Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies.

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.

Primary Care Physician and Urologist Perspectives on Optimizing Active Surveillance for Low-Risk Prostate Cancer.

PURPOSE: We conducted a study to understand primary care physician (PCP) and urologist perspectives on determinants of active surveillance care delivery for men with low-risk prostate cancer. METHODS: We conducted in-depth, semistructured, virtual interviews with a purposive sample of 19 PCPs and 15 urologists between June 2020 and March 2021. We used the behavioral theory-informed Theoretical Domains Framework to understand barriers to and facilitators of active surveillance care delivery. Interviews were recorded, transcribed, and deductively coded into framework domains and constructs by 3 independent coders. Participant recruitment continued until data saturation by group. RESULTS: Our study included 19 PCPs (9 female; 4 in community practices, 15 in academic medical centers) and 15 urologists (3 female; 5 in private practice, 3 in academic medical centers). The most commonly reported Theoretical Domains Framework domains affecting active surveillance care were (1) knowledge and (2) environmental context and resources. Although urologists were knowledgeable about active surveillance, PCPs mentioned limitations in their understanding of active surveillance (eg, what follow-up entails). Both groups noted the importance of an informed patient, especially how a patient's understanding of active surveillance facilitates their receipt of recommended follow-up. Physicians viewed patient loss to follow-up as a barrier, but identified a favorable organizational culture/climate (eg, good communication between physicians) as a facilitator. CONCLUSIONS: With patients increasingly involving their PCPs in their cancer care, our study presents factors both PCPs and urologists perceive (or identify) as affecting optimal active surveillance care delivery. We provide insights that can help inform multilevel supportive interventions for patients, physicians, and organizations to ensure the success of active surveillance as a management strategy for low-risk prostate cancer.

Comparing Patient-reported Functional Outcomes After Radical Prostatectomy in Historical and Contemporary Practice.

PURPOSE: Modifications to surgical technique, particularly the widespread adoption of robotic surgery, have been proposed to improve functional recovery after prostate cancer surgery. However, rigorous comparison of men in historical vs contemporary practice to evaluate the cumulative effect of these changes on urinary and sexual function after radical prostatectomy is lacking. MATERIALS AND METHODS: We compared prospectively collected patient-reported urinary and sexual function from historical (PROSTQA [Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment study], n=235) and contemporary (MUSIC-PRO [Michigan Urological Surgery Improvement Collaborative Patient Reported Outcome] registry, n=1,215) cohorts at the University of Michigan to understand whether modern techniques have resulted in functional improvements for men undergoing prostate cancer surgery. RESULTS: We found significant differences in baseline function, with better urinary (median [IQR]; 100 [93.8-100] vs 93.8 [85.5-100], P < .001) and sexual scores (median [IQR]; 83.3 [66.7-100] vs 74.4 [44.2-87.5], P < .001) prior to treatment in PROSTQA compared to MUSIC-PRO patients, respectively. There was no statistically significant difference in the pattern of urinary incontinence recovery after surgery from 6-24 months between groups (P = .14). However, men in the contemporary MUSIC-PRO group did have significantly better recovery of sexual function compared to men in the historical PROSTQA group (P < .0001). Further, we found that contemporary practice consists of men with more unfavorable demographic and clinical characteristics compared to historical practice. CONCLUSIONS: Our results demonstrate that the widespread alterations in prostate cancer surgery over the past 2 decades have yielded improvements in sexual, but not urinary, function recovery.

Pelvic Recovery After Endometrial Cancer Treatment: Patient-Reported Outcomes and MRI Findings.

RATIONALE AND OBJECTIVES: Most women with endometrial cancer (EC) have an excellent prognosis and may be cured. However, treatment-related pelvic functional impacts may affect long-term quality of life. To better understand these concerns, we explored correlations between patient-reported outcomes and pelvic magnetic resonance imaging (MRI) features in women treated for EC. MATERIALS AND METHODS: Women with histologic diagnosis of EC were consented preoperatively and completed the validated Female Sexual Function Index (FSFI) and Pelvic Floor Dysfunction Index (PFDI) questionnaires at preoperative, 6-week, and 6-month follow-up visits. Pelvic MRIs with dynamic pelvic floor sequences were performed at 6 weeks and 6 months. RESULTS: A total of 33 women participated in this prospective pilot study. Only 53.7% had been asked about sexual function by providers while 92.4% thought they should have been. Sexual function became more important to women over time. Baseline FSFI was low, declined at 6 weeks, and climbed above baseline at 6 months. Hyperintense vaginal wall signal on T2-weighted images (10.9 vs. 4.8, p = .002) and intact Kegel function (9.8 vs. 4.8, p = .03) were associated with higher FSFI. PFDI scores trended toward improved pelvic floor function over time. Pelvic adhesions on MRI were associated with better pelvic floor function (23.0 vs. 54.9, p = .003). Urethral hypermobility (48.4 vs. 21.7, p = .01), cystocele (65.6 vs. 24.8, p < .0001), and rectocele (58.8 vs. 18.8, p < .0001) predicted worse pelvic floor function. CONCLUSION: Use of pelvic MRI to quantify anatomic and tissue changes may facilitate risk stratification and response assessment for pelvic floor and sexual dysfunction. Patients articulated the need for attention to these outcomes during EC treatment.

