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

Official Title

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

Summary:

There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment. The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.

Trial Description

Primary Outcome:

  • Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
Secondary Outcome:
  • Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
  • Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
  • Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
  • Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
  • Perceived social support, as measured by MOS Social Support Survey (MOS-SS).

280 women will be recruited from across Ontario over five years. An additional 240 women will be recruited at recruitment sites in British Columbia, Alberta, and New York. However, this recruitment will only begin in the second year of the study.

Once a cohort of 40 women has been recruited within a site, they will be randomized into two groups of 20 participants to receive either immediate treatment or the control condition. The control group will also have an opportunity to receive the intervention; however, this group will receive the treatment only after its involvement in the study has ended, as a courtesy. Participants will be assessed at baseline, 5-month (post-treatment) and 9-month follow-ups. This provides a comparison at the 5-month assessment for treatment versus control condition. The 9-month assessment enables us to assess whether the benefits of the intervention are maintained over time in the treatment condition.

The intervention consists of a 12-week, asynchronous online group (i.e., bulletin board format) with one scheduled synchronous session (i.e., chat session) in Week 10 and includes access to psychoeducational material related to sexuality and gynecologic cancer. A 90-minute chat session, offered in week 10, allows participants to ask questions in real time of experts in gynecologic cancer and sexuality.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society