Effect of a Digital Peer Navigation Intervention among Patients after Treatment for Prostate Cancer: A Randomized Controlled Trial

Effect of a Digital Peer Navigation Intervention among Patients after Treatment for Prostate Cancer: A Randomized Controlled Trial | 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 Article Effect of a Digital Peer Navigation Intervention among Patients after Treatment for Prostate Cancer: A Randomized Controlled Trial Jacqueline L. Bender, Arminée Kazanjian, Robin Urquhart, Andrew Matthew, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8734539/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 11 You are reading this latest preprint version Abstract Purpose: Patients with prostate cancer (PC) often lack personalized support and self-management skills and face barriers to care when dealing with treatment-related side effects. We examined the effect of digital peer navigation on patient-reported outcomes after treatment for PC. Patients and Methods: In this phase III trial, conducted in 3 cancer centers in Toronto, Halifax and Vancouver, Canada, patients with localized PC who completed treatment <3 months prior were randomly assigned 1:1 to digital peer navigation or an online resource library (ORL-control). The primary outcome was patient activation (PAM-13; ability to manage one’s health and healthcare) at 3 months. Secondary exploratory outcomes were PAM-13 at 6 months, and quality of life (EQ5D-5L, PORPUS), anxiety (GAD-7), depression (PHQ-9), social support (ESSI), fear of recurrence (FCR-SF), supportive care needs (SCNS-SF34), healthcare use at 3 and 6 months. Results: From May/13/2022 to June/26/2024, 172 eligible patients (mean age 67 ±7.6 years) were randomized. At 3 months, PAM-13 was higher in the intervention compared to ORL-control (adjusted mean difference (AMD)=4.41 [95% CI: 0.96, 7.86]; p=0.012). There were improvements in EQ5D-5L (mean difference (MD)=0.05 [0.006, 0.09]; p=0.021), PHQ-9 (MD=-1.53 [ -3.05, -0.015]; p=0.048), SCNS-SF34 (MD=-7.30 [-14.07, -0.533]; p=0.035) and non-oncology medical specialist use (23.44% vs 45.7%; p=0.007) at 3 months, and SCNS-SF34 (MD=-6.44 [-12.66, -0.22]; p=0.043) at 6 months. Study groups did not differ on PAM-13, EQ5D-5L, or PHQ-9 at 6 months, or the remaining outcomes at 3 or 6 months. Conclusion: Digital peer navigation improved patient activation after PC treatment and may also improve QoL and reduce depression, supportive care needs, and non-oncology medical specialist use. Future work should explore how to implement and sustain the effects of digital peer navigation. Biological sciences/Cancer Health sciences/Health care Health sciences/Oncology Health sciences/Urology Figures Figure 1 Figure 2 INTRODUCTION Prostate cancer is highly prevalent worldwide 1 and affects 1 in 8 Canadian males 2 . Although localized prostate cancer has a 5-year disease-free survival rate above 90% 2 , local treatments often result in persistent side effects that diminish quality of life (QOL) 3 , including erectile dysfunction, urinary incontinence, and bowel problems 3 – 5 . Hormonal therapy can cause body feminization, hot flashes, fatigue, loss of libido, osteoporosis, and increased risk of diabetes and cardiovascular disease 6 – 8 . Many patients report insufficient information, emotional support, and self-management skills 9 ,10 11 , as well as barriers to care 9 , 12 , 13 contributing to unmet supportive care needs 10 , 14 , 15 . A Canadian population-based study found that prostate cancer survivors reported the highest unmet needs of all cancer survivor groups 16 . Patient navigation is a personalized intervention delivered by clinical, lay, or peer (cancer survivor) navigators that aims to address barriers to care, facilitate timely access to healthcare services, and reduce disparities in outcomes 17 . An overview of 61 systematic reviews and 53 primary studies of cancer patient navigation found strong evidence for improved screening rates, timeliness of diagnostic resolution and treatment initiation; emerging evidence for improved patient satisfaction and QOL post-treatment; inconsistent evidence for reduced distress; and potential cost-effectiveness for screening 18 . Patient navigation may be particularly valuable for men with prostate cancer, given men’s general reluctance to seek help 19 and the emasculating effects of prostate cancer treatment 19 . However, most patient navigation studies have focused on female patients and female navigators 20 . Only five RCTs have examined patient navigation in prostate cancer: four used lay navigators, two incorporated peer navigators 21 – 25 and none focused on the post-treatment period. In addition, no RCTs have evaluated technology-based navigation, despite calls from government agencies in the United States 26 , Canada 27 , and Australia 28 to leverage technology in patient navigation to improve equity in cancer care. In this study, we evaluated the effect of digital peer navigation on patient-reported outcomes after treatment for prostate cancer. Patients with prostate cancer value support from peers to deal with treatment-related side effects and empower them to be proactive in managing their health 29 . Peer support can improve cancer patients’ knowledge and self-management self-efficacy, while reducing distress 10 , 30 , 31 . Engaging peer navigators is less costly than employing clinical navigators and offers survivors an opportunity to use their expertise and enhance their psychosocial wellbeing 32 . Based a pilot study 33 , we hypothesized that patients who received digital peer navigation would report higher patient activation (knowledge, skills, and confidence to manage one’s health and healthcare) 34 , better QOL, and less supportive care needs. PATIENTS AND METHODS Trial Design We conducted a multi-center, type-1, hybrid effectiveness-implementation study 35 . Here we report on the efficacy of the intervention, evaluated using a phase III pragmatic RCT 36 with an active wait-list control, individual patient randomization, blinded outcome assessment, and embedded process evaluation. We used the PRECIS-2 tool 37 to design the RCT, adopting broad inclusion criteria and recruiting across several clinics. The protocol was approved by institutional ethics boards (UHN #21-5126, UBC #H21-01755 and NSH #1027115) and registered on clinicaltrials.gov (NCT05041504; Sept/13/2021). Reporting followed the CONSORT Extension for Pragmatic Trials 38 . Participants, Settings and Procedures Participants were patients diagnosed with localized prostate cancer, who had completed primary treatment < 3 months prior, had an active email address or could obtain one, and could read and speak English. Patients were excluded if they were on active surveillance, had metastatic cancer, or were not willing to be randomized. From May/13/2022 to June/26/2024, patients were recruited during regular appointments in the urology and radiation oncology clinics at the Princess Margaret Cancer Centre, University Health Network (UHN; Toronto); the urology and radiation oncology clinics at the Queen Elizabeth II Health Sciences Centre (QEII; Halifax); and the radiation oncology clinic at British Columbia Cancer (BC Cancer; Vancouver). Study information was shared with clinicians and clinic administrators, study posters and postcards were placed in common areas, and clinicians shared postcards with patients. Interested patients were contacted by research staff in-person or by phone. Randomization was centralized, web-based, generated by REDCAP, and managed by the Department of Biostatistics at UHN. After providing informed consent and completing a baseline questionnaire, eligible patients were randomly allocated in a 1:1 ratio to the intervention or control group and stratified by site using variable block sizes of 2 and 4. Assessments were administered through REDCAP at baseline, 3 and 6 months, with three weekly follow-up reminders, if needed. Study Arms Digital Peer Navigation (intervention) Patients in the intervention group received 3 months of digital peer navigation through the PeerNav app ( https://peernavigation.truenth.ca/ ) available as an Apple or Google Play mobile app and via web browsers. After singing-in and answering questions about their diagnosis, sociodemographic profile, and support needs, they viewed the profiles of available peer navigators who matched their criteria and selected a peer navigator. Navigators were trained to 1) assist in identifying needs and overcoming barriers to care; 2) provide practical, informational and emotional support; and 3) encourage a proactive approach to managing health and accessing healthcare. To accomplish these core functions, navigators reviewed patients’ self-reported needs assessment, established a regular communication schedule (weekly for the first month then bi-weekly), communicated via in-app messaging, video calls, or telephone; and shared resources from the in-app online resource library (ORL). The ORL was a searchable catalogue of curated resources about prostate cancer. For all interactions, navigators used communication guides and documented needs within the app. Peer navigators were diagnosed with prostate cancer and at least one-year post-treatment. They were recruited through referrals from clinicians and community partners including the Walnut Foundation (Black men’s health organization), Prostate Cancer Support Toronto, and Prostate Cancer Support Vancouver and Burnaby, and Blacks in Nova Scotia. They ranged in age, diagnosis (localized/locally advanced), treatments, and race/ethnicity. All completed a proven 8-week, competency-based, online training course 39 , then received supervision from a clinical psychologist through monthly virtual group debriefing sessions. The project team managed real-time supervision and case management. Online Resource Library (ORL-control) Patients in the control group accessed the same ORL via a unique study website. This methodological strong active control condition 36 , accounted for the ORL and digital delivery’s effects and reflected usual conditions, given that most prostate cancer patients seek information online 40 . Trial End Point The primary outcome was patient activation at 3 months, assessed with the Patient Activation Measure (PAM-13) 37 . This measure evaluates patients’ knowledge, beliefs, and confidence in managing their health and healthcare 34 . It is a recommended patient-reported outcome for patient navigation 41 , reflects the navigation expectations of patients with prostate cancer (e.g. to be empowered to conduct health-related conversations, ask questions, and proactively cope with treatment side effects) 29 , and is associated with a broad range of health outcomes 42 . The PAM-13 consists of 13 items scored on a 4-point Likert scale, summed, and transformed to 0-100 metric, where higher scores indicate greater activation. A four-point difference in PAM-13 is considered a minimal clinically important difference (MCID) 43 . Outcome Measures Secondary exploratory outcomes included QOL, psychosocial wellbeing, supportive care needs, healthcare service use, acceptability, and fidelity. To examine whether effects were maintained, we examined PAM-13 scores at 6 months, which was 3 months after peer navigation concluded. Health-related QOL was measured using the 5-item EQ-5D-5L 44 (transformed score range, 0–1; 1 represents perfect health; MCID, 0.01–0.06) 45 . Prostate cancer-specific QOL was measured using the 10-item Patient-Oriented Prostate Utility Scale (PORPUS) 46 (transformed score range, 0-100; higher scores indicate better QOL). Anxiety was measured using the 7-item Generalized Anxiety Disorder (GAD-7) 47 (score range 0–21, higher scores indicate worse anxiety). Depression was measured using the 9-item Patient Health