: whether key participants are working to drive STAMINA implementation forward. 2.2 Enrolment: strategies used to engage (buy-in), sustain engagement, and help secure implementation. 2.3 Legitimation: ensuring participants believe it is right for them to be involved and they can make valid contribution. 2.4 Activation: collectively defining actions and procedures needed to sustain STAMINA. 3. Collective Action - Operational work that people do to enact a set of practices : how STAMINA works in day-to-day practice (including roles/resources), communication pathways 3.1 Interactional Workability: interactional work people do when operationalizing STAMINA. 3.2 Relational Integration: knowledge work to build accountability and maintain confidence in STAMINA. 3.3 Skill set workability: the allocation work that underpins the division of labour built up around STAMINA. 3.4 Contextual integration: managing STAMINA through allocation of resources, execution of protocols, policies, procedures. 4. Reflexive monitoring - Appraisal work people do to assess and understand the ways a new set of practices affect them and the others around them: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, EPs) or taking part (patients) in STAMINA 4.1 Systemization: collecting information to determine the effectiveness/utility of STAMINA. 4.2 Communal appraisal: participants working together to evaluate STAMINA. 4.3 Individual Appraisal: participants working experientially as individuals to appraise its effects on them and the contexts in which they are set. 4.4 Reconfiguration: redefining procedures or modifying practices within STAMINA. The analysis was led by a researcher with expertise in qualitative research and application of the NPT (ES). Data was cross-checked by two independent researchers (SR, RRT) and discussed where any inconsistencies were identified. Our findings were then used to inform and aid refinement of the STAMINA complex intervention ahead of examining its acceptability and feasibility when integrated into routine prostate cancer care in a feasibility study ( 17 ). INSERT Table : Normalisation Process Theory Constructs and Sub-Constructs for the STAMINA programme Results Stakeholder Workshop 1 Twenty-eight stakeholders attended SW1 (Table 2 ). Workshop participants discussed the content of the intervention and associated training packages, with a view to its potential integration into routine cancer care. We explored stakeholders’ perceptions of STAMINA across the four NPT constructs and sub-constructs to help understand perceived potential benefits of STAMINA for men with prostate cancer, in addition to factors impacting upon its implementation (Additional File 3). Table 2 a: Stakeholder workshop 1 attendees Stakeholder Number of attendees Patient and public involvement members 8 Nuffield Health senior staff 3 Nuffield Health Exercise Professionals 6 Academic and community exercise professionals 2 Health Economist 1 Health psychologist 1 CCG 3 Cancer alliance 1 Healthcare professionals (secondary care) 3 Total Number 28 Table 2 b: Stakeholder workshop 2 attendees Stakeholder Number of attendees Patient and public involvement members 4 Nuffield Health senior staff 3 Nuffield Health Exercise Professionals 1 Academic and community exercise professionals 2 Health psychologist 1 CCG 1 Healthcare professional (secondary care) 9 Research nurse (secondary care) 1 Healthcare professional (primary care) 3 Macmillan rehab lead 1 PCUK 2 Total Number 28 INSERT Table 2 : Stakeholder workshop attendees Table 2 a: Stakeholder workshop 1 attendees Table 2 b: Stakeholder workshop 2 attendees Coherence: understanding the purpose, value, and benefits of the STAMINA programme Within NPT the embedding of a practice (normalization) is made possible by “a set of ideas about its meaning, uses, and utility; and by socially defined and organized competencies”( 8 ) (p542) which hold the practice together. In discussions, stakeholders recognised the importance of highlighting STAMINA’s unique selling points in professional training and patient-facing materials - including how the intervention is tailored to address individual needs (differentiation). Further key factors were ensuring that all stakeholders were made aware of the evidence base in support of the intervention (communal specification); that HCPs and EPs understood their individual roles and responsibilities within STAMINA (individual specification); and that patient-facing materials (such as STAMINA information booklets) should highlight the supportive evidence base, illustrated by patient stories, pictures and quotes. Together these factors were seen to make the practice “meaningful”, for example increasing HCP’s confidence in referring patients to the STAMINA Lifestyle Intervention (Additional file 3). Cognitive participation: getting buy-in, STAMINA champions This construct explores the “symbolic and real enrolments and engagements of human actors” ( 8 ) (p 243) that enable them to work together to build and sustain a community of practice. It was important to explore participants opinions on the possibility for the introduction of STAMINA in routine prostate cancer care – would HCPs and EPs be prepared to invest time and resource into getting STAMINA up and running ( 11 ), and would men with prostate cancer on ADT be keen to participate? To facilitate HCP and EP buy-in, stakeholders highlighted the importance of enrolling STAMINA “champions” located in both the NHS and Nuffield Health to engender confidence in the intervention (enrolment) and that training would need to be flexible with advanced notice to fit in with existing roles and commitments (initiation, enrolment). It was also highlighted that demonstrating the expertise of Nuffield Health in delivering exercise programmes to clinical populations (e.g., cystic fibrosis, joint pain) and their charitable status would be key to gaining trust in the intervention (legitimation) (Additional file 3). Collective Action: how STAMINA works in day-to-day practice (including roles/resources), communication pathways This construct considers how actors work collectively towards specific goals as part of a particular practice ( 8 ). Discussions focussed largely on early stages of implementation, for example, enabling HCPs and EPs to complete related training packages by offering different modes of deliveries (e.g., face-to-face versus remote) and hosting them on internal systems (interactional workability, contextual integration). Stakeholders also identified a need for an established referral and communication pathway, particularly in relation to assessing patient eligibility for participation and clear processes for raising concerns (relational integration; contextual integration). Furthermore, there were discussions about the current and required skillset of different roles within the fitness and wellbeing industry (e.g., physiologists, physiotherapists, and personal trainers) to identify the most suitable role and subsequent training needs to deliver the STAMINA programme – with a particular focus on having the skills and confidence to tailor exercise for men with prostate cancer who often have a number of health comorbidities (skill set workability) (Additional file 3). Reflexive monitoring: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, EPs) or taking part (patients) in STAMINA The final NPT core construct considers how actors work together to continuously evaluate the outcomes of a practice, and in turn how these impact on its potential for normalization ( 8 ). Discussions briefly touched on developing clear systems for clinical escalations in emergency scenarios (systemization); as well as methods of assessing the professional training packages (communal appraisal, individual appraisal); and adapting training materials and intervention documents (i.e., progress reports) to fit with existing technological systems (reconfiguration). Factors related to this construct were discussed more extensively in SW2 (Additional file 3). Intervention refinement following Stakeholder Workshop 1 Following feedback from stakeholders, the STAMINA complex intervention was refined to optimise the process of embedding supervised exercise into the prostate cancer care pathway ahead of a pragmatic RCT ( 8 ). Key changes included hosting high level training on Nuffield Health internal systems and mandating completion by all front of house staff, management, and sales teams to enhance awareness related to operational procedures. Moreover, the decision was made to upskill personal trainers to deliver and support patient exercise behaviour as their role within Nuffield Health more closely aligns with the requirements of delivering the STAMINA Lifestyle Intervention compared to that of a physiotherapist or physiologist. Information about Nuffield Health (e.g., charitable status, previous involvement in clinical research and exercise delivery, skillset, and mandatory training) was also added to the HCP training package and patient-facing materials alongside case study examples (quotes, patient stories, pictures etc.) to enhance understanding of the intervention purpose and subsequent buy-in. Stakeholder Workshop 2 Twenty-eight stakeholders attended SW2 (Table 2 ). We built on the feedback from SW1 to frame discussions on the refined intervention. Discussions focussed on further refinement; progress reporting; communication pathways; and involved detailed consideration of the integration of STAMINA in day-to-day practice in both the NHS and charitable sector. There were some brief discussions related to the NPT construct of Coherence , where participants re-emphasised the importance of STAMINA’s grounding in a supportive evidence-base and tailoring to fit individual patient’s needs to facilitate normalization (differentiation). Factors related to the construct of Cognitive Participation involved consideration of how the format of the patient facing materials might be refined to enhance acceptability of their use in the gym and prevent unwanted attention from the general public. It was also agreed that information about suitable clothing should be added so that men didn’t feel the need to invest in expensive kit (enrolment, legitimation) (Additional file 3). Collective Action: how STAMINA works in day-to-day practice (including roles/resources), communication pathways To implement STAMINA, key stakeholders need to work together to achieve common goals. Factors