|Grant Number:||5R21CA137434-02 Interpret this number|
|Primary Investigator:||Duhamel, Katherine|
|Organization:||Sloan-Kettering Inst Can Research|
|Project Title:||Increasing the Sexual Health of Male Rectal Cancer Patients: a Pilot Study|
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.