Questionnaire (PHQ-9) 48 (score range, 0–27; higher scores indicate worse depression). Fear of cancer recurrence was measured with the 9-item Fear of Cancer Recurrence Inventory Short Form (FCR-SF) 49 (score range, 0–36; higher scores indicate worse FCR). Social Support was measured using the 7-item Enriched Social Support Scale (ESSI) 50 (score range, 8–34; higher scores indicate better social support). Supportive care needs were measured using the 34-item Supportive Care Needs Survey Short Form (SCNS-SF34) 51 (transformed score range, 0-100; higher scores indicate higher needs). Resource use was measured using the Health and Social Services Utilization Inventory (HSSUI) 52 . A priori hypothesized covariates associated with PAM-13 at 3-months included age, education, income, race/ethnicity, province, treatment, and navigator satisfaction. Acceptability was assessed by measuring program and navigator satisfaction. Program satisfaction was measured with a 13-item customized program satisfaction measure. Navigator satisfaction was measured with the 9-item Satisfaction with Interpersonal Relationship with Navigator Scale (score range, 9–45; higher scores indicate higher satisfaction) 53 . Fidelity was assessed by measuring: i) number and medium of patient-navigator interactions extracted from the app and navigator logs; ii) nature of patient-navigator interactions, including needs discussed extracted from the app; and iii) number and type of resources accessed from ORL in the intervention compared to the control group extracted from the app. Statistical Analysis The sample size was calculated to detect a six-point between-group difference in the PAM-13 scores at 3 months based on an analysis of covariance (ANCOVA), adjusting for baseline. To achieve 80% power at a 5% significance level, assuming a within-subject correlation of 0.72 and a common standard deviation of 20 based on the pilot study 33 , a total of 100 participants (50 per group) was required. To account for 35% loss to follow-up based on the pilot study, we aimed to recruit 152 patients. The primary analysis compared PAM-13 scores at 3 months between the intervention and control groups using ANCOVA, adjusted for baseline. As a sensitivity analysis, multiple imputation was employed to address missing data. The primary intention-to-treat analysis was conducted in accordance with our statistical analysis plan. The PAM-13 scores at 6 months, were analyzed using the similar ANCOVA model adjusted for baseline. Other secondary analyses were conducted without adjustment for multiplicity, as these were exploratory in nature. Continuous outcomes were compared between groups at each time point using t-tests. Subscale scores with highly skewed distributions were compared at each time point using linear quantile regression at the median. Regression models were used to explore factors associated with the PAM-13 scores at 3 months in the intervention group. We also conducted post hoc exploratory analyses to examine whether the number and duration of patient-navigator interactions were associated with the PAM-13 scores at 3 months in the intervention group. Data management and all statistical analysis were performed using SAS 9.4 (SAS institute Inc., Cary, NC). A two-sided p-value of < 0.05 was considered significant. RESULTS Participant Characteristics Of 664 potentially eligible patients approached, 172 patients were randomized: 86 to the intervention group and 86 to the control group (Fig. 1 ). Baseline characteristics were balanced between the two groups (Table 1 ). Table 1 Participant Characteristics Variable All (N = 172) Control (N = 86) Intervention (N = 86) Age, years Mean (SD) 67.1 (7.6) 67.3 (7.3) 66.9 (7.9) Race/Ethnicity, n (%) Asian (East/South) 11 (6.5) 5 (5.9) 6 (7.1) Black (African/Caribbean) 10 (5.9) 4 (4.7) 6 (7.1) White (European/North American) 138 (81.7) 69 (81.2) 69 (82.1) Other 10 (5.9) 7 (8.2) 3 (3.6) Place of birth, n (%) Canada 112 (65.1) 57 (66.3) 55 (63.9) Other 60 (34.9) 29 (33.7) 31 (36.1) Province, n (%) BC 38 (22.1) 20 (23.3) 18 (20.1) NS 10 (5.8) 6 (7.0) 4 (4.6) ON 124 (72.1) 60 (69.8) 64 (74.4) Education, n (%) Primary/Secondary 18 (10.7) 8 (9.4) 10 (12.1) College/University 150 (89.3) 77 (90.6) 73 (87.9) Household Income $ 100,000 80 (53.0) 37 (49.3) 43 (56.6) Relationship status Married 143 (83.1) 67 (77.9) 76 (88.4) Single 29 (16.9) 19 (22.1) 10 (11.6) Cancer Diagnosis Localized 160 (93.0) 80 (93.0) 80 (93.0) Locally advanced 6 (3.5) 2 (2.3) 4 (4.6) Don’t know 5 (2.9) 3 (3.5) 0 (0.0) Prefer not to answer 1 (0.6) 1 (1.2) 2 (2.3) Treatment Surgery 107 (62.1) 50 (58.1) 57 (66.3) Radiation 63 (36.6) 35 (40.7) 28 (32.6) ADT 43 (25.4) 23 (27.1) 20 (23.8) Outcome Measures at baseline (Score Range) PAM-13 (0-100) Mean (SD) 77.78 (13.49) 76.37 (13.01) 79.19 (13.88) Activation 1 1 (0.58%) 0 (0.00%) 1 (1.16%) Activation 2 4 (2.33%) 1 (1.16%) 3 (3.49%) Activation 3 46 (26.74%) 31 (36.05%) 15 (17.44%) Activation 4 121 (70.35%) 54 (62.79%) 67 (77.91%) EQ-5D-5L (0–1) Mean (SD) 0.85 (0.11) 0.84 (0.10) 0.85 (0.11) PORPUS (0-100) Mean (SD) 62.37 (13.37) 61.51 (13.47) 63.23 (13.30) GAD-7 (0–21) Mean (SD) 11.22 (4.43) 11.47 (4.74) 10.97 (4.11) PHQ-9 (0–27) Mean (SD) 13.23 (4.51) 13.47 (5.12) 12.99 (3.81) ESSI (6–31) Mean (SD) 25.72 (5.80) 25.02 (6.30) 26.41 (5.19) FCRI-SF (0–27) Mean (SD) 21.67 (6.37) 21.50 (6.63) 21.84 (6.15) SCNS-SF34 (0-100) Mean (SD) 26.79 (20.35) 29.49 (21.85) 24.08 (18.47) Note. No missingness was observed in baseline characteristics and baseline outcome measures Primary Outcome At 3 months, the adjusted mean PAM-13 score was higher in the intervention group compared to the control group (adjusted mean difference [AMD] = 4.41 [95% CI: 0.96, 7.86]; p = 0.012). Sensitivity analyses using multiple imputation yielded consistent results (Table 2 ). Table 2 PAM‑13 scores at 3 and 6 months Primary Outcome Control Mean (SD) [n] Intervention Mean (SD) [n] Adjusted Mean Difference (95% CI) P Value PAM-13 at 3 months 76.49 (12.96) [71] 84.34 (14.79) [65] 4.41 (0.96, 7.86) 0.012 PAM-13 at 3 months (based on MI) 77.56 (14.38) [86] 85.14 (15.89) [86] 5.63 (1.20, 10.06) 0.013 PAM-13 at 6 months 77.15 (14.61) [68] 80.25 (16.64) [59] -0.079 (-4.22, 4.07) 0.97 Note. N=available data, the missingness = 86-n; Adjusted Mean Difference (AMD) was estimated based on an ANCOVA model for the outcome adjusted for baseline PAM-13. MI: sensitivity analysis for the primary outcome based on multiple imputation (MI) method. Secondary Outcomes PAM-13 and Associated Factors At 6 months, the adjusted mean PAM-13 scores in the intervention and control groups were not significantly different (AMD = 0.08 [95% CI: -4.22, 4.06]; p = 0.97). Participants who were partnered had higher PAM-13 scores at 3 months compared to those who were single (MD = 12.24 [95% CI: 1.12, 23.36]; p = 0.031). No other associations were observed ( Appendix I, Fig. 2 ). Quality of Life At 3-months, the mean EQ-5D-5L score was higher in the intervention group compared to the control group (MD = 0.05 [95% CI: 0.006, 0.09]; p = 0.021) (Table 3 ). Subscale analysis showed fewer patients with anxiety/depression in the intervention group at 3 months and 6 months ( Appendix II). No significant between-group differences were observed in mean PORPUS scores at 3 or 6 months (Table 3 ). Table 3 Secondary exploratory outcomes at 3 and 6 months Outcomes Time (months) Control Mean (SD) [n] Intervention Mean (SD) [n] Mean Difference (intervention vs control) (95%CI) P Value EQ-5D 3 0.85 (0.14) [69] 0.90 (0.082) [64] 0.05 (0.006, 0.09) 0.021 6 0.86 (0.13) [66] 0.88 (0.13) [59] 0.02 (-0.025, 0.067) 0.38 PORPUS 3 69.17 (14.91) [71] 72.57 (11.43) [65] 3.41 (-1.24, 8.04) 0.14 6 69.55 (14.28) [67] 72.65 (13.40) [59] 3.10 (-1.78, 8.01) 0.21 GAD7 3 10.91 (4.94) [70] 9.54 (4.02) [65] -1.38 (-2.92, 0.16) 0.08 6 10.44 (4.71) [66] 9.41 (3.91) [59] -1.03 (-2.56, 0.51) 0.19 PHQ-9 3 12.90 (4.33) [70] 11.37 (4.57) [65] -1.53 (-3.05, -0.015) 0.048 6 12.73 (5.04) [67] 11.75 (4.11) [59] -0.99 (-2.62, 0.65) 0.24 ESSI 3 20.85 (10.88) [86] 20.54 (12.21) [86] -0.31 (-3.79, 3.17) 0.86 6 19.19 (11.39) [86] 18.44 (12.79) [86] -0.74 (-4.39, 2.90) 0.69 FCRI-SF 3 17.46 (5.36) [70] 16.63 (5.32) [65] -0.83 (-2.65, 0.99) 0.37 6 21.02 (6.70) [67] 20.15 (6.08) [59] -0.86 (-3.13, 1.41) 0.45 SCNS-SF34 3 22.51 (21.71) [70] 15.21 (17.68) [65] -7.30 (-14.07, -0.533) 0.035 6 20.06 (19.27) [67] 13.62 (15.51) [59] -6.44 (-12.66, -0.22) 0.043 Note. n=available data, the missingness = 86-n; The reported p-values were based on comparisons between the two groups using Student t test. Psychosocial Wellbeing At 3 months, the mean PHQ-9 score was lower in the intervention group compared to the control group (MD=-1.53 [95% CI: -3.05, -0.015]; p = 0.048) (Table 3 ). No significant between-group differences were observed in mean GAD-7, FCRI-SF, or ESSI scores at 3 months or 6 months, or PHQ-9 score at 6 months. Supportive Care Needs SCNS-SF34 mean scores were lower in the intervention compared to the control group at 3 months (MD=-7.30 [95% CI: -14.07, -0.533]; p = 0.035) and at 6 months (MD=-6.44 [95% CI: -12.66, -0.22]; p = 0.043) (Table 3 ). Subscale analysis showed reductions in psychological needs at 6 months and patient care/support needs at 3 and 6 months in the intervention group compared to the control group ( Appendix III). Healthcare Service Use At 3 months, fewer patients in the intervention group had seen other medical specialists outside of routine oncology follow-up visits (e.g. urologist, respirologist, radiotherapist, psychiatrist), compared to the control group (23.44% vs 45.7%, p = 0.007). No significant between-group differences were observed in healthcare service use at 6 months. Acceptability Median program satisfaction was 9 (IQR = 2) (mean 8.8 ± 1.7), and median navigator satisfaction was 45 (IQR = 4) (mean 41.9 ± 5.2). Fidelity Patients in the intervention group had mean 5.5 ± 3.4 interactions with their navigator; and 33 (54%) had more than 6 interactions (Table 4 ). Interaction duration was mean 34.5 minutes ± 17.3, and those who had more than 6 interactions had longer interactions (mean 40 minutes ± 19.1). Neither number nor duration of interactions were associated with PAM-13 scores. A total of 458 messages were exchanged on the app. According to navigator reports (n = 372), most interactions occurred via in-app messaging (n = 148, 38%) or telephone (n = 153, 39%), and most needs (n = 592) focused on treatment side effects (n = 236, 40%). Patients in the control group accessed more resources from the ORL (n = 232) than patients in the intervention group (n = 137); however, the difference was not significant (3.63 ± 6 vs 2.58 ± 3, p = 0.25). Table 4 Fidelity and App Usage Data Item Summary statistic Frequency of Interactions Number of interactions with navigators, mean (SD) 5.5 (3.4) ≥ 6 interactions, count (%) 28 (46%) < 6 interactions, count (%) 33 (54%) Duration of Interactions Interaction duration (mins), mean (SD) 35 (24) Interaction duration (mins) when ≥ 6 interactions, mean (SD) 40 (19.1) Interaction duration (mins) when < 6 interactions, mean (SD) 30 (14.4) Medium of Interactions (n = 372 interactions logged) Telephone, count (%) 153 (41%) In-app messaging, count (%) 148 (40%) Email, count (%) 57 (15%) Video, count (%) 8 (2%) In-person, count (%) 6 (2%) In-app messaging communication Total messages received by navigators, count 255 Messages received by navigator, mean (SD) 4.8 (7) Total messages sent by navigators, count 203 Messages sent by navigator, mean (SD) 3.5 (6.5) Needs Discussed (n = 592 needs logged) Side-effects, count (%) 236 (40%) Information, count (%) 162 (27%) State of mind, count (%) 116 (20%) Relationships, count (%) 52 (9%) Spirituality, count (%) 19 (3%) Practical concerns, count (%) 7 (1%) Health Resource Library Use Intervention patients Resources