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

March 15, 2021 updated by: Women's College Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
Time Frame: 9 months
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).
Time Frame: 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.
9 months (at months 1, 5, and 9)
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
Time Frame: 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.
9 months (at months 1, 5, and 9)
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
Time Frame: 9 months (at months 1, 5, and 9)
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).
Time Frame: 9 months (at months 1, 5, and 9)
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).
Time Frame: 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.
9 months (at months 1, 5, and 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

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

Investigators

  • Principal Investigator: Catherine C. Classen, PhD, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 19, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVA-120243
  • 1009695 (Other Identifier: Women's College Hospital Research Ethics Board)
  • 12-0427-CE (Other Identifier: University Health Network Research Ethics Board)
  • 216-2012 (Other Identifier: Research Ethics Board of Sunnybrook Health Sciences Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Cervical Neoplasms

Clinical Trials on GyneGals Support Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe