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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female

Intervention / Treatment
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* Behavioral: GyneGals Support Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Condition<br>Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment. | Behavioral: GyneGals Support Group<br>* 12-week online (i.e. Internet-based), professionally-facilitated support group<br>|
| No Intervention: Waitlist Control Condition<br>Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunctions, Psychological, Psychotherapy, Group, Genital Neoplasms, Female, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms