Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050


Protocol of a Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer

Catherine C Classen, Agata Drozd, Lori A Brotto, Lisa Barbera, Jeanne Carter, Meredith L Chivers, John Koval, John W Robinson, Sara Urowitz, David Wiljer and Sarah E Ferguson

Objective: To demonstrate the efficacy of a 12-week, professionally-facilitated, Internet-based support group for women who are sexually distressed due to gynaecologic cancer and its treatment.

Methods: The participants are women who received treatment for gynaecologic cancer, were diagnosed within the previous five years and who currently have no evidence of disease. They must meet a minimum cut-off score on the Revised Female Sexual Distress Scale (FSDS-R). Enrolled participants are randomized to the immediate treatment condition or to the waitlist control condition. The intervention is delivered in an asynchronous format (i.e., bulletin board), and also includes two scheduled synchronous (i.e., live chat) sessions. Each week, a new topic relating to sexuality and gynaecologic cancer is introduced, and group members are given access to psych educational materials on that topic. Assessments are completed at baseline, month 5, and month 9. The primary outcome is sexual distress, and the secondary outcomes include sexual function, body image, depression and anxiety, relationship satisfaction, and perceived social support.

Results: To date, 234 of the planned 520 participants have been enrolled and 7 groups (4 immediate treatments and 3 waitlist) have been conducted.

Conclusion: Women treated for gynaecologic cancer often experience psychosexual distress. Demonstrating the efficacy of an online intervention that targets those concerns is an important step towards meeting the needs of survivors of gynaecologic cancer.