related to the construct Collective action were therefore discussed, including consideration of how HCPs and EPs might work together in the future to communicate key outcomes e.g., sharing patient progress with primary care staff (interactional workability). Specific roles and responsibilities in operationalizing the intervention were explored in detail, with a particular emphasis on streamlining progress reporting systems. Stakeholders also emphasised the role of the patient in taking ownership for recording their progress (skill set workability). The sub-construct of contextual integration focuses on how the introduction of a new practice affects “the mechanisms that link work to existing structures and procedures, and for realizing material and symbolic resources for them” ( 8 ) (p545). HCP and EP attendees highlighted the importance of introducing communication pathways and reporting systems that could integrate within existing systems and that they could easily incorporate within their day-to-day practice, and that these should be clearly set out in initial training packages (contextual integration). This included systems for reporting safety/health issues such as Nuffield Health’s internal Clinical Escalation policy and team (Additional file 3). Reflexive monitoring: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, CEPs) or taking part (patients) in STAMINA SW2 involved detailed discussion of factors related to the refinement of systems for collecting information to determine the utility/effectiveness of STAMINA (Additional File 3). There was lengthy consideration of the format, function, language/terminology, and purpose of the progress report e.g., that it should not act as safety reporting tool. Similarly, stakeholders proposed and agreed that the STAMINA diary should act as a self-monitoring tool to support patient behaviour change and maintenance and should be separate to the logbooks designed for data capture/ research purposes only (systemization). Leading on from this, stakeholders discussed how patients and EPs should use the report as a tool to aid discussions to evaluate progress (communal appraisal); and that patients should be provided with the opportunity to voice opinions on their personal progress e.g., within the STAMINA diary (individual appraisal). The latter factor linked to the NPT sub-construct of legitimation, in giving men confidence to participate. Possible enhancements to the patient facing materials were also discussed e.g., adding patient stories and photographs (reconfiguration). Intervention refinement following Stakeholder Workshop 2 Following SW2, the patient facing materials were refined to increase acceptability based on stakeholder recommendations. More specifically, i) the STAMINA diary was reduced from A4 to A5 and wire bound to increase usability, ii) all STAMINA logos were removed from the front and back cover and replaced with standard Nuffield Health branding to reduce the likelihood of patients ‘standing out’ and receiving subsequent unwanted special attention and iii) additional information was added to depict appropriate clothing for exercise to enhance inclusivity. Moreover, an email communication pathway, embedded into current internal systems and IT infrastructure was established for reporting/ escalating problems and discussing patient progress between Nuffield Health and the NHS. The method was chosen for its simplicity, safety (e.g., end-to-end encryption) and future proofing (e.g., likely to work in the future regardless of changes made to internal IT systems) (Additional file 3). Discussion This paper describes the first application of NPT to complex intervention for management of ADT side-effects in prostate cancer. Behaviour change theories ( 18 , 19 ) guided the early intervention development stages which were complemented by Implementation Science, i.e., NPT ( 8 ). Stakeholder feedback was captured during round-table discussions to enhance possibilities for normalization, as they “play an important part in feeding back into notions of the coherence and meaningfulness of a practice” ( 8 ). Discussions and analysis centred on NPT led to the optimisation of the STAMINA complex lifestyle intervention including patient facing materials and professional training packages. Moreover, consideration for individual roles and infrastructure within the specified contexts led to the identification of a clear and simple communication pathway to fit within the organisational structures of the NHS and the chosen delivery partner, Nuffield Health. At present, the provision of supervised exercise into the prostate cancer care pathway, as recommended by NICE, is rarely offered due to a multitude of barriers related to implementation ( 4 ). As described previously ( 20 ), NPT was used to identify barriers and facilitators related to practicalities of NHS delivery in a sequential fashion across the two workshops. In the early phases of intervention development (i.e., SW1), the constructs of Coherence and Cognitive Participation (and related sub-constructs) were of particular relevance in our analysis. All stakeholders identified ‘buy-in’ and a good understanding of the underpinning evidence in support of the intervention as a necessary precursor to its implementation. In particular, the introduction of STAMINA Champions, information about the charity sector and clarity on professional roles were collectively identified as mechanisms to increase HCP confidence to recommend and refer patients for exercise. Over the past decade, the use of champions has become a focal point of implementation research with systematic reviews evidencing champions as one of the core determinants of implementation success in healthcare settings ( 21 ). However, less is known about the use of champions in other contexts. In the present study, EPs agreed champions could be beneficial in the charity sector though greater emphasis was placed on which professionals should be trained to deliver the intervention and where the training was hosted as a strategy to enhance early ‘buy-in’. These differences highlight the importance of learning about the target contexts so that implementation strategies can be tailored accordingly (i.e., it is not a one size fits all). The NPT constructs Collective Action and Reflexive Monitoring (plus sub-constructs) were the main discussion points of SW2. Discussions were centred on how to operationalise the STAMINA Lifestyle Intervention into routine practice with consideration for future refinements ahead of delivery in the ever-changing context of the NHS and charity sector (Reconfiguration). For example, a simple and clear communication and reporting pathway between HCPs, EPs, and patients was favoured against a more complex reporting system that may require specialist software/ resource and may not be accessible to all contexts involved, now or in the future. Moreover, stakeholders agreed that intervention and research related information should be presented in separate materials to increase internal validity and so that minimal, if any, changes are required to the intervention materials ahead of national scale implementation (if found to be effective) – this is advantageous from both a resource and time perspective. Failure to address context specific changes could constitute a major barrier to appraising the transferability and applicability of findings following our planned RCT and may contribute to furthering the gap between research, policy, and practice ( 22 ). Instead, the workshops developed our understanding of the local contexts so that a modifiable intervention could be developed and evaluated in our process evaluation to enable future implementation in a timely fashion (if found to be effective). Strengths & Limitations Consideration of factors related to implementation as part of an iterative intervention development process was deemed essential for intervention optimisation ahead of testing in the context of a RCT. This blended approach is strengthened by its methodological rigour, time efficiency and likeliness of success compared to more traditional and sequential methods which tend to retrospectively explore implementation following intervention development and efficacy trials. Subsequently, the STAMINA Lifestyle Intervention was found to be feasible and acceptable, and delivered with moderate to high fidelity, when embedded into the NHS and Nuffield Health during a feasibility study ( 17 ). More specifically, delivering two stakeholder workshops at different phases of intervention development enabled the research team to sequentially explore the four constructs of NPT to identify theory-informed implementation strategies as the intervention evolved. Furthermore, offering two workshops enhanced stakeholder reach thus providing valuable insight into organisational specific information which has been found to increase the adoption, implementation, and sustainability of interventions ( 23 ). Subsequently, attendance at the workshops may have had additional implementation benefits beyond the primary aim focussing on the intervention. For example, workshop attendance may have acted as a mechanism to enhance coherence and cognitive participation and support delivery of the trial as most clinical stakeholders submitted an expression of interest for their NHS Trust to be involved in embedding supervised exercise into the NHS as part of the STAMINA RCT. Application of the NPT during intervention development enabled us to identify and characterise key mechanisms to facilitate implementation of the STAMINA Lifestyle Intervention and aid intervention development as part of an iterative process. However, in certain instances, application of the NPT was challenging as during the analysis phase some stakeholder feedback was mapped onto multiple constructs/sub-constructs demonstrating the multifaceted interactions of different elements of a complex intervention. For example, discussions around the format and purpose of the patient diary spanned the sub-constructs of legitimation and individual appraisal. Furthermore, the researchers who have a background in behaviour change had a natural desire to code discussion items onto the Theoretical Domains Framework (TDF). This may reflect the researcher’s familiarity with the behaviour change framework and/ or highlight that the TDF is also a tool designed to assess implementation and other behavioural problems to inform intervention