Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors

恢复：改善同性恋和双性恋前列腺癌幸存者的性结果

• 批准号: 10206046
• 负责人: B R Simon Rosser
• 金额: $ 58.01万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10206046
• 关键词: Address; Aftercare; Anal Sex; Area; Bisexual; Bladder Control; Caregivers; Clinic; Communities; Depressed mood; Exercise; Funding; Gays; Gold; HIV Infections; HIV Seropositivity; Health; Health Status; Heterosexuals; Intervention; Intervention Trial; Interview; Knowledge; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Mental Health; Methods; Monitor; Needs Assessment; Operative Surgical Procedures; Oral Sex; Outcome; Participant; Patients; Pelvic floor structure; Pharmaceutical Preparations; Physiological; Population; Prostate Cancer therapy; Publications; Quality of life; Radical Prostatectomy; Randomized Controlled Trials; Rehabilitation Outcome; Rehabilitation therapy; Reporting; Research; Research Methodology; Science; Sex Functioning; Sexual Dysfunction; Sexual and Gender Minorities; Social support; Source; Structure; Survivors; Testing; Time; Urinary Incontinence; Vacuum Pumps; Vagina; Work; arm; base; biopsychosocial; clinical practice; community center; comparative; condoms; demographics; design; evidence base; experience; health disparity; improved; interest; man; men; men who have sex with men; primary outcome; programs; prostate cancer survivors; recruit; rehabilitative care; response; routine care; same-sex partnership; sex; standard of care; three-arm study; treatment center; treatment effect; treatment program; urinary; web site

Abstract: This application, in response to PA-15-261, “Research leading to interventions to ameliorate health disparities of sexual and gender minorities”, advances research in three areas. First, prostate cancer (PCa) is the second most common cancer among gay, bisexual, and other men who have sex with men (GBM), with documented disparities, yet it is severely under-researched. Because gay sex differs from vaginal sex, physiologically; the results from 614 studies focused on heterosexual men likely do not generalize to GBM with PCa. There have been no rehabilitation studies specific to GBM survivors of PCa, so clinicians have no relevant studies to inform best practice with their GBM patients. Second, most PCa studies have tested one or rehabilitation components. We will conduct the first treatment study of a state of clinical practice comprehensive rehabilitation program on GBM's quality of life, including on both urinary and sexual function and bother measures. Third, almost all PCa studies have focused on men recently treated for PCa. We will study both GBM recently treated (last 2 years) and GBM post-treatment (2+ years), using a stratified design. This study builds on our findings in Restore, an R21 which was only the second study of GBM with PCa to be funded by NCI, and the first to reach publication. We conducted N=41 in-depth qualitative interviews with good saturation, and the largest quantitative study of GBM with PCa to date (N=193), the first needs assessment of GBM with PCa, and the first study of same sex partners and care-givers of GBM. Participants described radical prostatectomy as leaving them “humiliated,” “maimed”, “less than other gay men,” and “severely depressed.” Most (88%) reported ongoing sexual challenges contributing to decreased quality of life, poorer mental health, identity challenges and deteriorated primary relationships. Only three of the eight (38%) outcomes commonly experienced by most GBM were discussed as part of treatment. There was no evidence of any standard of professional rehabilitation; indeed, most GBM just treated themselves. The long-term objective of this research is to improve the health of GBM survivors of PCa and to provide an evidence base for rehabilitation. In Aim I, we will develop an online rehabilitation program tailored for GBM that addresses both the sexual and urinary effects of PCa treatment. In Aim II, we will conduct a comparative recruitment study to identify best methods to recruit 450 GBM with PCa. In Aim III, we will evaluate the effects of the tailored rehabilitation program on sexual and urinary outcomes. We will conduct a 24 month, randomized controlled trial of structured rehabilitation versus routine care. This RCT will identify whether a structured rehabilitation program is effective in addressing the major sexual and urinary problems caused by PCa treatment. As the first treatment study to focus on GBM with PCa (and also on oral and anal sex), it addresses a long-standing health disparity. The study has high potential to transform rehabilitation for GBM with PCa, provide a critical evidence base for clinicians, and inform rehabilitation outcomes for all PCa survivors.