accessed, mean (SD) 2.58 (3) Total resources accessed, count 137 Unique resources accessed, count 53 Control patients Resources accessed, mean (SD) 3.63 (6) Total resources accessed, count 232 Unique resources accessed, count 64 DISCUSSION In this phase III trial, a digital peer navigation intervention improved patient activation and suggested improvements in QOL and reduced depression, and non-oncology specialist use among patients after treatment for prostate cancer, as well as sustained reduction in supportive care needs. These findings contribute to growing evidence on the benefits of patient navigation for cancer patients in the post-treatment survivorship phase of the cancer care continuum. Clinically significant improvements were observed in patient activation and QOL. Patients in the intervention group who were in a relationship reported higher PAM-13 scores, an association that has not been reported previously 54 . Partner support may reinforce the effect of a patient activation intervention in men. Higher EQ-5D-5L scores were likely largely due to reduced anxiety/depression subscale scores, which may explain the lack of difference in PORPUS which focuses on physical symptoms. Improvements in physical functioning may require longer peer navigation to master and sustain self-care strategies 55 and access clinically supervised rehabilitation 56 . Improvements were also observed in depression, measured by the PHQ-9, but not in anxiety, measured by the GAD-7. The Memorial Anxiety Scale, which assesses prostate cancer-specific anxiety, may be a more sensitive measure in this population 57 . Correspondingly, improvements in supportive care needs were likely largely due to reduced needs in the psychological subscale and the patient care/support subscale. The intervention may have had a greater impact on patients’ psychosocial needs. Support from a peer navigator to address psychosocial needs, may have reduced patients’ need for non-oncology medical specialty services, potentially resulting in cost-savings. The physical effects of prostate cancer and its treatment can be highly distressing 4 ,5859, 60 leading to changes in physical, sexual, and social functioning 61 , 62 . Yet, many men are reluctant to seek professional help for these stigmatizing issues 19 and would prefer support from another man who has experienced similar treatment-related side effects 10 . Matching patients with trained cancer survivors who have had similar experiences normalizes the experience, provides coping strategies and resource referrals, which can enhance self-efficacy while reducing distress. An RCT of an in-person, one-on-one peer support program for men after a radical prostatectomy similarly observed improvements in self-efficacy and reduced depression 63 . Fidelity assessment confirmed that the intervention was delivered as intended supporting the internal validity of the findings 64 . Patients communicated on average 5.5 times with their navigator (34.5 minutes each) over 3 months and were highly satisfied. Most interactions focused on coping with treatment-related side effects. Neither number nor duration of patient-navigator interactions were associated with PAM-13 scores, indicating that the dose was likely appropriate. Notably, patients in the control group accessed more resources from the ORL, but the difference was not significant. Hence, information alone may not be sufficient to improve these outcomes. These findings have important implications for self-directed navigation interventions, which may be the least-resource intensive form of navigation in a stepped care pathway 65 . Not all intervention effects were sustained after peer navigation was discontinued. Some degree of skill fade-out or diminishing impacts is the norm for interventions targeting psychological outcomes like skills, capacities, and beliefs 66 . It is also possible that the duration of navigation was insufficient for some people. In Chan’s umbrella review of cancer patient navigation, intervention duration ranged from 1 week to 7 years 18 . In practice, if a patient still felt they needed navigation, it would not be advisable to discontinue the service. For most patients, the need for navigation would decline over time, but some may require re-entry to navigation services as new needs arise, and others would probably benefit from longer-term service to sustain the benefits. Future research should examine a longer duration of navigation and re-entry to navigation services as needed. Limitations This study has limitations. Although the overall sample was representative of the Canadian population with respect to the proportion of Black-identifying participants 67 , most patients were white North American/European, and few self-identified with other racial/ethnic backgrounds. Most patients were also college/university educated with high household incomes and high baseline patient activation. While long-standing partnerships with trusted community agencies guided recruitment, more tailored and targeted recruitment strategies are needed to reach a diverse sample 68 . This study was restricted to patients with localized disease; future work should investigate the effect of digital peer navigation among patients with metastatic disease. Some patients withdrew from the intervention due to discomfort with technology. Strategies to engage patients with less technology proficiency may include providing technology support and manually matching patients with navigators by phone. The loss-to-follow-up at 6 months may have reduced the precision of the outcome estimates and potentially introduced bias. The positive results at 3 months for our primary outcome and several secondary outcomes are nonetheless encouraging. CONCLUSION In conclusion, digital peer navigation improved patient activation and may improve overall QOL, and reduce depression, supportive care needs and non-oncology medical specialist use in patients after treatment for prostate cancer. Future work should explore how to implement and sustain the effects of digital peer navigation in routine care. Declarations Ethics Approval: The protocol was approved by institutional ethics boards (UHN #21-5126, UBC #H21-01755 and NSH #1027115) in accordance with the Declaration of Helsinki. Author Contributions: JLB conceived the project with contributions from all authors; JLB, AK, RU, AM, LM, AV, XYY, ZAL, NP, PWMC, RR, MM, DB, RF, RHH, LJ, AF, JJ contributed to the design of the work; JLB, AK, RU, LM, AV, NP, PWMC, RR, MM, DB, RF, LJ, AF, JJ contributed to the acquisition of the data; JLB, AK, RU, XYY, ZAL, AM, LM, AV, CZ, JJ contributed to the analysis and interpretation of the data; JLB drafted the manuscript and XXY and ZAL prepared the tables; All authors reviewed and edited the draft version of the manuscript; and approved the final version. Acknowledgments: This study was funded by the Canadian Institutes of Health Research [#438539]. The funder played no role in study design, data collection, analysis and interpretation of data, or the writing of this manuscript. We would like to acknowledge and thank the Peer Navigators for their participation in and support of the project, and the patients for their time. Competing Interests: All authors declare no financial or non-financial competing interests. Data Availability: Data are available upon request from the corresponding author. Presentations: This work has been presented in part at the following conferences: Canadian Association of Psychosocial Oncology (Toronto, 2025) and the Multinational Association for Supportive Care in Cancer (Seattle, 2025). References Wang L, Lu B, He M, Wang Y, Wang Z, Du L. Prostate Cancer Incidence and Mortality: Global Status and Temporal Trends in 89 Countries From 2000 to 2019. Front Public Health . 2022;10:811044. doi:10.3389/FPUBH.2022.811044 Canadian Cancer Society. Canadian Cancer Statistics 2025 | Canadian Cancer Society. 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Jones","email":"","orcid":"","institution":"University Health Network","correspondingAuthor":false,"prefix":"","firstName":"Jennifer","middleName":"M.","lastName":"Jones","suffix":""}],"badges":[],"createdAt":"2026-01-29 18:39:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8734539/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8734539/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102621541,"identity":"527def7b-b026-40fd-a91b-933c8f8a9107","added_by":"auto","created_at":"2026-02-13 16:51:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":224205,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCONSORT Diagram\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNote. Patient Withdrawal: 1patient withdrew before random assignment because he no longer required support; 2 patients withdrew before 3-month assessment, 1 because he no longer required support, and 1 because he was found ineligible; 1 patient withdrew before 6-month assessment because he no longer required support.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8734539/v1/7f6339cddd1667242074b109.png"},{"id":102747779,"identity":"18406f97-a577-4114-a8b3-97b0876dbf06","added_by":"auto","created_at":"2026-02-16 09:05:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":116176,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eOutcomes at Baseline, 3, and 6 months\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNote. The figures show the comparisons of the mean at each time point between two groups for each measure. Mean and 95%CI were reported.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8734539/v1/8b97c8a16c3a165e8e6f96e4.png"},{"id":102750767,"identity":"55be9326-0e9e-4b97-b7ca-fc15a8c28fb1","added_by":"auto","created_at":"2026-02-16 09:22:06","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1746483,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8734539/v1/51a68a3b-d2fb-477b-91d7-5ab0d9dbcc75.pdf"},{"id":102621539,"identity":"7efff2f8-4f2e-471d-bfa3-63972a2a587e","added_by":"auto","created_at":"2026-02-13 16:51:34","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":50784,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix.docx","url":"https://assets-eu.researchsquare.com/files/rs-8734539/v1/6f186ea4d5ef004521b8358f.