Implementation of patient-reported outcome measures into health care for men with localized prostate cancer.

Measuring treatment-related quality of life (QOL) has become an increasingly requisite component of delivering high-quality care for patients with prostate cancer. Patient-reported outcome measures (PROMs) have, therefore, become an important tool for understanding the adverse effects of radical prostate cancer treatment and have been widely integrated into clinical practice. By providing real-time symptom monitoring and improved clinical feedback to patients and providers, PRO assessment has led to meaningful gains in prostate cancer care delivery and quality improvement worldwide. By providing an avenue for benchmarking, collaboration and population health monitoring, PROMs have delivered substantial improvements beyond providing individual symptom feedback. However, multilevel barriers exist that need to be addressed before the routine implementation of PROMs is achieved. Improvements in collection, interpretation, standardization and reporting will be crucial for the continued implementation of PROM instruments in prostate cancer pathways.

Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03579680.

Determinants of quality prostate cancer survivorship care across the primary and specialty care interface: Lessons from the Veterans Health Administration.

BACKGROUND: With over 3 million US prostate cancer survivors, ensuring high-quality, coordinated cancer survivorship care is important. However, implementation of recommended team-based cancer care has lagged, and determinants of quality care across primary and specialty care remain unclear. Guided by the theoretical domains framework (TDF), we explored multidisciplinary determinants of quality survivorship care in an integrated delivery system. METHODS: We conducted semistructured interviews with primary (4) and specialty (7) care providers across 6 Veterans Health Administration clinic sites. Using template analysis, we coded interview transcripts into the TDF, mapping statements to specific constructs within each domain. We assessed whether each construct was perceived a barrier or facilitator, examining results for both primary care providers (PCPs) and prostate cancer specialists. RESULTS: Cancer specialists and PCPs identified 2 primary TDF domains impacting their prostate cancer survivorship care: Knowledge and Environmental context and resources. Both groups noted knowledge (about survivorship care) and procedural knowledge (about how to deliver survivorship care) as positive determinants or facilitators, whereas resources/material resources (to deliver survivorship care) was noted as a negative determinant or barrier to care. Additional domains more commonly referenced by cancer specialists included Social/professional role and identity and Goals, while PCPs reported the domain Beliefs about capabilities as relevant. CONCLUSIONS: We used the TDF to identify several behavioral domains acting as determinants of high-quality, team-based prostate cancer survivorship care. These results can inform prostate cancer survivorship care plan content, and may guide tailored, multidisciplinary implementation strategies to improve survivorship care across the primary and specialty care interface.

Psychological Impacts of Male Sexual Dysfunction in Pelvic Cancer Survivorship.

INTRODUCTION: A common negative sequela of cancer treatment in men is sexual dysfunction, which can have a significant psychological impact and can contribute to feelings of depression, anxiety, and other mental health issues. Management of cancer survivors' psychological and mental well-being plays an important role in the treatment and recovery process. AIM: To identify how sexual dysfunction impacts the lives of male cancer survivors and to provide clinicians with treatment recommendations specific to this patient population. METHODS: A total of 51 peer-reviewed publications related to sexual dysfunction in male cancer survivors were selected for analysis. Sources were chosen based on relevance to current cancer therapies, causes and psychological impacts of sexual dysfunction, and treatment recommendations for clinicians caring for cancer survivors. PubMed search terms included "sexual dysfunction," "cancer survivorship," and "male cancer survivors." MAIN OUTCOME MEASURES: Measures of sexual dysfunction were based on cancer survivors reporting inadequate erectile capacity for penetrative sexual intercourse, decreased sensitivity of the genitalia, or inability to enjoy sex. RESULTS AND CONCLUSIONS: Sexual dysfunction was present in male cancer survivors from diverse ages, cancer diagnoses, and treatments of cancer. Many of the men surveyed presented with psychological distress resulting from their posttreatment sexual dysfunction. This had a significant negative impact on their sexual self-esteem, body image, and mental health. Sexual and social development was delayed in survivors of childhood cancer. Healthcare practitioners should initiate conversations with patients regarding the potential for sexual dysfunction at the time of cancer diagnosis and throughout treatment and follow-up. Physical symptoms of sexual dysfunction should be treated, whenever possible, using phosphodiesterase 5 inhibitors or other interventions, and all cancer survivors presenting with psychological distress related to sexual dysfunction should be offered professional counseling. Twitchell DK, Wittmann DA, Hotaling JM, et al. Psychological Impacts of Male Sexual Dysfunction in Pelvic Cancer Survivorship. Sex Med Rev 2019;7:614-626.

