Abstract Background Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. Methods Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation–Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer (“yes”/“probably yes,” “probably no”/“no”), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. Results Our survey was completed by 84 respondents (13% response rate), with 27% indicating “probably no”/“no” to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity–Social, Motivation–Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. Conclusions Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. Trial registration ClinicalTrials.gov, NCT03579680

Men with prostate cancer are often treated with the suppression of testosterone through long-acting injectable drugs termed chemical castration or androgen deprivation therapy (ADT). In most cases, ADT is not an appropriate treatment for localized prostate cancer, indicating low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel’s Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify behavioral determinants of low-value ADT use to manage localized prostate cancer, and theory-based opportunities for de-implementation strategy development. We used national cancer registry and administrative data from 2016 to 2017 to examine the variation in low-value ADT use across Veterans Health Administration facilities. Using purposive sampling, we selected high- and low-performing sites to conduct 20 urology provider interviews regarding low-value ADT. We coded transcripts into TDF domains and mapped content to the COM-B model to generate a conceptual framework for addressing low-value ADT practices. Our interview findings reflected provider perspectives on prescribing ADT as low-value localized prostate cancer treatment, including barriers and facilitators to de-implementing low-value ADT. We characterized providers as belonging in 1 of 3 categories with respect to low-value ADT use: 1) never prescribe 2); willing, under some circumstances, to prescribe: and 3) prescribe as an acceptable treatment option. Provider capability to prescribe low-value ADT depended on their knowledge of localized prostate cancer treatment options (knowledge) coupled with interpersonal skills to engage patients in educational discussion (skills). Provider opportunity to prescribe low-value ADT centered on the environmental resources to inform ADT decisions (e.g., multi-disciplinary review), perceived guideline availability, and social roles and influences regarding ADT practices, such as prior training. Provider motivation involved goals of ADT use, including patient preferences, beliefs in capabilities/professional confidence, and beliefs about the consequences of prescribing or not prescribing ADT. Use of the TDF domains and the COM-B model enabled us to conceptualize provider behavior with respect to low-value ADT use and clarify possible areas for intervention to effect de-implementation of low-value ADT prescribing in localized prostate cancer. ClinicalTrials.gov , NCT03579680

373 Background: Long term adverse symptoms following treatment for prostate cancer are prevalent and can negatively impact quality of life and increase healthcare seeking, even though many symptoms can be effectively self-managed. There remains a need for tools to support long term survivors to feel confident in their ability to self-manage their symptoms, potentially translating to more efficient health care utilization. Methods: We conducted a RCT of an automated tailored self-management support intervention (vs. newsletter) for long term (> 1 year) Veteran survivors of prostate cancer recruited from 4/2015-2/2017 across four VA sites. Participants were randomized (278 per arm) and assessed via survey at 5 months and 12 months post enrollment. The intervention delivered tailored information regarding symptoms for urinary, sexual, bowel and general health over 3 months, allowing participants to choose focus areas. At 12 months, we assessed secondary trial outcomes; participants’ reports of use of services relative to their symptoms (urinary, bowel, sexual, general health) and their confidence in symptom self-management (scale from 5-15). We also assessed use of procedures and medications related to each symptom area via medical charts. We tested differences in reported and documented service use between arms using T-tests and Chi-square tests. We further assessed participants engagement in components of the intervention. Results: Of those randomized, 81.7% completed the 12-month survey assessment (N = 226 Intervention and N = 228 Control). The average age was 66.7, 28% were Black, and 49% were high school graduates or less. Participants in the intervention arm reported greater confidence in symptom self-management than controls (Mean: 13.5 vs. 12.9; P = 0.01). Intervention participants reported less often using services related to urinary (43.9% vs. 56.0%, P = 0.03) and sexual (42.3% vs. 57.6%, P = 0.04) health over the prior 7 months. Review of intervention paradata found that urinary and sexual health were the topics most frequently engaged with among intervention subjects. No significant differences in medical chart documented procedures related to symptom areas were found. Conclusions: This secondary trial analysis found that 12 months post enrollment, Veterans who engaged with a tailored self-management intervention were more confident in their ability to self-manage their symptoms. The associated finding of fewer visits for the most commonly chosen areas for symptom self-management suggests that such an intervention may hold promise for helping long term survivors to effectively self-manage adverse symptoms. Clinical trial information: NCT01900561.