design ( 18 ). Subsequently, we took an inductive and deductive approach to analysis and so both intervention and implementation barriers were explored in parallel to increase the usefulness and policy relevance of the research ( 24 ). If the STAMINA PGFaR is proven to be clinically and cost effective, future implementation work using NPT will be guided by the newly developed and published NPT coding manual – a tool created to provide a consistent and simple set of definitions of the core constructs of the theory to support researchers with qualitative analysis ( 25 ). Conclusions In this paper, we discuss the first application of NPT during complex intervention development and consider possible future implementation of embedding supervised exercise into routine clinical care. This blended approach demonstrates methodological rigour, time efficiency and increased likeliness of success compared to more traditional and sequential methods which tend to retrospectively explore implementation following intervention development and efficacy trials. All four constructs of the NPT were explored to identify context specific implementation strategies to address barriers and facilitators to ‘normalising’ processes of embedding new pathways of care into the NHS with delivery partner Nuffield Health. The NPT will provide the explanatory framework to help understand how the STAMINA complex intervention is implemented, embedded, and integrated into routine practice in a planned definitive RCT (Trial registration: ISRCTN: 46385239). Abbreviations EP Exercise Professional HCP Healthcare Professional MRC Medical Research Council NHS National Health Service NICE National Institute for Health and Care Excellence NIHR National Institute for Health and Care Research NPT Normalisation Process Theory PGfAR Programme Grant for applied research RCT Randomised Controlled Trial STAMINA Supported exercise TrAining for Men with prostate caNcer on Androgen deprivation therapy SW Stakeholder Workshop TDF Theoretical Domains Framework Declarations Ethical approval and consent to participate were sought prior to the commencement of research activities from Sheffield Hallam University (Reference: ER10748795) and the NHS (REC reference: 18/NW/0738 / IRAS project ID: 254343). Consent for publication – not applicable Availability of data and materials - All data generated or analysed during this study are included in this published article [and its supplementary information files]. Competing Interests – The authors declare no competing interests. Funding – This project is funded by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research (PGfAR) (Grant Reference Number RP-PG-1016-20007). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Author contributions: Conceptualization: LS, SJC; Methodology: SR, RT, ES, DM; Formal Analysis: ES, SR, RT; Writing-Original Draft Preparation: SR, ES; Writing-Review & Editing: SR, ES, RRT, SJC, LS, DR, LB, DM, AI; Funding Acquisition: DJR and LB. All authors read and approved the final manuscript. Acknowledgements - To participants, the PPI group, Nuffield Health, and STAMINA co-applicants. The STAMINA co-applicants include Tom Baker, Professor Janet Brown, Michelle Collinson, Professor Patrick Doherty, Professor Amanda Farrin, Professor Diana Greenfield*, Suzanne Hartley, Professor Jenny Hewison, Professor Malcom Mason, and Dr David Meads. Additional author information: * Diana Greenfield is a National Institute for Health Research (NIHR) Senior Nurse Research Leader. The views expressed in this article are those of the author and not necessarily those of the NIHR, or the Department of Health and Social Care. References Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, et al. Exercise for men with prostate cancer: A systematic review and meta-analysis. European Urology. Volume 69. Elsevier B.V.; 2016. pp. 693–703. Nguyen PL, Alibhai SMH, Basaria S, D’Amico AV, Kantoff PW, Keating NL, et al. Adverse effects of androgen deprivation therapy and strategies to mitigate them. Volume 67. European Urology: Elsevier; 2015. pp. 825–36. 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Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: The new Medical Research Council guidance. Volume 337. BMJ. British Medical Journal Publishing Group; 2008. pp. 979–83. 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 [Internet]. 2021 Sep 30 [cited 2021 Oct 5];374:n2061. Available from: https://www.bmj.com/content/374/bmj.n 2061. Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C et al. Normalisation process theory: A framework for developing, evaluating and implementing complex interventions. BMC Med [Internet]. 2010 Oct 20 [cited 2020 Jul 7];8(1):1–11. Available from: https://link.springer.com/articles/ 10.1186/1741-7015-8-63 . 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 [Internet]. 2019 Aug 1 [cited 2021 Oct 5];9(8):e029954. Available from: https://bmjopen.bmj.com/content/9/8/e029954 . Reale S, Turner RR, Sutton E, Taylor SJC, Bourke L, Morrissey D et al. Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial). BMC Health Serv Res [Internet]. 2021 Dec 22 [cited 2021 Apr 8];21(1):264. Available from: https://bmchealthservres.biomedcentral.com/articles/ 10.1186/s12913-021-06275-w . Turner RR, Arden MA, Reale S, Sutton E, Taylor SJC, Bourke L et al. The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial. BMC Health Serv Res [Internet]. 2021 Dec 25 [cited 2021 Apr 8];21(1):273. Available from: https://bmchealthservres.biomedcentral.com/articles/ 10.1186/s12913-021-06266-x . Molster C, Youngs L, Hammond E, Dawkins H. Key outcomes from stakeholder workshops at a symposium to inform the development of an Australian national plan for rare diseases. Orphanet J Rare Dis [Internet]. 2012 Aug 10 [cited 2024 Jan 12];7(1):1–10. Available from: https://ojrd.biomedcentral.com/articles/ 10.1186/1750-1172-7-50 . Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol [Internet]. 2013 Dec 18 [cited 2020 Dec 11];13(1):117. Available from: https://bmcmedresmethodol.biomedcentral.com/articles/ 10.1186/1471-2288-13-117 . Reale S, Turner RR, Sutton E, Steed L, Taylor SJC, Morrissey D et al. Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). Scientific Reports 2021 11:1 [Internet]. 2021 Jun 14 [cited 2024 Jan 12];11(1):1–12. Available from: https://www.nature.com/articles/s41598-021-91876-y . Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7(1):1–17. The Behaviour Change Wheel. : A Guide to Designing Interventions - Susan Michie, Lou Atkins, Robert West - Google Books [Internet]. [cited 2020 Apr 22]. Available from: https://books.google.co.uk/books?id=am6ytAEACAAJ &dq=The+behaviour+change+wheel&hl=en&sa=X&ved=0ahUKEwjPq6X71fvoAhVllFwKHR5SCIQQ6AEIJzAA. Alharbi TS, Carlström E, Ekman I, Olsson LE. Implementation of person-centred care: management perspective. J Hosp Adm. 2014;3(3):107. Miech EJ, Rattray NA, Flanagan ME, Damschroder L, Schmid AA, Damush TM. Inside help: An integrative review of champions in healthcare-related implementation. SAGE Open Med [Internet]. 2018 May 1 [cited 2024 Jan 12];6:1–11. https://doi.org/10.1177/2050312118773261 . Pfadenhauer LM, Gerhardus A, Mozygemba K, Lysdahl KB, Booth A, Hofmann B et al. Making sense of complexity in context and implementation: The Context and Implementation of Complex Interventions (CICI) framework. Implementation Science [Internet]. 2017 Feb 15 [cited 2024 Jan 12];12(1):1–17. Available from: https://implementationscience.biomedcentral.com/articles/ 10.1186/s13012-017-0552-5 . Holcomb J, Ferguson GM, Sun J, Walton GH, Highfield L. Stakeholder Engagement in Adoption, Implementation, and Sustainment of an Evidence-Based Intervention to Increase Mammography Adherence Among Low-Income Women. 1988 [cited 2024 Jan 12]; https://doi.org/10.1007/s13187-021-01988-2 . Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care [Internet]. 2012 Mar [cited 2021 Feb 25];50(3):217–26. Available from: https://pubmed.ncbi.nlm.nih.gov/22310560/ . May CR, Albers B, Bracher M, Finch TL, Gilbert A, Girling M et al. Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development. 2021 [cited 2024 Jan 12]; https://doi.org/10.1186/s13012-022-01191-x . Supplementary Files AdditionalFile1.docx Additional File 1 (word doc): TIDIeR Framework of the STAMINA Lifestyle Intervention This file presents a description of the STAMINA Lifestyle Intervention in accordance with the TIDIeR framework. AdditionalFile2.docx Additional File 2 (word doc): Topic Guide This file contains the topic guide that guided round table discussions at stakeholder workshop 1 and 2. The topic guide is based on the Normalisation Process Theory. AdditionalFile3.docx Additional File 3 (word doc): Stakeholder discussions mapped onto the NPT This file contains feedback from stakeholders, in stakeholder workshop 1 and 2, mapped onto the Normalisation Process Theory framework. COREQchecklist.docx Cite Share Download PDF Status: Published Journal Publication published 02 Sep, 2024 Read the published version in Implementation Science Communications → Version 1 posted Editorial decision: Major revision 08 Mar, 2024 Reviewers agreed at journal 26 Jan, 2024 Reviewers invited by journal 26 Jan, 2024 Editor assigned by journal 16 Jan, 2024 First submitted to journal 15 Jan, 2024 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board 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-3867587","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":269650575,"identity":"2ed00f19-a06a-4622-b964-9114ac60d457","order_by":0,"name":"Sophie Reale","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAw0lEQVRIiWNgGAWjYNCCAgY5BgkoWwKvSjgwYDAmXUtiA9Fa5Bt4Hz74YWCTPn92jwHDjxqGxJkNhMw/wG5s2GOQlrvhzhkDxp5jDImzCTuJjU2Cx+Bw7gaJHAMG3gaGxHmEHcbG/vOPwf90+Rk5Box/idHCcICNjZnH4EACw40cA2aQLYQddpiNWVrGINlww420gsMyxySMCXpfvr2N8eObCjt5+RnJGx++qbGRnXGAkDXMyI4kOiJHwSgYBaNgFOAHANjoNy/ipI2HAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-2421-7661","institution":"Sheffield Hallam University","correspondingAuthor":true,"prefix":"","firstName":"Sophie","middleName":"","lastName":"Reale","suffix":""},{"id":269650576,"identity":"59e75015-7a02-4d2d-ad3a-325586c60f98","order_by":1,"name":"Rebecca R Turner","email":"","orcid":"","institution":"The University of Manchester Faculty of Biology Medicine and Health","correspondingAuthor":false,"prefix":"","firstName":"Rebecca","middleName":"R","lastName":"Turner","suffix":""},{"id":269650577,"identity":"26746ac2-f9c7-47f4-a59a-8b1d7c3bf929","order_by":2,"name":"Liz Steed","email":"","orcid":"","institution":"Queen Mary University of London Wolfson Institute of Population Health","correspondingAuthor":false,"prefix":"","firstName":"Liz","middleName":"","lastName":"Steed","suffix":""},{"id":269650578,"identity":"a24c0c51-f371-42e3-b57f-d9df8448f548","order_by":3,"name":"Steph J. 