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NCT number NCT03420547
Study type Interventional
Source Duke-NUS Graduate Medical School
Contact Irene Teo, Ph.D.
Phone +65-660-15145
Status Not yet recruiting
Phase N/A
Start date February 2018
Completion date January 2020

Clinical Trial Summary

Disturbances in marital intimacy and sexual health is one of the most underrated and undertreated problems in cancer survivorship. A review on unmet supportive care needs of cancer patients noted one third to more than half of patients reported support for sexual disturbances as an area of unmet need during and after treatment. Patients, whose sense of femininity and body image may be at risk, such as in the case of breast and gynaecologic cancers, may be more susceptible to such intimacy and sexual disturbances. According to a recent study conducted in Singapore, 25% of gynaecologic cancer patients reported dissatisfaction with their bodies and 19% reported feeling less sexually attractive. Unfortunately, there is paucity in formal resources for couples counselling within the oncology setting in Singapore. The current study seeks to investigate a pilot program called Renewing Intimacy and Sexuality (RISE), which consists of 3 sessions with female cancer patients and their spouses, and that combine components of psychosexual education, communication training and skills building. The reach, acceptability, implementation, and preliminary effectiveness of the RISE program will be assessed based on the RE-AIM framework for program planning. The overall aim of the research project is to establish evidence-based programs for cancer survivors to enhance their quality of life.

Clinical Trial Description

This is a multi-site, randomized controlled, pilot intervention study. Patients seen in outpatient clinics in the Department of Gynaecologic Oncology at KKH Women and Children's Hospital (KKH) and the breast team within the Division of Medical Oncology at National Cancer Centre (NCC) will be recruited to participate. Patients who meet pre-screen criteria will be invited to complete a self-report screener of marital and sexual well-being. Those who are eligible for the study and indicate interest will be contacted to participate in the RISE program. Study participants will sign an informed consent before being given a pre-treatment assessment and being randomized using an opaque, sealed envelope system to receive either (i) the RISE program or (ii) Standard Care. Those in the Standard Care group will have the option of participating in the RISE program after their second pre-treatment assessment to ensure all participants are given the opportunity to receive the program. Randomization is stratified by cancer (i.e., gynaecologic vs breast) and occur in permuted blocks. At the end of participation in the RISE program, all participants will be given a post-treatment assessment. Spouse of the participants will be invited to participate in the study. Those who agree will complete a pre-treatment survey similar to the patient participant and attend the 3 sessions with the patient, and complete a post-treatment assessment similar to the patient's.

The RISE Intervention consists of 3 sessions which will last 2 hours each and be conducted with a clinical psychologist or medical social worker with experience with couples counseling. The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.

Study Design

Related Conditions & MeSH terms

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