摘要：本申请响应 PA-15-261，“改善健康干预措施的研究” 性别少数群体的差异”，推进了三个领域的研究。首先，前列腺癌（PCa）是 同性恋、双性恋和其他男男性行为者 (GBM) 中第二常见的癌症 记录了差异，但研究严重不足。因为同性性行为不同于阴道性行为， 生理上； 614 项针对异性恋男性的研究结果可能无法推广到 GBM 前列腺癌。目前还没有专门针对 PCa 的 GBM 幸存者的康复研究，因此临床医生没有 相关研究为 GBM 患者提供最佳实践。其次，大多数 PCa 研究都测试了一项或多项 康复组件。我们将进行首次临床实践治疗研究 针对 GBM 生活质量（包括泌尿和性功能）的综合康复计划 并打扰措施。第三，几乎所有 PCa 研究都集中在最近接受 PCa 治疗的男性。我们将 使用分层设计研究最近治疗的 GBM（过去 2 年）和治疗后的 GBM（2 年以上）。 这项研究建立在我们在 Restore 中的研究结果的基础上，Restore 是一项 R21，这只是 GBM 与 PCa 的第二项研究 由 NCI 资助，并且第一个发表。我们进行了 N=41 次深度定性访谈 良好的饱和度，以及迄今为止最大规模的 GBM 与 PCa 的定量研究（N=193），首先需要 GBM 与 PCa 的评估，以及对 GBM 的同性伴侣和照顾者的首次研究。参加者 描述根治性前列腺切除术让他们“受到羞辱”、“致残”，“比其他男同性恋者少”，并且 “严重抑郁。”大多数人（88%）报告持续的性挑战导致生活质量下降， 心理健康状况较差，身份认同受到挑战，主要关系恶化。八个中只有三个 (38%) 作为治疗的一部分，讨论了大多数 GBM 常见的结果。没有证据 任何专业康复标准；事实上，大多数GBM只是对待自己。 这项研究的长期目标是改善 PCa 的 GBM 幸存者的健康，并提供 康复的证据基础。在目标 I 中，我们将开发一个针对 GBM 量身定制的在线康复计划， 解决 PCa 治疗对性和泌尿系统的影响。在目标二中，我们将进行比较 招募研究以确定用 PCa 招募 450 GBM 的最佳方法。在目标III中，我们将评估效果 关于性和泌尿结果的定制康复计划。我们将进行为期 24 个月的随机 结构化康复与常规护理的对照试验。该随机对照试验将确定是否存在结构化 康复计划可有效解决 PCa 引起的主要性和泌尿问题 治疗。作为第一项关注 GBM 合并 PCa（以及口交和肛交）的治疗研究，它解决了 长期存在的健康差距。该研究具有很大潜力改变 GBM 合并 PCa 的康复， 为临床医生提供重要的证据基础，并为所有前列腺癌幸存者提供康复结果信息。

项目成果

Health Disparities of Sexual Minority Patients Following Prostate Cancer Treatment: Results From the Restore-2 Study.

• DOI: 10.3389/fonc.2022.812117
• 发表时间: 2022
• 期刊: Frontiers in oncology
• 影响因子: 4.7
• 作者: Rosser BRS;Polter EJ;Talley KMC;Wheldon CW;Haggart R;Wright M;West W;Mitteldorf D;Ross MW;Konety BR;Kohli N
• 通讯作者: Kohli N

Recruiting an underserved, difficult to reach population into a cancer trial: Strategies from the Restore-2 Rehabilitation Trial for gay and bisexual prostate cancer patients.

• DOI: 10.1177/17407745221077678
• 发表时间: 2022-06
• 期刊: CLINICAL TRIALS
• 影响因子: 2.7
• 作者: Rosser, B. R. Simon;Wright, Morgan;Hoefer, Chris J.;Polter, Elizabeth J.;Kohli, Nidhi;Wheldon, Christopher W.;Haggart, Ryan;Mc Talley, Kristine;Mitteldorf, Darryl;Kilian, Gunna;Konety, Badrinath R.;Ross, Michael W.;West, William
• 通讯作者: West, William

The Challenge of Coming Out to Providers by Gay and Bisexual Men With Prostate Cancer: Qualitative Results from the Restore Study.

• DOI: 10.1080/19317611.2021.1924335
• 发表时间: 2021
• 期刊: INTERNATIONAL JOURNAL OF SEXUAL HEALTH
• 影响因子: 2
• 作者: West, William;Torres, Maria Beatriz;Mitteldorf, Darryl;Capistrant, Benjamin D.;Konety, Badrinath R.;Polter, Elizabeth;Rosser, B. R. Simon
• 通讯作者: Rosser, B. R. Simon

Creation and Psychometric Validation of the Sexual Minorities and Prostate Cancer Scale (SMACS) in Sexual Minority Patients-The Restore-2 Study.

• DOI: 10.1016/j.jsxm.2021.12.012
• 发表时间: 2022-03
• 期刊: The journal of sexual medicine
• 作者: Polter EJ;Kohli N;Rosser BRS;Talley KMC;Wheldon CW;Hoefer CJ;Wright M;Haggart R;Mitteldorf D;Kilian G;Konety BR;Ross MW;West W
• 通讯作者: West W