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C","lastName":"Taylor","suffix":""},{"id":269650579,"identity":"d01a18b2-da5e-46e0-a0c1-4be992ef6f8e","order_by":4,"name":"Derek J Rosario","email":"","orcid":"","institution":"Sheffield Teaching Hospitals NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Derek","middleName":"J","lastName":"Rosario","suffix":""},{"id":269650580,"identity":"3d4d662f-2d2a-4f3b-af39-acdacd197d0f","order_by":5,"name":"Liam Bourke","email":"","orcid":"","institution":"Sheffield Hallam University College of Health Wellbeing and Life Sciences","correspondingAuthor":false,"prefix":"","firstName":"Liam","middleName":"","lastName":"Bourke","suffix":""},{"id":269650581,"identity":"b22f351f-79c6-4628-abcd-2631292600e1","order_by":6,"name":"Dylan Morrissey","email":"","orcid":"","institution":"William Harvey Research Institute: Queen Mary University of London William Harvey Research Institute","correspondingAuthor":false,"prefix":"","firstName":"Dylan","middleName":"","lastName":"Morrissey","suffix":""},{"id":269650582,"identity":"f0a1f653-3e0c-48b0-b3d8-c94fa1ec8683","order_by":7,"name":"Aidan Q Innes","email":"","orcid":"","institution":"Nuffield Health","correspondingAuthor":false,"prefix":"","firstName":"Aidan","middleName":"Q","lastName":"Innes","suffix":""},{"id":269650583,"identity":"0021cdeb-d597-4a95-849d-7d9ed539fbfb","order_by":8,"name":"Eileen Sutton","email":"","orcid":"","institution":"University of Bristol Population Health Sciences","correspondingAuthor":false,"prefix":"","firstName":"Eileen","middleName":"","lastName":"Sutton","suffix":""}],"badges":[],"createdAt":"2024-01-15 20:14:25","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3867587/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3867587/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s43058-024-00629-1","type":"published","date":"2024-09-02T15:57:40+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":50368830,"identity":"0c3762bb-1463-4413-b404-24964d1d9f41","added_by":"auto","created_at":"2024-01-30 12:27:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":760660,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eOverview of the STAMINA Programme Grant for Applied Research\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Reale2024Figure1NPTpaper.png","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/8fac69499c930fa0df072471.png"},{"id":50368828,"identity":"c7975b6e-56c1-42ea-8986-b940dd6a5411","added_by":"auto","created_at":"2024-01-30 12:27:27","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":304903,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eContribution of two stakeholder workshops to the development and refinement of the STAMINA complex intervention\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Reale2024Figure2NPTpaper.png","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/e01c3936cfe98d673771a902.png"},{"id":64185860,"identity":"34ef47fc-434d-4a4f-8ac7-3890f593cfe8","added_by":"auto","created_at":"2024-09-09 16:22:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1962979,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/6635ec60-f733-4b30-8d31-5648ed3f1c3c.pdf"},{"id":50368829,"identity":"1f49f730-e8d6-42f1-880b-ecd924dc2c09","added_by":"auto","created_at":"2024-01-30 12:27:27","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":19710,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional File 1 \u003c/strong\u003e(word doc): TIDIeR Framework of the STAMINA Lifestyle Intervention\u003c/p\u003e\n\u003cp\u003eThis file presents a description of the STAMINA Lifestyle Intervention in accordance with the TIDIeR framework.\u003c/p\u003e","description":"","filename":"AdditionalFile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/62386c1d7292955e27fae340.docx"},{"id":50369085,"identity":"80461701-0ead-460c-be9e-5e614c0e5434","added_by":"auto","created_at":"2024-01-30 12:35:27","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":15701,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional File 2 \u003c/strong\u003e(word doc): Topic Guide\u003c/p\u003e\n\u003cp\u003eThis file contains the topic guide that guided round table discussions at stakeholder workshop 1 and 2. The topic guide is based on the Normalisation Process Theory.\u003c/p\u003e","description":"","filename":"AdditionalFile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/58382e64030e62de7960f93f.docx"},{"id":50368832,"identity":"776f5ff0-df8d-4106-bd2a-1063a9333f6b","added_by":"auto","created_at":"2024-01-30 12:27:27","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":37457,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional File 3 \u003c/strong\u003e(word doc): Stakeholder discussions mapped onto the NPT\u003c/p\u003e\n\u003cp\u003eThis file contains feedback from stakeholders, in stakeholder workshop 1 and 2, mapped onto the Normalisation Process Theory framework.\u003c/p\u003e","description":"","filename":"AdditionalFile3.docx","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/6c7ba664cb9f5d0935867b70.docx"},{"id":50368833,"identity":"fd49651b-576a-4eef-add5-eeca3bd2b112","added_by":"auto","created_at":"2024-01-30 12:27:27","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":19602,"visible":true,"origin":"","legend":"","description":"","filename":"COREQchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-3867587/v1/d9a96a878317c36ff77eb9eb.docx"}],"financialInterests":"","formattedTitle":"Using Normalization Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: The STAMINA Lifestyle Intervention","fulltext":[{"header":"Contribution to Literature","content":"\u003cp\u003e\u003cul\u003e \u003cli\u003e \u003cp\u003eIt takes on average 17 years for 14% of original research to be integrated into clinical practice.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eWe demonstrate how implementation science and behavioural science theories and frameworks can be applied in parallel to optimise intervention development that might contribute to future implementation of complex interventions into the NHS and charity sector (i.e., Nuffield Health), in a time and resource efficient way.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThese findings address recognised gaps between research, policy, and practice by identifying acceptable and trial specific implementation strategies in aim of embedding supervised exercise into standard NHS prostate cancer care (if found to be clinically and cost effective).\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e\u003c/p\u003e\u003cp\u003eThis file presents a description of the STAMINA Lifestyle Intervention in accordance with the TIDIeR framework.\u003c/p\u003e\u003cp\u003eThis file contains the topic guide that guided round table discussions at stakeholder workshop 1 and 2. The topic guide is based on the Normalisation Process Theory.\u003c/p\u003e\u003cp\u003eThis file contains feedback from stakeholders, in stakeholder workshop 1 and 2, mapped onto the Normalisation Process Theory framework.\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003eSupervised exercise is a safe and clinically efficacious solution to address the adverse effects of androgen deprivation therapy (ADT) for prostate cancer (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Clinically meaningful improvements in fatigue and cancer specific quality of life are demonstrated following twelve weeks of supervised exercise and dietary support, with improvements being sustained up to 6-month follow-up (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). As such the National Institute for Health and Care Excellence (NICE; NG131 1.4.19) recommend that men with locally advanced and advanced prostate cancer on ADT should be offered supervised, aerobic and resistance exercise at least twice a week for 12 weeks (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). However, very few National Health Service (NHS) trusts have established adequate provision for such supervised services according to this recommendation (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). This deficit is emblematic of the barriers to translating and embedding high-quality evidence and national recommendations into complex healthcare systems.\u003c/p\u003e \u003cp\u003eAt present, it is estimated that less than half of all novel clinical innovations with proven efficacy are translated into routine healthcare (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Furthermore, it takes a considerable length of time for research findings to influence policy and practice (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Fortunately, significant recent advances in Implementation Science have yielded theories and frameworks that guide researchers towards embedding and evaluating interventions in real-world settings e.g., (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). As such, it is recommended that factors pertinent to the immediate and future implementation of interventions (i.e., within a trial and healthcare setting respectively) are explored early, during complex intervention development. Failure to consider implementation during intervention development and subsequent trial evaluation may slow or halt the uptake and translation of proven healthcare interventions into future routine care.\u003c/p\u003e \u003cp\u003eNormalisation Process Theory (NPT) (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) was developed to overcome difficulties encountered when implementing complex behavioural interventions into healthcare practice. Recent guidance on intervention development and evaluation stress the importance of encompassing strong theoretical foundations and engaging diverse stakeholders at all stages (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). NPT is a mid-range theoretical model that can be applied at different stages of research to provide an explanatory framework to help understand how practices are or may be implemented, embedded, and integrated into routine practice (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). NPT suggests the implementation of an intervention is operationalised through four main constructs: understanding the way people make sense of the work of implementing and integrating an intervention individually and as a team (\u003cb\u003econstruct 1: coherence\u003c/b\u003e); how they engage with that intervention (\u003cb\u003econstruct 2: cognitive participation\u003c/b\u003e); how they enact it in day-to-day practice (\u003cb\u003econstruct 3: collective action\u003c/b\u003e); and how they appraise its effects (\u003cb\u003econstruct 4: reflexive monitoring\u003c/b\u003e).