De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).

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.

Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer.

PURPOSE: To report sexual health-related quality of life outcomes and utilization and efficacy of sexual aids in a contemporary cohort of patients treated for localized prostate cancer. PATIENTS AND METHODS: Between 2008 and 2013, 471 consecutive men with localized prostate cancer were treated on 2 institutional protocols (NCT01766492, NCT01618851) or on a prospective institutional registry with patient-reported health-related quality of life. All patients were treated with ultra-hypofractionated radiation therapy. Erectile function (EF) was defined as "firm enough for intercourse" with or without aids per Expanded Prostate Cancer Index Composite-26 (n = 222 at baseline); results apply to this cohort unless specifically noted. Sexual aid utilization and efficacy were patient reported. Multivariable analysis of EF was performed. RESULTS: Median follow-up was 60 months, median age was 67 years, and 70% had intermediate- or high-risk disease per National Comprehensive Cancer Network guidelines. At 24 and 60 months, questionnaire response rates were 86% and 67%, and EF was retained in 53% and 41%, respectively. Baseline sexual aid utilization was 37% (n = 82) and was associated with lower 24-month EF preservation on multivariable analysis (adjusted odds ratio 0.49, 95% confidence interval 0.26-0.92). By 60 months, 70% of men had tried aids. Of those who found aids helpful at baseline, 84% to 89% reported continued benefit at 24 to 60 months. Among aid-naïve patients, efficacy was 80% with first-time use within 12 months and 70% more than 12 months after radiation therapy (P = .02). Among men who developed erectile dysfunction but found sexual aids helpful, 25% were not current users at 60 months. CONCLUSIONS: One-third of men used sexual aids at baseline, which doubled by 5 years after radiation therapy. Self-reported efficacy was high and sustained. Despite significant declines in EF, a number of men reported helpfulness of aids but were not active users. Future study is required to understand drivers of aid utilization to optimize posttreatment sexual function.

Negative information-seeking experiences of long-term prostate cancer survivors.

PURPOSE: Many prostate cancer survivors have lasting symptoms and disease-related concerns for which they seek information. To understand survivors' information-seeking experiences, we examined the topics of their information searches, their overall perceptions of the search, and perceptions of their health information seeking self-efficacy (i.e., confidence in their ability to obtain information). We hypothesized that negative search experiences and lower health information seeking self-efficacy would be associated with certain survivor characteristics such as non-white race, low income, and less education. METHODS: This was a retrospective study using data from the Michigan Prostate Cancer Survivor Study (state-based survey of long-term prostate cancer survivor outcomes, N = 2499, response rate = 38 %). Participants recalled their last search for information and reported the topics and overall experience. We conducted multivariable regression to examine the association between survivor characteristics and the information-seeking experience. RESULTS: Nearly a third (31.7 %) of prostate cancer survivors (median age of 76 years and 9 years since diagnosis) reported having negative information-seeking experiences when looking for information. However, only 13.4 % reported having low health information-seeking self-efficacy. Lower income and less education were both significantly associated with negative information-seeking experiences. CONCLUSIONS: Our findings suggest that many long-term prostate cancer survivors have negative experiences when searching for information, and lower income and less education were survivor factors related to negative information-seeking experiences. IMPLICATIONS FOR CANCER SURVIVORS: We advocate for ongoing, information needs assessment at the point-of-care as the survivorship experience progresses to assess and potentially improve survivors' quality of life.

Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research.