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect of a Digital Peer Navigation Intervention among Patients after Treatment for Prostate Cancer: A Randomized Controlled Trial","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eProstate cancer is highly prevalent worldwide\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e and affects 1 in 8 Canadian males\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. Although localized prostate cancer has a 5-year disease-free survival rate above 90%\u003csup\u003e2\u003c/sup\u003e, local treatments often result in persistent side effects that diminish quality of life (QOL)\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e, including erectile dysfunction, urinary incontinence, and bowel problems\u003csup\u003e\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Hormonal therapy can cause body feminization, hot flashes, fatigue, loss of libido, osteoporosis, and increased risk of diabetes and cardiovascular disease\u003csup\u003e\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. Many patients report insufficient information, emotional support, and self-management skills\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,10 11\u003c/sup\u003e, as well as barriers to care\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e contributing to unmet supportive care needs\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. A Canadian population-based study found that prostate cancer survivors reported the highest unmet needs of all cancer survivor groups\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePatient navigation is a personalized intervention delivered by clinical, lay, or peer (cancer survivor) navigators that aims to address barriers to care, facilitate timely access to healthcare services, and reduce disparities in outcomes\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. An overview of 61 systematic reviews and 53 primary studies of cancer patient navigation found strong evidence for improved screening rates, timeliness of diagnostic resolution and treatment initiation; emerging evidence for improved patient satisfaction and QOL post-treatment; inconsistent evidence for reduced distress; and potential cost-effectiveness for screening\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePatient navigation may be particularly valuable for men with prostate cancer, given men\u0026rsquo;s general reluctance to seek help\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e and the emasculating effects of prostate cancer treatment\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. However, most patient navigation studies have focused on female patients and female navigators\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. Only five RCTs have examined patient navigation in prostate cancer: four used lay navigators, two incorporated peer navigators\u003csup\u003e\u003cspan additionalcitationids=\"CR22 CR23 CR24\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e and none focused on the post-treatment period. In addition, no RCTs have evaluated technology-based navigation, despite calls from government agencies in the United States\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e, Canada\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e, and Australia\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e to leverage technology in patient navigation to improve equity in cancer care.\u003c/p\u003e \u003cp\u003eIn this study, we evaluated the effect of digital peer navigation on patient-reported outcomes after treatment for prostate cancer. Patients with prostate cancer value support from peers to deal with treatment-related side effects and empower them to be proactive in managing their health\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e. Peer support can improve cancer patients\u0026rsquo; knowledge and self-management self-efficacy, while reducing distress\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e,\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e. Engaging peer navigators is less costly than employing clinical navigators and offers survivors an opportunity to use their expertise and enhance their psychosocial wellbeing\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Based a pilot study\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e, we hypothesized that patients who received digital peer navigation would report higher patient activation (knowledge, skills, and confidence to manage one\u0026rsquo;s health and healthcare)\u003csup\u003e\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e, better QOL, and less supportive care needs.\u003c/p\u003e"},{"header":"PATIENTS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTrial Design\u003c/h2\u003e \u003cp\u003eWe conducted a multi-center, type-1, hybrid effectiveness-implementation study\u003csup\u003e\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e. Here we report on the efficacy of the intervention, evaluated using a phase III pragmatic RCT\u003csup\u003e\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e with an active wait-list control, individual patient randomization, blinded outcome assessment, and embedded process evaluation. We used the PRECIS-2 tool\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e to design the RCT, adopting broad inclusion criteria and recruiting across several clinics. The protocol was approved by institutional ethics boards (UHN #21-5126, UBC #H21-01755 and NSH #1027115) and registered on clinicaltrials.gov (NCT05041504; Sept/13/2021). Reporting followed the CONSORT Extension for Pragmatic Trials\u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants, Settings and Procedures\u003c/h3\u003e\n\u003cp\u003eParticipants were patients diagnosed with localized prostate cancer, who had completed primary treatment\u0026thinsp;\u0026lt;\u0026thinsp;3 months prior, had an active email address or could obtain one, and could read and speak English. Patients were excluded if they were on active surveillance, had metastatic cancer, or were not willing to be randomized.\u003c/p\u003e \u003cp\u003eFrom May/13/2022 to June/26/2024, patients were recruited during regular appointments in the urology and radiation oncology clinics at the Princess Margaret Cancer Centre, University Health Network (UHN; Toronto); the urology and radiation oncology clinics at the Queen Elizabeth II Health Sciences Centre (QEII; Halifax); and the radiation oncology clinic at British Columbia Cancer (BC Cancer; Vancouver). Study information was shared with clinicians and clinic administrators, study posters and postcards were placed in common areas, and clinicians shared postcards with patients. Interested patients were contacted by research staff in-person or by phone.\u003c/p\u003e \u003cp\u003eRandomization was centralized, web-based, generated by REDCAP, and managed by the Department of Biostatistics at UHN. After providing informed consent and completing a baseline questionnaire, eligible patients were randomly allocated in a 1:1 ratio to the intervention or control group and stratified by site using variable block sizes of 2 and 4. Assessments were administered through REDCAP at baseline, 3 and 6 months, with three weekly follow-up reminders, if needed.\u003c/p\u003e\n\u003ch3\u003eStudy Arms\u003c/h3\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eDigital Peer Navigation (intervention)\u003c/h2\u003e \u003cp\u003ePatients in the intervention group received 3 months of digital peer navigation through the PeerNav app (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://peernavigation.truenth.ca/\u003c/span\u003e\u003cspan address=\"https://peernavigation.truenth.ca/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e available as an Apple or Google Play mobile app and via web browsers. After singing-in and answering questions about their diagnosis, sociodemographic profile, and support needs, they viewed the profiles of available peer navigators who matched their criteria and selected a peer navigator. Navigators were trained to 1) assist in identifying needs and overcoming barriers to care; 2) provide practical, informational and emotional support; and 3) encourage a proactive approach to managing health and accessing healthcare. To accomplish these core functions, navigators reviewed patients\u0026rsquo; self-reported needs assessment, established a regular communication schedule (weekly for the first month then bi-weekly), communicated via in-app messaging, video calls, or telephone; and shared resources from the in-app online resource library (ORL). The ORL was a searchable catalogue of curated resources about prostate cancer. For all interactions, navigators used communication guides and documented needs within the app.\u003c/p\u003e \u003cp\u003ePeer navigators were diagnosed with prostate cancer and at least one-year post-treatment. They were recruited through referrals from clinicians and community partners including the Walnut Foundation (Black men\u0026rsquo;s health organization), Prostate Cancer Support Toronto, and Prostate Cancer Support Vancouver and Burnaby, and Blacks in Nova Scotia. They ranged in age, diagnosis (localized/locally advanced), treatments, and race/ethnicity. All completed a proven 8-week, competency-based, online training course\u003csup\u003e\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u003c/sup\u003e, then received supervision from a clinical psychologist through monthly virtual group debriefing sessions. The project team managed real-time supervision and case management.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOnline Resource Library (ORL-control)\u003c/h3\u003e\n\u003cp\u003ePatients in the control group accessed the same ORL via a unique study website. This methodological strong active control condition\u003csup\u003e\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e, accounted for the ORL and digital delivery\u0026rsquo;s effects and reflected usual conditions, given that most prostate cancer patients seek information online\u003csup\u003e\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eTrial End Point\u003c/h2\u003e \u003cp\u003eThe primary outcome was patient activation at 3 months, assessed with the Patient Activation Measure (PAM-13)\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e. This measure evaluates patients\u0026rsquo; knowledge, beliefs, and confidence in managing their health and healthcare\u003csup\u003e\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e. It is a recommended patient-reported outcome for patient navigation\u003csup\u003e\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e, reflects the navigation expectations of patients with prostate cancer (e.g. to be empowered to conduct health-related conversations, ask questions, and proactively cope with treatment side effects)\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e, and is associated with a broad range of health outcomes\u003csup\u003e\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e. The PAM-13 consists of 13 items scored on a 4-point Likert scale, summed, and transformed to 0-100 metric, where higher scores indicate greater activation. A four-point difference in PAM-13 is considered a minimal clinically important difference (MCID)\u003csup\u003e\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOutcome Measures\u003c/h3\u003e\n\u003cp\u003eSecondary exploratory outcomes included QOL, psychosocial wellbeing, supportive care needs, healthcare service use, acceptability, and fidelity. To examine whether effects were maintained, we examined PAM-13 scores at 6 months, which was 3 months after peer navigation concluded. Health-related QOL was measured using the 5-item EQ-5D-5L\u003csup\u003e44\u003c/sup\u003e (transformed score range, 0\u0026ndash;1; 1 represents perfect health; MCID, 0.01\u0026ndash;0.06)\u003csup\u003e\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u003c/sup\u003e. Prostate cancer-specific QOL was measured using the 10-item Patient-Oriented Prostate Utility Scale (PORPUS)\u003csup\u003e\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e\u003c/sup\u003e (transformed score range, 0-100; higher scores indicate better QOL). Anxiety was measured using the 7-item Generalized Anxiety Disorder (GAD-7)\u003csup\u003e47\u003c/sup\u003e (score range 0\u0026ndash;21, higher scores indicate worse anxiety). Depression was measured using the 9-item Patient Health Questionnaire (PHQ-9)\u003csup\u003e48\u003c/sup\u003e (score range, 0\u0026ndash;27; higher scores indicate worse depression). Fear of cancer recurrence was measured with the 9-item Fear of Cancer Recurrence Inventory Short Form (FCR-SF)\u003csup\u003e\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e\u003c/sup\u003e (score range, 0\u0026ndash;36; higher scores indicate worse FCR). Social Support was measured using the 7-item Enriched Social Support Scale (ESSI)\u003csup\u003e\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e\u003c/sup\u003e (score range, 8\u0026ndash;34; higher scores indicate better social support). Supportive care needs were measured using the 34-item Supportive Care Needs Survey Short Form (SCNS-SF34)\u003csup\u003e\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e (transformed score range, 0-100; higher scores indicate higher needs). Resource use was measured using the Health and Social Services Utilization Inventory (HSSUI)\u003csup\u003e\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e\u003c/sup\u003e. A priori hypothesized covariates associated with PAM-13 at 3-months included age, education, income, race/ethnicity, province, treatment, and navigator satisfaction.