\u003c/p\u003e \u003cp\u003eIn this paper, we used the STAMINA complex intervention as an exemplar (Additional File 1) to discuss the application of NPT during complex intervention development to identify barriers, facilitators, and consider strategies for future implementation in the NHS.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy context and approvals\u003c/p\u003e \u003cp\u003e This study contributes to a National Institute for Health and Care Research (NIHR) funded Programme Grant for Applied Research (PGfAR) aiming to evaluate the clinical and cost-effectiveness of embedding a tailored lifestyle intervention for men with prostate cancer on ADT into NHS prostate cancer care with delivery partner Nuffield Health (ISRCTN: 46385239) (See Fig.\u0026nbsp;1). The STAMINA complex intervention was developed and refined in accordance with the Medical Research Council (MRC) guidance for the development of complex interventions (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). For more information see (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). This paper provides a detailed account of two stakeholder workshops underpinned by NPT and delivered during complex intervention development. Stakeholder workshop 1 (SW1) was held in February 2019 following a review of evidence and qualitative exploration of barriers and facilitators to the target behaviours. Stakeholder workshop 2 (SW2) was held in January 2020 ahead of the complex intervention being finalised and implemented in a pragmatic randomised controlled trial (RCT) (See Fig.\u0026nbsp;2).\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 1: Overview of the STAMINA Programme Grant for Applied Research\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 2: Contribution of two stakeholder workshops to the development and refinement of the STAMINA complex intervention\u003c/b\u003e \u003c/p\u003e \u003cp\u003eRegulatory and ethical approvals were sought prior to the commencement of research activities from Sheffield Hallam University (Reference: ER10748795) and the NHS (REC reference: 18/NW/0738 / IRAS project ID: 254343). Written informed consent was collected from all participants prior to research activity.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eParticipants and Materials\u003c/h2\u003e \u003cp\u003eThe workshops brought together representatives from key stakeholder groups purposively sampled to include NHS healthcare professionals (HCPs) working in prostate cancer care, community-based exercise professionals (EPs), people with advanced prostate cancer and their families/ carers, behaviour change experts and researchers. The main aims of SW1 were to refine the intervention and address key uncertainties regarding its feasibility and acceptability when embedded into routine clinical care. SW2 was focussed on further intervention refinement - building iteratively on feedback from SW1 and qualitative intervention development work (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). SW2 also explored stakeholder opinions on the intervention materials (i.e., patient diary and information booklet), progress reporting systems and the communication pathway, with consideration to the implementation of STAMINA in day-to-day practice in both the NHS and charity sector (i.e., Nuffield Health).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProcedure\u003c/h2\u003e \u003cp\u003eWorkshop participants were allocated a group table comprised of representatives from all stakeholder groups for facilitated cross-group discussion (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) considering impacts across these groups. The format of both workshops included short explanatory presentations on various intervention elements by STAMINA research team members followed by task-based table discussions led by a facilitator (SR, RRT, ES, LS, ST, LB) and broad topic guide (Additional File 2). Each table discussion was followed by a facilitated (DM) whole group discussion as an opportunity for debate, sense checking and conclusion generation. Notes from the table and whole group discussions were written individually by table facilitators in workbooks and on flip-chart paper.\u003c/p\u003e \u003cp\u003eStakeholders were provided with feedback forms to complete at the end of the session. Moreover, written feedback was collated by table facilitators and the research team to produce a summary that was sent to all stakeholders who were then invited to send any further comments to the team via email.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eAnalysis:\u003c/h2\u003e \u003cp\u003eTo facilitate analysis of the stakeholder workshop discussions and feedback forms, we developed an analysis framework (ES) incorporating NPT constructs and sub-constructs and mapped our data onto this, paying attention to uncertainties across the different stakeholder groups and specific elements of the intervention (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). We also considered data that fell outside of the NPT constructs and thus took an inductive and deductive approach to analysis (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eNormalisation Process Theory Constructs and Sub-Constructs for the STAMINA programme\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUsing Normalisation Process Theory in developing/refining the STAMINA intervention\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCore construct\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eSub-constructs\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Coherence - \u003cem\u003eSense-making work that people do individually or collectively: understanding the purpose, value, and benefits of the STAMINA programme\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.1 Differentiation: how is STAMINA different from other interventions.\u003c/p\u003e \u003cp\u003e1.2 Communal Specification: building a shared understanding of aims, objectives, benefits of STAMINA.\u003c/p\u003e \u003cp\u003e1.3 Individual Specification: understanding specific tasks and responsibilities within STAMINA.\u003c/p\u003e \u003cp\u003e1.4 Internalization: understanding the value, benefits, importance of STAMINA.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. Cognitive Participation - \u003cem\u003eRelational work that people do to build and sustain a community of practice\u003c/em\u003e:\u003c/p\u003e \u003cp\u003e\u003cem\u003egetting buy-in, STAMINA champions.\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.1 Initiation: whether key participants are working to drive STAMINA implementation forward.\u003c/p\u003e \u003cp\u003e2.2 Enrolment: strategies used to engage (buy-in), sustain engagement, and help secure implementation.\u003c/p\u003e \u003cp\u003e2.3 Legitimation: ensuring participants believe it is right for them to be involved and they can make valid contribution.\u003c/p\u003e \u003cp\u003e2.4 Activation: collectively defining actions and procedures needed to sustain STAMINA.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. Collective Action - \u003cem\u003eOperational work that people do to enact a set of practices\u003c/em\u003e:\u003c/p\u003e \u003cp\u003e\u003cem\u003ehow STAMINA works in day-to-day practice (including roles/resources), communication pathways\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.1 Interactional Workability: interactional work people do when operationalizing STAMINA.\u003c/p\u003e \u003cp\u003e3.2 Relational Integration: knowledge work to build accountability and maintain confidence in STAMINA.\u003c/p\u003e \u003cp\u003e3.3 Skill set workability: the allocation work that underpins the division of labour built up around STAMINA.\u003c/p\u003e \u003cp\u003e3.4 Contextual integration: managing STAMINA through allocation of resources, execution of protocols, policies, procedures.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. Reflexive monitoring - \u003cem\u003eAppraisal work people do to assess and understand the ways a new set of practices affect them and the others around them: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, EPs) or taking part (patients) in STAMINA\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.1 Systemization: collecting information to determine the effectiveness/utility of STAMINA.\u003c/p\u003e \u003cp\u003e4.2 Communal appraisal: participants working together to evaluate STAMINA.\u003c/p\u003e \u003cp\u003e4.3 Individual Appraisal: participants working experientially as individuals to appraise its effects on them and the contexts in which they are set.\u003c/p\u003e \u003cp\u003e4.4 Reconfiguration: redefining procedures or modifying practices within STAMINA.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe analysis was led by a researcher with expertise in qualitative research and application of the NPT (ES). Data was cross-checked by two independent researchers (SR, RRT) and discussed where any inconsistencies were identified. Our findings were then used to inform and aid refinement of the STAMINA complex intervention ahead of examining its acceptability and feasibility when integrated into routine prostate cancer care in a feasibility study (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eINSERT Table : Normalisation Process Theory Constructs and Sub-Constructs for the STAMINA programme\u003c/h3\u003e\n"},{"header":"Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStakeholder Workshop 1\u003c/h2\u003e \u003cp\u003eTwenty-eight stakeholders attended SW1 (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Workshop participants discussed the content of the intervention and associated training packages, with a view to its potential integration into routine cancer care. We explored stakeholders\u0026rsquo; perceptions of STAMINA across the four NPT constructs and sub-constructs to help understand perceived potential benefits of STAMINA for men with prostate cancer, in addition to factors impacting upon its implementation (Additional File 3).