The Sexual Rehabilitation of Rectal Cancer Survivors: A Pilot Study

描述（由申请人提供）：2006年将有超过18,350例女性直肠癌（RC）被诊断出来。在过去的20年里，随着手术技术的进步，RC的治疗方法得到了迅速的改善，从而提高了生存率，减少了局部复发。因此，幸存者问题变得越来越重要。一个令人不安的问题是，在接受RC治疗后，女性的性功能明显受损。本研究的目的是开发和试验一种新的、以性健康为重点的干预措施，旨在提高女性癌症幸存者的存活率，名为“癌症幸存者干预-性康复（CSI-SR）”。CSI-SR的目的是根据女性RC幸存者的需求和偏好来减少性问题。这项早期研究将以随机对照试验（RCT）为特色，将116名RC幸存者分层并随机分配到两种情况之一：1)CSI-SR加常规护理（UC）或2)仅UC。被分配到CSI-SR +UC的患者将接受四次面对面的治疗，每两个月一次。每次会议的重点是不同的主题，包括关于生殖健康治疗对性健康影响的教育、一般的痛苦应对战略和增进性健康的具体战略（参议院重点）。每节课还包括家庭作业，要在中间的一周内完成。此外，前三个面对面的会议之后是一个助推器/故障排除电话会议，以帮助参与者制定战略和解决实施中的任何障碍。这些助推器电话将作为策略练习的提醒。无论被分配到何种状态，所有参与者将在基线时进行三次评估，然后在基线后2个月和4个月再次进行评估。该试验性随机对照试验的目的有三个：1)调查CSI-SR对RC幸存者性功能主要结局的可行性、耐受性、可接受性和前景；2)探讨CSI-SR对性自我概念、癌症特异性痛苦、一般痛苦和生活质量等次要结局的影响；3)探索可能影响CSI-SR有效性的变量（即调节因子）。这项试点研究提供的信息将为采取干预措施提高艾滋病幸存者的性健康提供信息。该研究具有很高的翻译前景。如果发现CSI-SR有效，可以很容易地应用于临床护理。在进行试点随机对照试验之前，将进行三个焦点小组，每个小组有10名RC幸存者。研究小组成员和先前的研究人员发现焦点小组是告知干预措施发展的一种极好的方式，以确保干预措施与目标人群的需求相匹配。这三个焦点小组将确保CSI- SR针对RC幸存者的需求和偏好。虽然直肠癌治疗可以挽救生命，但对幸存者来说，性健康方面的费用很高。结直肠癌是癌症死亡的第三大原因。虽然直肠癌幸存者的数量可能少于结肠癌幸存者，但我们的研究表明，女性直肠癌幸存者比女性结肠癌幸存者遭受更多的性健康问题。CSI-SR旨在解决这一重大的幸存者问题，根据他们的需求和偏好，为RC幸存者提供简短的干预措施，以促进性健康。

DESCRIPTION (provided by applicant): Over 18,350 cases of rectal cancer (RC) will be diagnosed in women in 2006. Therapy for RC has rapidly improved with advances in surgical techniques resulting 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 women after RC therapy is significantly impaired. The goal of the proposed study is to develop and pilot a novel, sexual health focused intervention designed to enhance female RC survivorship entitled, "Cancer Survivorship Intervention-Sexual Rehabilitation (CSI-SR). CSI-SR is designed to reduce sexual problems based on the needs and preferences of female RC survivors. This early stage study will feature a randomized controlled trial (RCT) with 116 RC survivors stratified and randomly assigned to one of two conditions: 1) CSI-SR plus usual care (UC) or 2) UC only. Patients assigned to CSI-SR +UC will receive four face-to-face bimonthly sessions of this novel intervention. Each session focuses on different topics including education about the impact of RC treatment on sexual health, general distress coping strategies and specific strategies to increase sexual health (senate 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/trouble shooting telephone session to help participants enact the strategies and problem solve any barriers to implementation. These booster phone calls will serve as reminders for strategy practice. Regardless of assignment to condition, all participants will be assessed three times, at baseline and then again 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-SR on the primary outcome of RC survivors sexual functioning; 2) To investigate the impact of CSI-SR on secondary outcomes: sexual self concept, cancer specific distress, general distress, and quality of life; and 3) To explore variables that may influence the effectiveness of CSI-SR (i.e., moderators). Information from this pilot study will inform the use of interventions to increase sexual health among RC survivors. This study has high translational promise. If CSI-SR is found to be efficacious, it could be easily adopted into clinical care. Prior to conducting the pilot RCT, three focus groups will be conducted with 10 RC survivors each. Focus Groups have been found by members of the research team and prior researchers to be an excellent way to inform intervention development to ensure that the intervention is matched to the needs to the target population. The three focus groups will ensure that CSI- SR is targeted to the needs and preferences of RC survivors. to public health 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, our research has suggested that female RC survivors suffer more sexual health problems as compared to female colon cancer survivors. CSI-SR is deigned to address this significant survivorship issues by providing a brief intervention to promote sexual health designed for RC survivors based on their needs and preferences.