\u003c/p\u003e \u003cp\u003eAcceptability was assessed by measuring program and navigator satisfaction. Program satisfaction was measured with a 13-item customized program satisfaction measure. Navigator satisfaction was measured with the 9-item Satisfaction with Interpersonal Relationship with Navigator Scale (score range, 9\u0026ndash;45; higher scores indicate higher satisfaction)\u003csup\u003e\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFidelity was assessed by measuring: i) number and medium of patient-navigator interactions extracted from the app and navigator logs; ii) nature of patient-navigator interactions, including needs discussed extracted from the app; and iii) number and type of resources accessed from ORL in the intervention compared to the control group extracted from the app.\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eThe sample size was calculated to detect a six-point between-group difference in the PAM-13 scores at 3 months based on an analysis of covariance (ANCOVA), adjusting for baseline. To achieve 80% power at a 5% significance level, assuming a within-subject correlation of 0.72 and a common standard deviation of 20 based on the pilot study\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e, a total of 100 participants (50 per group) was required. To account for 35% loss to follow-up based on the pilot study, we aimed to recruit 152 patients.\u003c/p\u003e \u003cp\u003eThe primary analysis compared PAM-13 scores at 3 months between the intervention and control groups using ANCOVA, adjusted for baseline. As a sensitivity analysis, multiple imputation was employed to address missing data. The primary intention-to-treat analysis was conducted in accordance with our statistical analysis plan. The PAM-13 scores at 6 months, were analyzed using the similar ANCOVA model adjusted for baseline.\u003c/p\u003e \u003cp\u003eOther secondary analyses were conducted without adjustment for multiplicity, as these were exploratory in nature. Continuous outcomes were compared between groups at each time point using t-tests. Subscale scores with highly skewed distributions were compared at each time point using linear quantile regression at the median. Regression models were used to explore factors associated with the PAM-13 scores at 3 months in the intervention group. We also conducted post hoc exploratory analyses to examine whether the number and duration of patient-navigator interactions were associated with the PAM-13 scores at 3 months in the intervention group. Data management and all statistical analysis were performed using SAS 9.4 (SAS institute Inc., Cary, NC). A two-sided p-value of \u0026lt;\u0026thinsp;0.05 was considered significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eParticipant Characteristics\u003c/h2\u003e \u003cp\u003eOf 664 potentially eligible patients approached, 172 patients were randomized: 86 to the intervention group and 86 to the control group (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Baseline characteristics were balanced between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\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\u003eParticipant Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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 \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll (N\u0026thinsp;=\u0026thinsp;172)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eControl (N\u0026thinsp;=\u0026thinsp;86)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIntervention (N\u0026thinsp;=\u0026thinsp;86)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67.1 (7.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e67.3 (7.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e66.9 (7.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRace/Ethnicity, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsian (East/South)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (5.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlack (African/Caribbean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (5.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (4.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhite (European/North American)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e138 (81.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69 (81.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e69 (82.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (5.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (8.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (3.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePlace of birth, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCanada\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e112 (65.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57 (66.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e55 (63.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e60 (34.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29 (33.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e31 (36.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProvince, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38 (22.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (23.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18 (20.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (5.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (7.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (4.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eON\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e124 (72.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60 (69.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e64 (74.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEducation, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary/Secondary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 (10.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (9.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (12.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCollege/University\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e150 (89.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77 (90.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e73 (87.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHousehold Income\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026lt;=\u003cspan\u003e$\u003c/span\u003e40,000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 (11.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (13.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (10.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cspan\u003e$\u003c/span\u003e40,001-\u003cspan\u003e$\u003c/span\u003e100,000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 (35.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28 (37.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25 (32.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u003cspan\u003e$\u003c/span\u003e100,000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e80 (53.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37 (49.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43 (56.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRelationship status\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarried\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e143 (83.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e67 (77.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76 (88.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSingle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29 (16.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19 (22.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (11.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCancer Diagnosis\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLocalized\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e160 (93.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80 (93.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80 (93.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLocally advanced\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (2.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (4.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDon\u0026rsquo;t know\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (2.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrefer not to answer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (0.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (2.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTreatment\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e107 (62.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50 (58.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e57 (66.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRadiation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e63 (36.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35 (40.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28 (32.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eADT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43 (25.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (27.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20 (23.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eOutcome Measures at baseline (Score Range)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePAM-13\u003c/b\u003e (0-100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77.78 (13.49)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e76.37 (13.01)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e79.19 (13.88)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActivation 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (0.58%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (1.16%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActivation 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (2.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (3.49%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActivation 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e46 (26.74%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31 (36.05%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (17.44%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActivation 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e121 (70.35%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e54 (62.79%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e67 (77.91%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D-5L\u003c/b\u003e (0\u0026ndash;1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.85 (0.11)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.84 (0.10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.85 (0.11)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePORPUS\u003c/b\u003e (0-100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e62.37 (13.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61.51 (13.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e63.23 (13.30)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGAD-7\u003c/b\u003e (0\u0026ndash;21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11.22 (4.43)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.47 (4.74)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10.97 (4.11)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePHQ-9\u003c/b\u003e (0\u0026ndash;27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.23 (4.