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ea: Stakeholder workshop 1 attendees\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStakeholder\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNumber of attendees\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient and public involvement members\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNuffield Health senior staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNuffield Health Exercise Professionals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAcademic and community exercise professionals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth Economist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth psychologist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCCG\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCancer alliance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealthcare professionals (secondary care)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal Number\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eb: Stakeholder workshop 2 attendees\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStakeholder\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNumber of attendees\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient and public involvement members\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNuffield Health senior staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNuffield Health Exercise Professionals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAcademic and community exercise professionals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth psychologist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCCG\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealthcare professional (secondary care)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResearch nurse (secondary care)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealthcare professional (primary care)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMacmillan rehab lead\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePCUK\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal Number\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e28\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eINSERT Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003e: Stakeholder workshop attendees\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003ea: Stakeholder workshop 1 attendees\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003eb: Stakeholder workshop 2 attendees\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eCoherence: understanding the purpose, value, and benefits of the STAMINA programme\u003c/h2\u003e \u003cp\u003eWithin NPT the embedding of a practice (normalization) is made possible by \u0026ldquo;a set of ideas about its meaning, uses, and utility; and by socially defined and organized competencies\u0026rdquo;(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) (p542) which hold the practice together. In discussions, stakeholders recognised the importance of highlighting STAMINA\u0026rsquo;s unique selling points in professional training and patient-facing materials - including how the intervention is tailored to address individual needs (differentiation). Further key factors were ensuring that all stakeholders were made aware of the evidence base in support of the intervention (communal specification); that HCPs and EPs understood their individual roles and responsibilities within STAMINA (individual specification); and that patient-facing materials (such as STAMINA information booklets) should highlight the supportive evidence base, illustrated by patient stories, pictures and quotes. Together these factors were seen to make the practice \u0026ldquo;meaningful\u0026rdquo;, for example increasing HCP\u0026rsquo;s confidence in referring patients to the STAMINA Lifestyle Intervention (Additional file 3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCognitive participation: getting buy-in, STAMINA champions\u003c/h2\u003e \u003cp\u003eThis construct explores the \u0026ldquo;symbolic and real enrolments and engagements of human actors\u0026rdquo; (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) (p 243) that enable them to work together to build and sustain a community of practice. It was important to explore participants opinions on the possibility for the introduction of STAMINA in routine prostate cancer care \u0026ndash; would HCPs and EPs be prepared to invest time and resource into getting STAMINA up and running (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), and would men with prostate cancer on ADT be keen to participate? To facilitate HCP and EP buy-in, stakeholders highlighted the importance of enrolling STAMINA \u0026ldquo;champions\u0026rdquo; located in both the NHS and Nuffield Health to engender confidence in the intervention (enrolment) and that training would need to be flexible with advanced notice to fit in with existing roles and commitments (initiation, enrolment). It was also highlighted that demonstrating the expertise of Nuffield Health in delivering exercise programmes to clinical populations (e.g., cystic fibrosis, joint pain) and their charitable status would be key to gaining trust in the intervention (legitimation) (Additional file 3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eCollective Action: how STAMINA works in day-to-day practice (including roles/resources), communication pathways\u003c/h2\u003e \u003cp\u003eThis construct considers how actors work collectively towards specific goals as part of a particular practice (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Discussions focussed largely on early stages of implementation, for example, enabling HCPs and EPs to complete related training packages by offering different modes of deliveries (e.g., face-to-face versus remote) and hosting them on internal systems (interactional workability, contextual integration). Stakeholders also identified a need for an established referral and communication pathway, particularly in relation to assessing patient eligibility for participation and clear processes for raising concerns (relational integration; contextual integration). Furthermore, there were discussions about the current and required skillset of different roles within the fitness and wellbeing industry (e.g., physiologists, physiotherapists, and personal trainers) to identify the most suitable role and subsequent training needs to deliver the STAMINA programme \u0026ndash; with a particular focus on having the skills and confidence to tailor exercise for men with prostate cancer who often have a number of health comorbidities (skill set workability) (Additional file 3).\u003c/p\u003e \u003cp\u003e \u003cb\u003eReflexive monitoring: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, EPs) or taking part (patients) in STAMINA\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe final NPT core construct considers how actors work together to continuously evaluate the outcomes of a practice, and in turn how these impact on its potential for normalization (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Discussions briefly touched on developing clear systems for clinical escalations in emergency scenarios (systemization); as well as methods of assessing the professional training packages (communal appraisal, individual appraisal); and adapting training materials and intervention documents (i.e., progress reports) to fit with existing technological systems (reconfiguration). Factors related to this construct were discussed more extensively in SW2 (Additional file 3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eIntervention refinement following Stakeholder Workshop 1\u003c/h2\u003e \u003cp\u003eFollowing feedback from stakeholders, the STAMINA complex intervention was refined to optimise the process of embedding supervised exercise into the prostate cancer care pathway ahead of a pragmatic RCT (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Key changes included hosting high level training on Nuffield Health internal systems and mandating completion by all front of house staff, management, and sales teams to enhance awareness related to operational procedures. Moreover, the decision was made to upskill personal trainers to deliver and support patient exercise behaviour as their role within Nuffield Health more closely aligns with the requirements of delivering the STAMINA Lifestyle Intervention compared to that of a physiotherapist or physiologist. Information about Nuffield Health (e.g., charitable status, previous involvement in clinical research and exercise delivery, skillset, and mandatory training) was also added to the HCP training package and patient-facing materials alongside case study examples (quotes, patient stories, pictures etc.) to enhance understanding of the intervention purpose and subsequent buy-in.