e17055 Background: Many men with prostate cancer will be exposed to ADT at some point during cancer survivorship. Unfortunately, ADT overuse in low-value scenarios is not uncommon (e.g., monotherapy in localized prostate cancer, biochemically-recurrent non-metastatic disease) resulting in more harms than benefits. We conducted an innovative survey study to unpack ADT overuse to inform behavior change and de-implementation strategies. Methods: Our survey used the Theoretical Domains Framework (TDF), and the Capability, Opportunity, Motivation – Behavior (COM-B) Model. The survey was fielded to the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on their likelihood of stopping ADT monotherapy in the case of a localized prostate cancer patient presenting to their office (yes/probably yes, probably no/no), and characterized Likert scale responses to 7 COM-B statements. We used multivariable logistic regression to identify associations between stopping ADT and COM-B responses across a dichotomized Likert scale of “strongly disagree/disagree/neutral” and “agree/strongly agree.”. Results: Our survey was completed by 84 respondents (13% response rate), with 27% indicating ‘probably no’/‘no’ to stopping low-value ADT monotherapy in the case of a localized prostate cancer patient presenting to their office. Our multivariable model identified 2 COM-B statements significantly associated with lower likelihood of stopping low-value ADT. Conclusions: Using an innovative, behavioral theory-informed survey, we identified that providers less likely to stop low-value ADT had greater concern about patient worry and were more interested in providing ADT recommendations consistent with peers, informing de-implementation strategy selection. Clinical trial information: MCT03579680. [Table: see text]

PURPOSE This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.

BACKGROUND:Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial.METHODS/DESIGN:This innovative mixed methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the theoretical domains framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies.DISCUSSION:Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring.TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03579680 , First Posted July 6, 2018.

5011 Background: The purpose of this randomized trial was to compare a personally-tailored symptom management intervention consisting of 4 automated telephone assessments and tailored education for improving symptom self-management among prostate cancer survivors to usual care (1 non-tailored newsletter about symptom management). We hypothesized improved symptom self-management and prostate cancer quality of life following the intervention. Methods: A total of 556 prostate cancer survivors experiencing symptom burden were recruited from April 2015 to February 2017 across 4 sites. Participants were randomized to intervention (n = 278) and usual care (n = 278) groups as reported in our protocol. Our primary outcome was symptom burden assessed via patient report 5 months after enrollment using the EPIC-26 instrument. Secondary outcomes included psychosocial outcomes and domain-specific changes according to intervention participants’ primary symptom area (urinary, bowel, sexual, general). We used multivariable regression analysis to evaluate intervention impact on outcomes. Results: The mean age of prostate cancer survivors was 66.7 years and the majority was treated with radiation therapy (56.7% vs. 46.2% surgery). The 5 month primary outcome assessment was completed by 89% of participants. There were no baseline differences across groups. At 5 months, we observed differences between groups in urinary domains (irritative - 61.8 control vs. 63.4 intervention, adjusted mean difference (aMD) 2.6, p = 0.07; obstructive - 74.5 control vs. 77.4 intervention, aMD 2.6, p = 0.07) with no significant differences in other outcomes. Intervention participants choosing urinary (crude mean difference (cMD) irritative 3.0; p = 0.09, obstructive 6.1; p < 0.01), bowel (cMD 9.1; p = 0.08), and sexual (cMD 5.6; p < 0.01) domains as their primary focus area reported improvements at 5 months. Participants reported high satisfaction with the intervention. Conclusions: A personally-tailored, automated telephone symptom management intervention for prostate cancer survivors was feasible and led to differences in urinary and sexual health symptoms in this randomized trial. Self-management of treatment-related side effects appears warranted. Clinical trial information: NCT01900561.

Although prostate cancer is the most common cancer among veterans receiving care in the Veterans Health Administration (VA), more needs to be done to understand and improve survivorship care for this large population. This study, funded by VA Health Services Research & Development (HSR&D), seeks to address the need to improve patient-centered survivorship care for veterans with prostate cancer.

BACKGROUND:Chronic back pain is a significant problem worldwide and may be especially prevalent among patients receiving care in the U.S. Department of Veterans Affairs healthcare system. Back pain affects adults at all ages and is associated with disability, lost workplace productivity, functional limitations and social isolation. Exercise is one of the most effective strategies for managing chronic back pain. Yet, there are few clinical programs that use low cost approaches to help patients with chronic back pain initiate and maintain an exercise program.METHODS/DESIGN:We describe the design and rationale of a randomized controlled trial to assess the efficacy of a pedometer-based Internet mediated intervention for patients with chronic back pain. The intervention uses an enhanced pedometer, website and e-community to assist these patients with initiating and maintaining a regular walking program with the primary aim of reducing pain-related disability and functional interference. The study specific aims are: 1) To determine whether a pedometer-based Internet-mediated intervention reduces pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe. 2) To assess the effect of the intervention on walking (measured by step counts), quality of life, pain intensity, pain related fear and self-efficacy for exercise. 3) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients randomized to the intervention.DISCUSSION:Exercise is an integral part of managing chronic back pain but to be effective requires that patients actively participate in the management process. This intervention is designed to increase activity levels, improve functional status and make exercise programs more accessible for a broad range of patients with chronic back pain.TRIAL REGISTRATION NUMBER:NCT00694018.