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.47 (5.12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.99 (3.81)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eESSI\u003c/b\u003e (6\u0026ndash;31)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMean (SD)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.72 (5.80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.02 (6.30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26.41 (5.19)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFCRI-SF\u003c/b\u003e (0\u0026ndash;27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21.67 (6.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.50 (6.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21.84 (6.15)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSCNS-SF34\u003c/b\u003e (0-100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.79 (20.35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29.49 (21.85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24.08 (18.47)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eNote. No missingness was observed in baseline characteristics and baseline outcome measures\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003ePrimary Outcome\u003c/h2\u003e \u003cp\u003eAt 3 months, the adjusted mean PAM-13 score was higher in the intervention group compared to the control group (adjusted mean difference [AMD]\u0026thinsp;=\u0026thinsp;4.41 [95% CI: 0.96, 7.86]; p\u0026thinsp;=\u0026thinsp;0.012). Sensitivity analyses using multiple imputation yielded consistent results (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\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\u003ePAM‑13 scores at 3 and 6 months\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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 \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary Outcome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003eMean (SD) [n]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003eMean (SD) [n]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAdjusted Mean Difference\u003c/p\u003e \u003cp\u003e(95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP Value\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\u003ePAM-13 at 3 months\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e76.49 (12.96) [71]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e84.34 (14.79) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4.41 (0.96, 7.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.012\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePAM-13 at 3 months\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(based on MI)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77.56 (14.38) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e85.14 (15.89) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5.63 (1.20, 10.06)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.013\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePAM-13 at 6 months\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77.15 (14.61) [68]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80.25 (16.64) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.079 (-4.22, 4.07)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.97\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNote. N=available data, the missingness\u0026thinsp;=\u0026thinsp;86-n; Adjusted Mean Difference (AMD) was estimated based on an ANCOVA model for the outcome adjusted for baseline PAM-13. MI: sensitivity analysis for the primary outcome based on multiple imputation (MI) method.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSecondary Outcomes\u003c/h2\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003ePAM-13 and Associated Factors\u003c/h2\u003e \u003cp\u003eAt 6 months, the adjusted mean PAM-13 scores in the intervention and control groups were not significantly different (AMD\u0026thinsp;=\u0026thinsp;0.08 [95% CI: -4.22, 4.06]; p\u0026thinsp;=\u0026thinsp;0.97). Participants who were partnered had higher PAM-13 scores at 3 months compared to those who were single (MD\u0026thinsp;=\u0026thinsp;12.24 [95% CI: 1.12, 23.36]; p\u0026thinsp;=\u0026thinsp;0.031). No other associations were observed (\u003cspan refid=\"Sec25\" class=\"InternalRef\"\u003eAppendix\u003c/span\u003e I, Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eQuality of Life\u003c/h2\u003e \u003cp\u003eAt 3-months, the mean EQ-5D-5L score was higher in the intervention group compared to the control group (MD\u0026thinsp;=\u0026thinsp;0.05 [95% CI: 0.006, 0.09]; p\u0026thinsp;=\u0026thinsp;0.021) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Subscale analysis showed fewer patients with anxiety/depression in the intervention group at 3 months and 6 months (\u003cspan refid=\"Sec25\" class=\"InternalRef\"\u003eAppendix\u003c/span\u003e II). No significant between-group differences were observed in mean PORPUS scores at 3 or 6 months (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\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 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSecondary exploratory outcomes at 3 and 6 months\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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 \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcomes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTime (months)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003eMean (SD) [n]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIntervention Mean (SD) [n]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMean Difference (intervention vs control)\u003c/p\u003e \u003cp\u003e(95%CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP Value\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\u003eEQ-5D\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.85 (0.14) [69]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.90 (0.082) [64]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.05 (0.006, 0.09)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.021\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.86 (0.13) [66]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.88 (0.13) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.02 (-0.025, 0.067)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePORPUS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69.17 (14.91) [71]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e72.57 (11.43) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3.41 (-1.24, 8.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69.55 (14.28) [67]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e72.65 (13.40) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3.10 (-1.78, 8.01)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGAD7\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10.91 (4.94) [70]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e9.54 (4.02) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-1.38 (-2.92, 0.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.08\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10.44 (4.71) [66]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e9.41 (3.91) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-1.03 (-2.56, 0.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.19\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePHQ-9\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12.90 (4.33) [70]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e11.37 (4.57) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-1.53 (-3.05, -0.015)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.048\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12.73 (5.04) [67]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e11.75 (4.11) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-0.99 (-2.62, 0.65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.24\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eESSI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20.85 (10.88) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e20.54 (12.21) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-0.31 (-3.79, 3.17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.86\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e19.19 (11.39) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e18.44 (12.79) [86]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-0.74 (-4.39, 2.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.69\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFCRI-SF\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e17.46 (5.36) [70]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e16.63 (5.32) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-0.83 (-2.65, 0.99)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e21.02 (6.70) [67]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e20.15 (6.08) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-0.86 (-3.13, 1.41)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eSCNS-SF34\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e22.51 (21.71) [70]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e15.21 (17.68) [65]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-7.30 (-14.07, -0.533)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.035\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20.06 (19.27) [67]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13.62 (15.51) [59]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-6.44 (-12.66, -0.22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.043\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eNote. n=available data, the missingness\u0026thinsp;=\u0026thinsp;86-n; The reported p-values were based on comparisons between the two groups using Student t test.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003ePsychosocial Wellbeing\u003c/h2\u003e \u003cp\u003eAt 3 months, the mean PHQ-9 score was lower in the intervention group compared to the control group (MD=-1.53 [95% CI: -3.05, -0.015]; p\u0026thinsp;=\u0026thinsp;0.048) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). No significant between-group differences were observed in mean GAD-7, FCRI-SF, or ESSI scores at 3 months or 6 months, or PHQ-9 score at 6 months.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eSupportive Care Needs\u003c/h2\u003e \u003cp\u003eSCNS-SF34 mean scores were lower in the intervention compared to the control group at 3 months (MD=-7.30 [95% CI: -14.07, -0.533]; p\u0026thinsp;=\u0026thinsp;0.035) and at 6 months (MD=-6.44 [95% CI: -12.66, -0.22]; p\u0026thinsp;=\u0026thinsp;0.043) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Subscale analysis showed reductions in psychological needs at 6 months and patient care/support needs at 3 and 6 months in the intervention group compared to the control group (\u003cspan refid=\"Sec25\" class=\"InternalRef\"\u003eAppendix\u003c/span\u003e III).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eHealthcare Service Use\u003c/h2\u003e \u003cp\u003eAt 3 months, fewer patients in the intervention group had seen other medical specialists outside of routine oncology follow-up visits (e.g. urologist, respirologist, radiotherapist, psychiatrist), compared to the control group (23.44% vs 45.7%, p\u0026thinsp;=\u0026thinsp;0.007). No significant between-group differences were observed in healthcare service use at 6 months.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eAcceptability\u003c/h2\u003e \u003cp\u003eMedian program satisfaction was 9 (IQR\u0026thinsp;=\u0026thinsp;2) (mean 8.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.7), and median navigator satisfaction was 45 (IQR\u0026thinsp;=\u0026thinsp;4) (mean 41.9\u0026thinsp;\u0026plusmn;\u0026thinsp;5.2).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eFidelity\u003c/h2\u003e \u003cp\u003ePatients in the intervention group had mean 5.