A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
4 other identifiers
interventional
398
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 27, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 18, 2021
March 1, 2021
5.6 years
July 27, 2012
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
9 months (at months 1, 5, and 9)
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
9 months (at months 1, 5, and 9)
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
9 months (at months 1, 5, and 9)
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
9 months (at months 1, 5, and 9)
Perceived social support, as measured by MOS Social Support Survey (MOS-SS).
9 months (at months 1, 5, and 9)
Study Arms (2)
Immediate Treatment Condition
EXPERIMENTALReceives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
Waitlist Control Condition
NO INTERVENTIONWaitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.
Interventions
12-week online (i.e. Internet-based), professionally-facilitated support group
Eligibility Criteria
You may qualify if:
- 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
- years or older
- Has access to a computer and the Internet
- Speaks, reads, and writes in English
- Provides informed consent
You may not qualify if:
- Acutely suicidal (i.e., actively suicidal within the previous 3 months)
- Has a major psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women's College Hospitallead
- University Health Network, Torontocollaborator
- Sunnybrook Health Sciences Centrecollaborator
- Tom Baker Cancer Centrecollaborator
- Cross Cancer Institutecollaborator
- Vancouver Coastal Health Research Institutecollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
Study Sites (7)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, M5G 2M9, Canada
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Related Publications (3)
Classen CC, Chivers ML, Urowitz S, Barbera L, Wiljer D, O'Rinn S, Ferguson SE. Psychosexual distress in women with gynecologic cancer: a feasibility study of an online support group. Psychooncology. 2013 Apr;22(4):930-5. doi: 10.1002/pon.3058. Epub 2012 Feb 28.
PMID: 22374732BACKGROUNDWiljer D, Urowitz S, Barbera L, Chivers ML, Quartey NK, Ferguson SE, To M, Classen CC. A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. J Cancer Educ. 2011 Sep;26(3):451-8. doi: 10.1007/s13187-011-0215-1.
PMID: 21594587BACKGROUNDClassen CC, Drozd A, Brotto LA, Barbera L, Carter J, Chivers ML, Koval J, Robinson JW, Urowtiz S, Wiljer D, & Ferguson SE. Protocol of a randomized controlled trial of an online support group for sexual distress due to gynecologic caner. Journal of Clinical Trials 5(4), 2015. DOI: 10.4172/2167-0870.1000234
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine C. Classen, PhD
Women's College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2012
First Posted
July 31, 2012
Study Start
July 1, 2012
Primary Completion
January 19, 2018
Study Completion
September 1, 2019
Last Updated
March 18, 2021
Record last verified: 2021-03