INTRODUCTION: More than 70,000 new cases of bladder cancer are diagnosed in the United States annually; with 75% being non-muscle-invasive (NMIBC). Research examining sexual dysfunction in bladder cancer survivors is limited, and previous studies have focused on cystectomy patients. AIMS: To evaluate the impact of sexual dysfunction on NMIBC survivors. METHODS: Mixed-methods data collection integrated a quantitative survey (Study 1; n = 117) and semi-structured qualitative interviews (Study 2; n = 26) from a non-overlapping sample of NMIBC survivors. We performed descriptive and classification and regression tree (CART) analyses of survey data and qualitative analysis of interviews. MAIN OUTCOME MEASURES: Self-reported sexual activity, interest in sex, and physiologic symptoms (e.g., male erectile/ejaculatory difficulties, female vaginal dryness) over the previous 4 weeks; partner communication about sexuality; contamination concerns; illness intrusiveness. RESULTS: Participants in these studies averaged 65 years of age (mean and median) and were male (77%), white (91%), and married (75%). Survey (Study 1) results linked NMIBC treatment to sexual symptoms and relationship issues. Many participants reported sexual inactivity (38.8%). Sexually active participants reported erectile difficulties (60.0%), vaginal dryness (62.5%), and worry about contaminating partner with treatment agents (23.2%). While almost one-half reported the usefulness of talking with partners about sexual function, only one-fifth of participants reported sharing all concerns with their partners. CART analysis supported the importance of communication. One-half of interviewees (Study 2) reported sexual dysfunction. Two-thirds reported negative impacts on their relationships, including perceived loss of intimacy and divorce; over one-third were sexually inactive for fear of contaminating their partner or spreading NMIBC. CONCLUSIONS: Survivors' sexual symptoms may result from NMIBC, comorbidities, or both. These results inform literature and practice by raising awareness about the frequency of symptoms and the impact on NMIBC survivors' intimate relationships. Further work is needed to design symptom management education programs to dispel misinformation about contamination post-treatment and improve quality of life. Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, and Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: Results of cross-sectional mixed-methods research. Sex Med 2014;2:141-151.

Changes in sexual roles and quality of life for gay men after prostate cancer: challenges for sexual health providers.

INTRODUCTION: Gay men with prostate cancer (GMPCa) may have differential health-related quality of life (HRQOL) and sexual health outcomes than heterosexual men with prostate cancer (PCa), but existing information is based on clinical experience and small studies. AIMS: Our goals were to: (i) describe HRQOL and examine changes in sexual functioning and bother; (ii) explore the psychosocial aspects of sexual health after PCa; and (iii) examine whether there were significant differences on HRQOL and sexual behavior between GMPCa and published norms. METHODS: A convenience sample of GMPCa completed validated disease-specific and general measures of HRQOL, ejaculatory function and bother, fear of cancer recurrence, and satisfaction with prostate cancer care. Measures of self-efficacy for PCa management, illness intrusiveness, and disclosure of sexual orientation were also completed. Where possible, scores were compared against published norms. MAIN OUTCOME MEASURES: Main outcome measures were self-reported sexual functioning and bother on the Expanded Prostate Cancer Index. RESULTS: Compared with norms, GMPCa reported significantly worse functioning and more severe bother scores on urinary, bowel, hormonal symptom scales (Ps < 0.015-0.0001), worse mental health functioning (P < 0.0001), greater fear of cancer recurrence (P < 0.0001), and were more dissatisfied with their PCa medical care. However, GMPCa reported better sexual functioning scores (P < 0.002) compared with norms. Many of the observed differences met criteria for clinical significance. Physical functioning HRQOL and sexual bother scores were similar to that of published samples. GMPCa tended to be more "out" about their sexual orientation than other samples of gay men. CONCLUSIONS: GMPCa reported substantial changes in sexual functioning after PCa treatment. They also reported significantly worse disease-specific and general HRQOL, fear of recurrence, and were less satisfied with their medical care than other published PCa samples. Sexual health providers must have an awareness of the unique functional and HRQOL differences between gay and heterosexual men with PCa.

American Cancer Society prostate cancer survivorship care guidelines.

Prostate cancer survivors approach 2.8 million in number and represent 1 in 5 of all cancer survivors in the United States. While guidelines exist for timely treatment and surveillance for recurrent disease, there is limited availability of guidelines that facilitate the provision of posttreatment clinical follow-up care to address the myriad of long-term and late effects that survivors may face. Based on recommendations set forth by a National Cancer Survivorship Resource Center expert panel, the American Cancer Society developed clinical follow-up care guidelines to facilitate the provision of posttreatment care by primary care clinicians. These guidelines were developed using a combined approach of evidence synthesis and expert consensus. Existing guidelines for health promotion, surveillance, and screening for second primary cancers were referenced when available. To promote comprehensive follow-up care and optimal health and quality of life for the posttreatment survivor, the guidelines address health promotion, surveillance for prostate cancer recurrence, screening for second primary cancers, long-term and late effects assessment and management, psychosocial issues, and care coordination among the oncology team, primary care clinicians, and nononcology specialists. A key challenge to the development of these guidelines was the limited availability of published evidence for management of prostate cancer survivors after treatment. Much of the evidence relies on studies with small sample sizes and retrospective analyses of facility-specific and population databases.