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

摘要：本申请是对PA-15-261号文件的响应，该文件名为《通过干预措施改善健康的研究》 性少数群体和性别少数群体的差异“，推动了三个领域的研究。首先，前列腺癌(PCA)是 同性恋、双性恋和其他男男性行为者中第二常见的癌症(GBM)， 有记录的差异，但研究严重不足。因为同性恋性行为不同于阴道性行为， 从生理学上讲，614项针对异性恋男性的研究结果可能不会推广到患有GBM的人群。 PCA。目前还没有专门针对前列腺癌GBM幸存者的康复研究，所以临床医生没有 相关研究，以提供对其GBM患者的最佳实践。其次，大多数PCA研究都测试了一个或多个 康复组件。我们将进行临床实践状态的第一次治疗研究 GBM患者生活质量综合康复计划，包括尿路和性功能 并采取麻烦的措施。第三，几乎所有的PCA研究都集中在最近接受PCA治疗的男性身上。我们会 采用分层设计，对近期治疗(最近2年)和治疗后(2年以上)的基底膜进行研究。 这项研究建立在我们在Restore，an R21中的发现的基础上，这只是GBM与PCA之间的第二次研究 由NCI资助，也是第一个出版的。我们进行了N=41次深入的定性访谈 良好的饱和度，以及迄今为止最大的GBM与PCA的定量研究(N=193)，第一需要 用主成分分析评估基底膜，并首次对基底膜的同性伴侣和照顾者进行研究。参与者 将根治性前列腺切除术描述为使她们“受辱”、“致残”、“不如其他男同性恋者”，以及 “严重抑郁。”大多数人(88%)报告说，持续的性挑战导致生活质量下降， 心理健康状况较差，身份认同面临挑战，主要关系恶化。8个人中只有3个(38%) 作为治疗的一部分，讨论了大多数GBM普遍经历的结果。没有证据表明 任何标准的专业康复；事实上，大多数GBM只是对自己进行治疗。 这项研究的长期目标是改善PCA术后GBM幸存者的健康状况，并提供 康复的证据基础。在AIM I，我们将开发一个为GBM量身定做的在线康复计划 解决了PCA治疗的性影响和尿路影响。在AIM II中，我们将进行比较 招聘研究，以确定最佳方法招募450名GBM与主成分分析。在AIM III中，我们将评估这些影响 关于性和泌尿结果的量身定做的康复计划。我们将进行为期24个月的随机调查 结构化康复与常规护理的对照试验。此RCT将确定结构化的 康复计划有效地解决了前列腺癌引起的主要性问题和尿路问题 治疗。作为第一个集中于前列腺癌的基底膜(以及口腔和肛交)的治疗研究，它解决了 长期存在的健康差距。这项研究具有很高的潜力，可以用PCA改造GBM的康复， 为临床医生提供关键的证据基础，并告知所有PCA幸存者的康复结果。

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.