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

Sponsor

Women's College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01654458

Collaborator

University Health Network, Toronto (Other), Sunnybrook Health Sciences Centre (Other), Tom Baker Cancer Centre (Other), Cross Cancer Institute (Other), Vancouver Coastal Health Research Institute (Other), Memorial Sloan Kettering Cancer Center (Other)

398

Enrollment

Locations

Arms

Duration (Months)

56.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunctions, Psychological Uterine Cervical Neoplasms Ovarian Neoplasms Uterine Neoplasms Genital Neoplasms, Female	Behavioral: GyneGals Support Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

398 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jan 19, 2018

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Immediate Treatment Condition

Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.

Behavioral: GyneGals Support Group

12-week online (i.e. Internet-based), professionally-facilitated support group

No Intervention: Waitlist Control Condition

Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	Tom Baker Cancer Centre	Calgary	Alberta	Canada
3	Cross Cancer Institute	Edmonton	Alberta	Canada
4	Vancouver Coastal Health Research Institute	Vancouver	British Columbia	Canada
5	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
6	University Health Network (Princess Margaret Hospital)	Toronto	Ontario	Canada	M5G 2M9
7	Women's College Hospital	Toronto	Ontario	Canada	M5S 1B2