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4 interactions with their navigator; and 33 (54%) had more than 6 interactions (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Interaction duration was mean 34.5 minutes\u0026thinsp;\u0026plusmn;\u0026thinsp;17.3, and those who had more than 6 interactions had longer interactions (mean 40 minutes\u0026thinsp;\u0026plusmn;\u0026thinsp;19.1). Neither number nor duration of interactions were associated with PAM-13 scores. A total of 458 messages were exchanged on the app. According to navigator reports (n\u0026thinsp;=\u0026thinsp;372), most interactions occurred via in-app messaging (n\u0026thinsp;=\u0026thinsp;148, 38%) or telephone (n\u0026thinsp;=\u0026thinsp;153, 39%), and most needs (n\u0026thinsp;=\u0026thinsp;592) focused on treatment side effects (n\u0026thinsp;=\u0026thinsp;236, 40%). Patients in the control group accessed more resources from the ORL (n\u0026thinsp;=\u0026thinsp;232) than patients in the intervention group (n\u0026thinsp;=\u0026thinsp;137); however, the difference was not significant (3.63\u0026thinsp;\u0026plusmn;\u0026thinsp;6 vs 2.58\u0026thinsp;\u0026plusmn;\u0026thinsp;3, p\u0026thinsp;=\u0026thinsp;0.25).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFidelity and App Usage Data\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\" colname=\"c1\"\u003e \u003cp\u003eItem\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSummary statistic\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFrequency of Interactions\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber of interactions with navigators, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.5 (3.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;6 interactions, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 (46%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;6 interactions, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33 (54%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDuration of Interactions\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInteraction duration (mins), mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (24)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInteraction duration (mins) when \u0026ge;\u0026thinsp;6 interactions, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40 (19.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInteraction duration (mins) when \u0026lt;\u0026thinsp;6 interactions, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30 (14.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedium of Interactions (n\u0026thinsp;=\u0026thinsp;372 interactions logged)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTelephone, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e153 (41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIn-app messaging, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e148 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEmail, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57 (15%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVideo, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (2%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIn-person, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (2%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eIn-app messaging communication\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal messages received by navigators, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e255\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMessages received by navigator, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.8 (7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal messages sent by navigators, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e203\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMessages sent by navigator, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.5 (6.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNeeds Discussed (n\u0026thinsp;=\u0026thinsp;592 needs logged)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSide-effects, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e236 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInformation, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e162 (27%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eState of mind, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e116 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRelationships, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e52 (9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpirituality, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePractical concerns, count (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHealth Resource Library Use\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eIntervention patients\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResources accessed, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.58 (3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal resources accessed, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e137\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnique resources accessed, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eControl patients\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResources accessed, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.63 (6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal resources accessed, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e232\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnique resources accessed, count\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64\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"},{"header":"DISCUSSION","content":"\u003cp\u003eIn this phase III trial, a digital peer navigation intervention improved patient activation and suggested improvements in QOL and reduced depression, and non-oncology specialist use among patients after treatment for prostate cancer, as well as sustained reduction in supportive care needs. These findings contribute to growing evidence on the benefits of patient navigation for cancer patients in the post-treatment survivorship phase of the cancer care continuum.\u003c/p\u003e \u003cp\u003eClinically significant improvements were observed in patient activation and QOL. Patients in the intervention group who were in a relationship reported higher PAM-13 scores, an association that has not been reported previously\u003csup\u003e\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e\u003c/sup\u003e. Partner support may reinforce the effect of a patient activation intervention in men. Higher EQ-5D-5L scores were likely largely due to reduced anxiety/depression subscale scores, which may explain the lack of difference in PORPUS which focuses on physical symptoms. Improvements in physical functioning may require longer peer navigation to master and sustain self-care strategies\u003csup\u003e\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e and access clinically supervised rehabilitation\u003csup\u003e\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e\u003c/sup\u003e. Improvements were also observed in depression, measured by the PHQ-9, but not in anxiety, measured by the GAD-7. The Memorial Anxiety Scale, which assesses prostate cancer-specific anxiety, may be a more sensitive measure in this population\u003csup\u003e\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e\u003c/sup\u003e. Correspondingly, improvements in supportive care needs were likely largely due to reduced needs in the psychological subscale and the patient care/support subscale. The intervention may have had a greater impact on patients\u0026rsquo; psychosocial needs. Support from a peer navigator to address psychosocial needs, may have reduced patients\u0026rsquo; need for non-oncology medical specialty services, potentially resulting in cost-savings.\u003c/p\u003e \u003cp\u003eThe physical effects of prostate cancer and its treatment can be highly distressing\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,5859,\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e\u003c/sup\u003e leading to changes in physical, sexual, and social functioning\u003csup\u003e\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e,\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e\u003c/sup\u003e. Yet, many men are reluctant to seek professional help for these stigmatizing issues\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e and would prefer support from another man who has experienced similar treatment-related side effects\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. Matching patients with trained cancer survivors who have had similar experiences normalizes the experience, provides coping strategies and resource referrals, which can enhance self-efficacy while reducing distress. An RCT of an in-person, one-on-one peer support program for men after a radical prostatectomy similarly observed improvements in self-efficacy and reduced depression\u003csup\u003e\u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFidelity assessment confirmed that the intervention was delivered as intended supporting the internal validity of the findings\u003csup\u003e\u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e64\u003c/span\u003e\u003c/sup\u003e. Patients communicated on average 5.5 times with their navigator (34.5 minutes each) over 3 months and were highly satisfied. Most interactions focused on coping with treatment-related side effects. Neither number nor duration of patient-navigator interactions were associated with PAM-13 scores, indicating that the dose was likely appropriate. Notably, patients in the control group accessed more resources from the ORL, but the difference was not significant. Hence, information alone may not be sufficient to improve these outcomes. These findings have important implications for self-directed navigation interventions, which may be the least-resource intensive form of navigation in a stepped care pathway\u003csup\u003e\u003cspan citationid=\"CR65\" class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eNot all intervention effects were sustained after peer navigation was discontinued. Some degree of skill fade-out or diminishing impacts is the norm for interventions targeting psychological outcomes like skills, capacities, and beliefs\u003csup\u003e\u003cspan citationid=\"CR66\" class=\"CitationRef\"\u003e66\u003c/span\u003e\u003c/sup\u003e. It is also possible that the duration of navigation was insufficient for some people. In Chan\u0026rsquo;s umbrella review of cancer patient navigation, intervention duration ranged from 1 week to 7 years\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. In practice, if a patient still felt they needed navigation, it would not be advisable to discontinue the service. For most patients, the need for navigation would decline over time, but some may require re-entry to navigation services as new needs arise, and others would probably benefit from longer-term service to sustain the benefits. Future research should examine a longer duration of navigation and re-entry to navigation services as needed.