Increasing the Sexual Health of Male Rectal Cancer Patients: A Pilot Study

描述(申请人提供)：每年有超过23,000例直肠癌(RC)在男性中被诊断出来。在过去的20年里，RC的治疗方法的进步提高了存活率，减少了局部复发。因此，生存问题变得越来越重要。一个令人担忧的问题是，RC治疗后男性的性功能可能会显著受损。这项拟议研究的目标是开发和试验一种新的、以性健康为重点的干预措施，旨在提高男性RC存活率，标题为“癌症生存干预-男性性健康(CSI-SH-M)”。CSI-SH-M旨在根据男性RC幸存者的需求和偏好减少性问题。这项早期研究将采用随机对照试验(RCT)，将68名男性RC幸存者按是否存在永久吻合口进行分层，并随机分配到以下两种情况之一：1)CSI-SH-M加常规护理(UC)或2)仅UC。被分配到CSI-SH-M+UC的患者将接受这一新型干预的四次面对面会议。每期课程侧重于不同的主题，包括关于RC治疗对性健康的影响的教育、减少痛苦的应对策略和增强性健康的具体策略(例如，感觉焦点)。每堂课还包括要在其间的一周内完成的家庭作业。此外，在前三次面对面会议之后，还将举行一次助推器/故障排除电话会议，以帮助参与者制定战略并解决实施中的任何障碍。这些助推器电话也将作为战略实践的提醒。无论条件如何，所有参与者都将接受三次评估：基线、基线后两个月和四个月。拟议的随机对照试验的目的有三个：1)调查CSI-SH-M对RC幸存者性功能的主要结果的可行性、耐受性、可接受性和承诺；2)调查CSI-SH-M对次级结果的影响：性困扰、性自我图式、认知加工、癌症特异性苦恼、一般苦恼和生活质量；以及3)探索可能影响CSI-SH-M有效性的变量(即调节者)。来自这项初步研究的信息将为使用干预措施来提高男性RC幸存者的性健康提供信息。这项研究具有很高的翻译前景。如果CSI-SH-M被发现是有效的，它可以很容易地被应用于临床护理。在开展区域工作队试点之前，将进行10次个别定性访谈和3个重点小组。研究小组成员和以前的研究人员发现，个别定性访谈和焦点小组是确保干预措施与目标人群的需求相匹配的极好方式。公共卫生相关性：虽然挽救了生命，但直肠癌(RC)治疗对幸存者来说在性健康方面可能会有很高的成本。结直肠癌是导致癌症死亡的第三大原因。尽管RC幸存者的数量可能比结肠癌幸存者少，但研究表明，与男性结肠癌幸存者相比，RC男性幸存者遭受更多的性健康问题。CSI-SH-M旨在解决这一重大的生存问题，根据男性RC幸存者的需求和偏好，提供简短的干预措施，以促进他们的性健康。

DESCRIPTION (provided by applicant): Over 23,000 cases of rectal cancer (RC) are diagnosed in men annually. Advances in therapy for RC have resulted in improved survival and decreased local recurrence over the last 20 years. As a result survivorship issues have become increasingly important. A troubling issue is that sexual function in men after RC treatment can be significantly impaired. The goal of the proposed study is to develop and pilot a novel, sexual health focused intervention designed to enhance male RC survivorship entitled, "Cancer Survivorship Intervention- Sexual Health for Men (CSI-SH-M)." CSI-SH-M is designed to reduce sexual problems based on the needs and preferences of male RC survivors. This early stage study will feature a randomized controlled trial (RCT) with 68 male RC survivors stratified by the presence or absence of permanent stoma and randomly assigned to one of two conditions: 1) CSI-SH-M plus usual care (UC) or 2) UC only. Patients assigned to CSI-SH-M +UC will receive four face-to-face sessions of this novel intervention. Each session focuses on different topics including education about the impact of RC treatment on sexual health, coping strategies for reducing distress and specific strategies to increase sexual health (e.g., sensate focus). Each session also includes homework assignments to be completed within the intervening week. In addition, the first three face-to-face sessions are followed by a booster/troubleshooting telephone sessions to help participants enact the strategies and problem solve any barriers to implementation. These booster phone calls will also serve as reminders for strategy practice. Regardless of condition assignment, all participants will be assessed three times: at baseline, and two and four months post-baseline. The purpose of the proposed pilot RCT is threefold: 1) To investigate the feasibility, tolerability, acceptability, and promise of CSI-SH-M on the primary outcome of RC survivors' sexual functioning; 2) To investigate the impact of CSI-SH-M on secondary outcomes: sexual bother, sexual self- schema, cognitive processing, cancer specific distress, general distress, and quality of life; and 3) To explore variables that may influence the effectiveness of CSI-SH-M (i.e., moderators). Information from this pilot study will inform the use of interventions to increase sexual health among male RC survivors. This study has high translational promise. If CSI-SH-M is found to be efficacious, it could be easily adopted into clinical care. Prior to conducting the pilot RCT, 10 individual qualitative interviews and three focus groups will be conducted. Individual qualitative interviews and focus groups have been found by members of the research team and prior researchers to be an excellent way to ensure that the intervention is matched to the needs of the target population. PUBLIC HEALTH RELEVANCE: Although life saving, Rectal Cancer (RC) treatment can have a high cost to survivors in regard to their sexual health. Colorectal cancer is the third leading cause of cancer death. Although RC survivors may be fewer in number than colon cancer survivors, research has suggested that male RC survivors suffer more sexual health problems as compared to male colon cancer survivors. CSI-SH-M is designed to address this significant survivorship issues by providing a brief intervention to promote sexual health designed for male RC survivors based on their needs and preferences.