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eStakeholder Workshop 2\u003c/h2\u003e \u003cp\u003eTwenty-eight stakeholders attended SW2 (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003e). We built on the feedback from SW1 to frame discussions on the refined intervention. Discussions focussed on further refinement; progress reporting; communication pathways; and involved detailed consideration of the integration of STAMINA in day-to-day practice in both the NHS and charitable sector. There were some brief discussions related to the NPT construct of \u003cb\u003eCoherence\u003c/b\u003e, where participants re-emphasised the importance of STAMINA\u0026rsquo;s grounding in a supportive evidence-base and tailoring to fit individual patient\u0026rsquo;s needs to facilitate normalization (differentiation). Factors related to the construct of \u003cb\u003eCognitive Participation\u003c/b\u003e involved consideration of how the format of the patient facing materials might be refined to enhance acceptability of their use in the gym and prevent unwanted attention from the general public. It was also agreed that information about suitable clothing should be added so that men didn\u0026rsquo;t feel the need to invest in expensive kit (enrolment, legitimation) (Additional file 3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCollective Action: how STAMINA works in day-to-day practice (including roles/resources), communication pathways\u003c/h2\u003e \u003cp\u003eTo implement STAMINA, key stakeholders need to work together to achieve common goals. Factors related to the construct \u003cb\u003eCollective action\u003c/b\u003e were therefore discussed, including consideration of how HCPs and EPs might work together in the future to communicate key outcomes e.g., sharing patient progress with primary care staff (interactional workability). Specific roles and responsibilities in operationalizing the intervention were explored in detail, with a particular emphasis on streamlining progress reporting systems. Stakeholders also emphasised the role of the patient in taking ownership for recording their progress (skill set workability). The sub-construct of contextual integration focuses on how the introduction of a new practice affects \u0026ldquo;the mechanisms that link work to existing structures and procedures, and for realizing material and symbolic resources for them\u0026rdquo; (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) (p545). HCP and EP attendees highlighted the importance of introducing communication pathways and reporting systems that could integrate within existing systems and that they could easily incorporate within their day-to-day practice, and that these should be clearly set out in initial training packages (contextual integration). This included systems for reporting safety/health issues such as Nuffield Health\u0026rsquo;s internal Clinical Escalation policy and team (Additional file 3).\u003c/p\u003e \u003cp\u003e \u003cb\u003eReflexive monitoring: processes for measuring outcomes (team and individual) and feeding back to those delivering (HCPs, CEPs) or taking part (patients) in STAMINA\u003c/b\u003e \u003c/p\u003e \u003cp\u003eSW2 involved detailed discussion of factors related to the refinement of systems for collecting information to determine the utility/effectiveness of STAMINA (Additional File 3). There was lengthy consideration of the format, function, language/terminology, and purpose of the progress report e.g., that it should \u003cb\u003enot\u003c/b\u003e act as safety reporting tool. Similarly, stakeholders proposed and agreed that the STAMINA diary should act as a self-monitoring tool to support patient behaviour change and maintenance and should be separate to the logbooks designed for data capture/ research purposes only (systemization). Leading on from this, stakeholders discussed how patients and EPs should use the report as a tool to aid discussions to evaluate progress (communal appraisal); and that patients should be provided with the opportunity to voice opinions on their personal progress e.g., within the STAMINA diary (individual appraisal). The latter factor linked to the NPT sub-construct of legitimation, in giving men confidence to participate. Possible enhancements to the patient facing materials were also discussed e.g., adding patient stories and photographs (reconfiguration).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eIntervention refinement following Stakeholder Workshop 2\u003c/h2\u003e \u003cp\u003eFollowing SW2, the patient facing materials were refined to increase acceptability based on stakeholder recommendations. More specifically, i) the STAMINA diary was reduced from A4 to A5 and wire bound to increase usability, ii) all STAMINA logos were removed from the front and back cover and replaced with standard Nuffield Health branding to reduce the likelihood of patients \u0026lsquo;standing out\u0026rsquo; and receiving subsequent unwanted special attention and iii) additional information was added to depict appropriate clothing for exercise to enhance inclusivity. Moreover, an email communication pathway, embedded into current internal systems and IT infrastructure was established for reporting/ escalating problems and discussing patient progress between Nuffield Health and the NHS. The method was chosen for its simplicity, safety (e.g., end-to-end encryption) and future proofing (e.g., likely to work in the future regardless of changes made to internal IT systems) (Additional file 3).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis paper describes the first application of NPT to complex intervention for management of ADT side-effects in prostate cancer. Behaviour change theories (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) guided the early intervention development stages which were complemented by Implementation Science, i.e., NPT (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Stakeholder feedback was captured during round-table discussions to enhance possibilities for normalization, as they \u0026ldquo;play an important part in feeding back into notions of the coherence and meaningfulness of a practice\u0026rdquo; (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Discussions and analysis centred on NPT led to the optimisation of the STAMINA complex lifestyle intervention including patient facing materials and professional training packages. Moreover, consideration for individual roles and infrastructure within the specified contexts led to the identification of a clear and simple communication pathway to fit within the organisational structures of the NHS and the chosen delivery partner, Nuffield Health.\u003c/p\u003e \u003cp\u003eAt present, the provision of supervised exercise into the prostate cancer care pathway, as recommended by NICE, is rarely offered due to a multitude of barriers related to implementation (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). As described previously (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e), NPT was used to identify barriers and facilitators related to practicalities of NHS delivery in a sequential fashion across the two workshops. In the early phases of intervention development (i.e., SW1), the constructs of Coherence and Cognitive Participation (and related sub-constructs) were of particular relevance in our analysis. All stakeholders identified \u0026lsquo;buy-in\u0026rsquo; and a good understanding of the underpinning evidence in support of the intervention as a necessary precursor to its implementation. In particular, the introduction of STAMINA Champions, information about the charity sector and clarity on professional roles were collectively identified as mechanisms to increase HCP confidence to recommend and refer patients for exercise. Over the past decade, the use of champions has become a focal point of implementation research with systematic reviews evidencing champions as one of the core determinants of implementation success in healthcare settings (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). However, less is known about the use of champions in other contexts. In the present study, EPs agreed champions could be beneficial in the charity sector though greater emphasis was placed on which professionals should be trained to deliver the intervention and where the training was hosted as a strategy to enhance early \u0026lsquo;buy-in\u0026rsquo;. These differences highlight the importance of learning about the target contexts so that implementation strategies can be tailored accordingly (i.e., it is not a one size fits all).\u003c/p\u003e \u003cp\u003eThe NPT constructs Collective Action and Reflexive Monitoring (plus sub-constructs) were the main discussion points of SW2. Discussions were centred on how to operationalise the STAMINA Lifestyle Intervention into routine practice with consideration for future refinements ahead of delivery in the ever-changing context of the NHS and charity sector (Reconfiguration). For example, a simple and clear communication and reporting pathway between HCPs, EPs, and patients was favoured against a more complex reporting system that may require specialist software/ resource and may not be accessible to all contexts involved, now or in the future. Moreover, stakeholders agreed that intervention and research related information should be presented in separate materials to increase internal validity and so that minimal, if any, changes are required to the intervention materials ahead of national scale implementation (if found to be effective) \u0026ndash; this is advantageous from both a resource and time perspective. Failure to address context specific changes could constitute a major barrier to appraising the transferability and applicability of findings following our planned RCT and may contribute to furthering the gap between research, policy, and practice (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Instead, the workshops developed our understanding of the local contexts so that a modifiable intervention could be developed and evaluated in our process evaluation to enable future implementation in a timely fashion (if found to be effective).\u003c/p\u003e \u003cp\u003eStrengths \u0026amp; Limitations\u003c/p\u003e \u003cp\u003eConsideration of factors related to implementation as part of an iterative intervention development process was deemed essential for intervention optimisation ahead of testing in the context of a RCT. This blended approach is strengthened by its methodological rigour, time efficiency and likeliness of success compared to more traditional and sequential methods which tend to retrospectively explore implementation following intervention development and efficacy trials. Subsequently, the STAMINA Lifestyle Intervention was found to be feasible and acceptable, and delivered with moderate to high fidelity, when embedded into the NHS and Nuffield Health during a feasibility study (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMore specifically, delivering two stakeholder workshops at different phases of intervention development enabled the research team to sequentially explore the four constructs of NPT to identify theory-informed implementation strategies as the intervention evolved. Furthermore, offering two workshops enhanced stakeholder reach thus providing valuable insight into organisational specific information which has been found to increase the adoption, implementation, and sustainability of interventions (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Subsequently, attendance at the workshops may have had additional implementation benefits beyond the primary aim focussing on the intervention. For example, workshop attendance may have acted as a mechanism to enhance coherence and cognitive participation and support delivery of the trial as most clinical stakeholders submitted an expression of interest for their NHS Trust to be involved in embedding supervised exercise into the NHS as part of the STAMINA RCT.