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThis study has limitations. Although the overall sample was representative of the Canadian population with respect to the proportion of Black-identifying participants\u003csup\u003e\u003cspan citationid=\"CR67\" class=\"CitationRef\"\u003e67\u003c/span\u003e\u003c/sup\u003e, most patients were white North American/European, and few self-identified with other racial/ethnic backgrounds. Most patients were also college/university educated with high household incomes and high baseline patient activation. While long-standing partnerships with trusted community agencies guided recruitment, more tailored and targeted recruitment strategies are needed to reach a diverse sample\u003csup\u003e68\u003c/sup\u003e. This study was restricted to patients with localized disease; future work should investigate the effect of digital peer navigation among patients with metastatic disease. Some patients withdrew from the intervention due to discomfort with technology. Strategies to engage patients with less technology proficiency may include providing technology support and manually matching patients with navigators by phone. The loss-to-follow-up at 6 months may have reduced the precision of the outcome estimates and potentially introduced bias. The positive results at 3 months for our primary outcome and several secondary outcomes are nonetheless encouraging.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eIn conclusion, digital peer navigation improved patient activation and may improve overall QOL, and reduce depression, supportive care needs and non-oncology medical specialist use in patients after treatment for prostate cancer. Future work should explore how to implement and sustain the effects of digital peer navigation in routine care.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics Approval:\u0026nbsp;\u003c/strong\u003eThe protocol was approved by institutional ethics boards (UHN #21-5126, UBC #H21-01755 and NSH #1027115) in accordance with the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u0026nbsp;\u003c/strong\u003eJLB conceived the project with contributions from all authors; JLB, AK, RU, AM, LM, AV, XYY, ZAL, NP, PWMC, RR, MM, DB, RF, RHH, LJ, AF, JJ contributed to the design of the work; JLB, AK, RU, LM, AV, NP, PWMC, RR, MM, DB, RF, LJ, AF, JJ contributed to the acquisition of the data; JLB, AK, RU, XYY, ZAL, AM, LM, AV, CZ, JJ contributed to the analysis and interpretation of the data; JLB drafted the manuscript and XXY and ZAL prepared the tables; All authors reviewed and edited the draft version of the manuscript; and approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eThis study was funded by the Canadian Institutes of Health Research [#438539]. The funder played no role in study design, data collection, analysis and interpretation of data, or the writing of this manuscript. We would like to acknowledge and thank the Peer Navigators for their participation in and support of the project, and the patients for their time.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u0026nbsp;\u003c/strong\u003eAll authors declare no financial or non-financial competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability:\u0026nbsp;\u003c/strong\u003eData are available upon request from the corresponding author.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003ePresentations:\u0026nbsp;\u003c/strong\u003eThis work has been presented in part at the following conferences: Canadian Association of Psychosocial Oncology (Toronto, 2025) and the Multinational Association for Supportive Care in Cancer (Seattle, 2025).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWang L, Lu B, He M, Wang Y, Wang Z, Du L. 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Validation of the Supportive Care Needs Survey-short form 34 with a simplified response format in men with prostate cancer. \u003cem\u003ePsychooncology\u003c/em\u003e. 2012;21(10):1107-1112. doi:10.1002/pon.2016\u003c/li\u003e\n\u003cli\u003eBrowne G, Roberts J, Gafni A, et al. Economic evaluations of community-based care: Lessons from twelve studies in Ontario. \u003cem\u003eJ Eval Clin Pract\u003c/em\u003e. 1999;5(4):367-385. doi:10.1046/J.1365-2753.1999.00191.X,\u003c/li\u003e\n\u003cli\u003eJean-Pierre P, Fiscella K, Winters PC, et al. Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: A multi-site patient navigation research program study. \u003cem\u003ePsychooncology\u003c/em\u003e. 2012;21(9):986-992. doi:10.1002/pon.2002\u003c/li\u003e\n\u003cli\u003eMcNeely EL, Sachdev R, Rahman R, Zhang B, Skolasky RL. Associations of depression and sociodemographic characteristics with patient activation among those presenting for spine surgery. \u003cem\u003eJ Orthop\u003c/em\u003e. 2021;26:8. doi:10.1016/J.JOR.2021.06.001\u003c/li\u003e\n\u003cli\u003eWennerberg C, Schildmeijer K, Hellstr\u0026ouml;m A, Ekstedt M. Patient experiences of self-care management after radical prostatectomy. \u003cem\u003eEuropean Journal of Oncology Nursing\u003c/em\u003e. 2021;50:101894. doi:10.1016/J.EJON.2020.101894\u003c/li\u003e\n\u003cli\u003eBaumann FT, Zopf EM, Bloch W. Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. \u003cem\u003eSupport Care Cancer\u003c/em\u003e. 2012;20(2):221-233. doi:10.1007/S00520-011-1271-0\u003c/li\u003e\n\u003cli\u003eRoth A, Nelson CJ, Rosenfeld B, et al. 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Depression and prostate cancer: A focused review for the clinician. \u003cem\u003eUrologic Oncology: Seminars and Original Investigations\u003c/em\u003e. 2019;37(4):282-288. doi:10.1016/J.UROLONC.2018.12.020\u003c/li\u003e\n\u003cli\u003eBalderson N, Towell T. The prevalence and predictors of psychological distress in men with prostate cancer who are seeking support. \u003cem\u003eBr J Health Psychol\u003c/em\u003e. 2003;8(Pt 2):125-134. doi:10.1348/135910703321649114\u003c/li\u003e\n\u003cli\u003eCouper JW, Love AW, Duchesne GM, et al. Predictors of psychosocial distress 12 months after diagnosis with early and advanced prostate cancer. \u003cem\u003eMed J Aust\u003c/em\u003e. 2010;193(S5). doi:10.5694/J.1326-5377.2010.TB03930.X\u003c/li\u003e\n\u003cli\u003eWeber BA, Roberts BL, Yarandi H, Mills TL, Chumbler NR, Wajsman Z. The Impact of Dyadic Social Support on Self-Efficacy and Depression After Radical Prostatectomy. \u003cem\u003eJ Aging Health\u003c/em\u003e. 2007;19(4):630-645. doi:10.1177/0898264307300979\u003c/li\u003e\n\u003cli\u003eP\u0026aacute;ez A, Nunan D, McCulloch P, Beard D. The influence of intervention fidelity on treatment effect estimates in clinical trials of complex interventions: a meta-epidemiological study. \u003cem\u003eJ Clin Epidemiol\u003c/em\u003e. 2025;177:111610. doi:10.1016/J.JCLINEPI.2024.111610\u003c/li\u003e\n\u003cli\u003eAgbejule OA, Joseph R, Merchant S, et al. Navigation as a system approach: A qualitative descriptive study to inform a statewide cancer navigation approach in Australia. \u003cem\u003eSupportive Care in Cancer\u003c/em\u003e. 2025;33(3):1-12. doi:10.1007/S00520-025-09201-6/FIGURES/2\u003c/li\u003e\n\u003cli\u003eBailey DH, Duncan GJ, Cunha F, Foorman BR, Yeager DS. Persistence and Fade-Out of Educational-Intervention Effects: Mechanisms and Potential Solutions. \u003cem\u003ePsychol Sci Public Interest\u003c/em\u003e. 2020;21(2):55. doi:10.1177/1529100620915848\u003c/li\u003e\n\u003cli\u003eStatistics Canada. \u003cem\u003eCanada\u0026rsquo;s Black Population: Growing in Number and Diversity.\u003c/em\u003e; 2019. Accessed January 19, 2026: https://www150.statcan.gc.ca/n1/pub/11-627-m/11-627-m2019006-eng.htm\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"npj-digital-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"npjdigitalmed","sideBox":"Learn more about [npj Digital Medicine](http://www.nature.com/npjdigitalmed/)","snPcode":"41746","submissionUrl":"https://submission.springernature.com/new-submission/41746/3","title":"npj Digital Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-8734539/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8734539/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose:\u003c/strong\u003e Patients with prostate cancer (PC) often lack personalized support and self-management skills and face barriers to care when dealing with treatment-related side effects. We examined the effect of digital peer navigation on patient-reported outcomes after treatment for PC.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients and Methods:\u003c/strong\u003e In this phase III trial, conducted in 3 cancer centers in Toronto, Halifax and Vancouver, Canada, patients with localized PC who completed treatment \u0026lt;3 months prior were randomly assigned 1:1 to digital peer navigation or an online resource library (ORL-control). The primary outcome was patient activation (PAM-13; ability to manage one’s health and healthcare) at 3 months. Secondary exploratory outcomes were PAM-13 at 6 months, and quality of life (EQ5D-5L, PORPUS), anxiety (GAD-7), depression (PHQ-9), social support (ESSI), fear of recurrence (FCR-SF), supportive care needs (SCNS-SF34), healthcare use at 3 and 6 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e From May/13/2022 to June/26/2024, 172 eligible patients (mean age 67 ±7.6 years) were randomized. At 3 months, PAM-13 was higher in the intervention compared to ORL-control (adjusted mean difference (AMD)=4.41 [95% CI: 0.96, 7.86]; p=0.012). There were improvements in EQ5D-5L (mean difference (MD)=0.05 [0.006, 0.09]; p=0.021), PHQ-9 (MD=-1.53 [ -3.05, -0.015]; p=0.048), SCNS-SF34 (MD=-7.30 [-14.07, -0.533]; p=0.035) and non-oncology medical specialist use (23.44% vs 45.7%; p=0.007) at 3 months, and SCNS-SF34 (MD=-6.44 [-12.66, -0.22]; p=0.043) at 6 months. Study groups did not differ on PAM-13, EQ5D-5L, or PHQ-9 at 6 months, or the remaining outcomes at 3 or 6 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e Digital peer navigation improved patient activation after PC treatment and may also improve QoL and reduce depression, supportive care needs, and non-oncology medical specialist use. Future work should explore how to implement and sustain the effects of digital peer navigation.\u003c/p\u003e","manuscriptTitle":"Effect of a Digital Peer Navigation Intervention among Patients after Treatment for Prostate Cancer: A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-13 16:51:29","doi":"10.21203/rs.3.rs-8734539/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-04-14T19:51:02+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-13T19:21:36+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-27T22:27:33+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"338610318690644345026706924800765793901","date":"2026-03-23T13:03:32+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"319165977989974713654236373072183560415","date":"2026-03-07T13:14:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"287997637146163756014193300302648688628","date":"2026-03-02T13:17:07+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"296729669989734225789921161523919060375","date":"2026-02-23T08:46:38+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-10T09:06:11+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-10T01:14:38+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-02-09T03:26:53+00:00","index":"","fulltext":""},{"type":"submitted","content":"npj Digital Medicine","date":"2026-01-29T18:30:53+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"npj-digital-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"npjdigitalmed","sideBox":"Learn more about [npj Digital Medicine](http://www.nature.com/npjdigitalmed/)","snPcode":"41746","submissionUrl":"https://submission.springernature.com/new-submission/41746/3","title":"npj Digital Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2843b110-2239-4629-9616-10c02e1a9188","owner":[],"postedDate":"February 13th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[{"id":62839057,"name":"Biological sciences/Cancer"},{"id":62839058,"name":"Health sciences/Health care"},{"id":62839059,"name":"Health sciences/Oncology"},{"id":62839060,"name":"Health sciences/Urology"}],"tags":[],"updatedAt":"2026-04-14T19:54:14+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-13 16:51:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8734539","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8734539","identity":"rs-8734539","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}