|Grant Number:||5R21CA129195-02 Interpret this number|
|Primary Investigator:||Duhamel, Katherine|
|Organization:||Sloan-Kettering Inst Can Research|
|Project Title:||The Sexual Rehabilitation of Rectal Cancer Survivors: a Pilot Study|
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.