NCT00712751

The Sexual Health of Rectal Cancer Patients

The Sexual Health of Rectal Cancer Patients: a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 192 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn: * How the treatment affects emotional and social well-being. * How a new sexual health educational program affects you. Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.

Detailed description

This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer. We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).

Conditions

• Rectal Cancer
• Rectum

Interventions

Type	Name	Description
BEHAVIORAL	questionnaires	Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
BEHAVIORAL	CSI-SH- Cancer Survivorship Intervention	This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.

Timeline

• Start date: 2008-06-24
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2008-07-10
• Last updated: 2024-11-26

Locations

2 sites across 1 country: United States