\u003c/p\u003e \u003cp\u003eApplication of the NPT during intervention development enabled us to identify and characterise key mechanisms to facilitate implementation of the STAMINA Lifestyle Intervention and aid intervention development as part of an iterative process. However, in certain instances, application of the NPT was challenging as during the analysis phase some stakeholder feedback was mapped onto multiple constructs/sub-constructs demonstrating the multifaceted interactions of different elements of a complex intervention. For example, discussions around the format and purpose of the patient diary spanned the sub-constructs of legitimation and individual appraisal. Furthermore, the researchers who have a background in behaviour change had a natural desire to code discussion items onto the Theoretical Domains Framework (TDF). This may reflect the researcher\u0026rsquo;s familiarity with the behaviour change framework and/ or highlight that the TDF is also a tool designed to assess implementation and other behavioural problems to inform intervention design (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Subsequently, we took an inductive and deductive approach to analysis and so both intervention and implementation barriers were explored in parallel to increase the usefulness and policy relevance of the research (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIf the STAMINA PGFaR is proven to be clinically and cost effective, future implementation work using NPT will be guided by the newly developed and published NPT coding manual \u0026ndash; a tool created to provide a consistent and simple set of definitions of the core constructs of the theory to support researchers with qualitative analysis (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn this paper, we discuss the first application of NPT during complex intervention development and consider possible future implementation of embedding supervised exercise into routine clinical care. This blended approach demonstrates methodological rigour, time efficiency and increased likeliness of success compared to more traditional and sequential methods which tend to retrospectively explore implementation following intervention development and efficacy trials. All four constructs of the NPT were explored to identify context specific implementation strategies to address barriers and facilitators to \u0026lsquo;normalising\u0026rsquo; processes of embedding new pathways of care into the NHS with delivery partner Nuffield Health. The NPT will provide the explanatory framework to help understand how the STAMINA complex intervention is implemented, embedded, and integrated into routine practice in a planned definitive RCT (Trial registration: ISRCTN: 46385239).\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eExercise Professional\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHCP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHealthcare Professional\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMRC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMedical Research Council\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNHS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Health Service\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNICE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Institute for Health and Care Excellence\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNIHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Institute for Health and Care Research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNPT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNormalisation Process Theory\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePGfAR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eProgramme Grant for applied research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRandomised Controlled Trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSTAMINA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSupported exercise TrAining for Men with prostate caNcer on Androgen deprivation therapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSW\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStakeholder Workshop\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTDF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTheoretical Domains Framework\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthical approval and consent to participate were sought prior to the commencement of research activities from Sheffield Hallam University (Reference: ER10748795) and the NHS (REC reference: 18/NW/0738 / IRAS project ID: 254343).\u003c/p\u003e\n\u003cp\u003eConsent for publication – not applicable\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials -\u0026nbsp;All data generated or analysed during this study are included in this published article [and its supplementary information files].\u003c/p\u003e\n\u003cp\u003eCompeting Interests – The authors declare no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFunding – This project is funded by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research (PGfAR) (Grant Reference Number RP-PG-1016-20007). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.\u003c/p\u003e\n\u003cp\u003eAuthor contributions: Conceptualization: LS, SJC; Methodology: SR, RT, ES, DM; Formal Analysis: ES, SR, RT; Writing-Original Draft Preparation: SR, ES; Writing-Review \u0026amp; Editing: SR, ES, RRT, SJC, LS, DR, LB, DM, AI; Funding Acquisition: DJR and LB. All authors read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAcknowledgements - To participants, the PPI group, Nuffield Health, and STAMINA co-applicants. The STAMINA co-applicants include Tom Baker, Professor Janet Brown, Michelle Collinson, Professor Patrick Doherty, Professor Amanda Farrin, Professor Diana Greenfield*, Suzanne Hartley, Professor Jenny Hewison, Professor Malcom Mason, and Dr David Meads.\u003c/p\u003e\n\u003cp\u003eAdditional author information: * Diana Greenfield is a National Institute for Health Research (NIHR) Senior Nurse Research Leader. The views expressed in this article are those of the author and not necessarily those of the NIHR, or the Department of Health and Social Care.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, et al. Exercise for men with prostate cancer: A systematic review and meta-analysis. European Urology. Volume 69. 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Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development. 2021 [cited 2024 Jan 12]; \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13012-022-01191-x\u003c/span\u003e\u003cspan address=\"10.1186/s13012-022-01191-x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Intervention Development, Normalisation Process Theory, Behaviour Change, Prostate Cancer, Exercise, Lifestyle, Stakeholders, Complex intervention, Process Evaluation, Implementation","lastPublishedDoi":"10.21203/rs.3.rs-3867587/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3867587/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how implementation of NICE recommendations within a trial context was explored during complex intervention development to enable evaluation of a lifestyle intervention.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eTwo stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored strategies for embedding SLI into the context of the NHS with delivery partner Nuffield Health.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eWorkshops were attended by healthcare professionals (n\u0026thinsp;=\u0026thinsp;16), exercise professionals (n\u0026thinsp;=\u0026thinsp;17), members of public involved in PPI (n\u0026thinsp;=\u0026thinsp;12), health psychologists (n\u0026thinsp;=\u0026thinsp;2), clinical commissioners (n\u0026thinsp;=\u0026thinsp;4), cancer charities (n\u0026thinsp;=\u0026thinsp;3), a cancer alliance (n\u0026thinsp;=\u0026thinsp;1) and health economist (n\u0026thinsp;=\u0026thinsp;1). Stakeholders agreed that professional training packages should emphasise the uniqueness of SLI and underpinning theory and evidence (\u003cem\u003eCoherence\u003c/em\u003e). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (\u003cem\u003eCognitive participation\u003c/em\u003e). Furthermore, a simple communication (\u003cem\u003eCollective Action\u003c/em\u003e) and progress reporting system (\u003cem\u003eReflexive Monitoring\u003c/em\u003e) was suggested to fit into existing infrastructure within the NHS and community partner.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eApplication of NPT within two stakeholder workshops optimised complex intervention development. Context-specific strategies to support implementation of the STAMINA Lifestyle Intervention within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003e(ISRCTN: 46385239).\u003c/p\u003e","manuscriptTitle":"Using Normalization Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: The STAMINA Lifestyle Intervention","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-30 12:27:22","doi":"10.21203/rs.3.rs-3867587/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2024-03-08T15:51:56+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-01-26T22:05:58+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-01-26T22:01:05+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-01-17T02:37:51+00:00","index":"","fulltext":""},{"type":"submitted","content":"Implementation Science Communications","date":"2024-01-16T03:24:51+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f2102e20-8586-419d-a803-f5b62d3d5cee","owner":[],"postedDate":"January 30th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-09-09T16:14:09+00:00","versionOfRecord":{"articleIdentity":"rs-3867587","link":"https://doi.org/10.1186/s43058-024-00629-1","journal":{"identity":"implementation-science-communications","isVorOnly":false,"title":"Implementation Science Communications"},"publishedOn":"2024-09-02 15:57:40","publishedOnDateReadable":"September 2nd, 2024"},"versionCreatedAt":"2024-01-30 12:27:22","video":"","vorDoi":"10.1186/s43058-024-00629-1","vorDoiUrl":"https://doi.org/10.1186/s43058-024-00629-1","workflowStages":[]},"version":"v1","identity":"rs-3867587","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3867587","identity":"rs-3867587","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}