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

Not Applicable

Completed

• Conditions: Sexual Dysfunctions, Psychological; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Neoplasms; Ovarian Neoplasms
• Interventions: Behavioral: GyneGals Support Group

• Registration Number: NCT01654458
• Lead Sponsor: Women's College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Primary Completion: 2018-01-19
• Study Completion: 2019-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

Inclusion Criteria

• Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
• Not receiving active treatment
• Currently disease-free for a minimum of 3 months
• No more than 5 years post-diagnosis
• Distressed due to psychosexual concerns related to cancer
• Willing to discuss psychosexual concerns
• 18 years or older
• Has access to a computer and the Internet
• Speaks, reads, and writes in English
• Provides informed consent

Exclusion Criteria

• Acutely suicidal (i.e., actively suicidal within the previous 3 months)
• Has a major psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Treatment Condition	GyneGals Support Group	Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.

Primary Outcome Measures

Name	Time	Method
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).	9 months	13-item self-report scale that measures sexually-related distress in women.

Secondary Outcome Measures

Name	Time	Method
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).	9 months (at months 1, 5, and 9)	Consists of two independent scales designed to assess changes in sexuality and body image before and after diagnosis.
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).	9 months (at months 1, 5, and 9)	14-item self-report questionnaire for detecting depression and anxiety in a hospital outpatient setting.
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).	9 months (at months 1, 5, and 9)	7-item measure assessing satisfaction with an individual's romantic relationship.
Perceived social support, as measured by MOS Social Support Survey (MOS-SS).	9 months (at months 1, 5, and 9)	19 items and assesses emotional/informational support, tangible support, affectionate support, and positive social interaction, as well as providing an overall functional support index.
Sexual function, as measured by the Sexual Function Questionnaire (SFQ).	9 months (at months 1, 5, and 9)	25-item measure developed for cancer patients and can be completed by women regardless of sexual orientation or whether they have a partner.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University Health Network (Princess Margaret Hospital); 🇨🇦 Toronto, Ontario, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Vancouver Coastal Health Research Institute; 🇨🇦 Vancouver, British Columbia, Canada