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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01654458
Other study ID # OVA-120243
Secondary ID 100969512-0427-C
Status Completed
Phase N/A
First received
Last updated
Start date July 2012
Est. completion date September 2019

Study information

Verified date March 2021
Source Women's College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date September 2019
Est. primary completion date January 19, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
GyneGals Support Group
12-week online (i.e. Internet-based), professionally-facilitated support group

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network (Princess Margaret Hospital) Toronto Ontario
Canada Women's College Hospital Toronto Ontario
Canada Vancouver Coastal Health Research Institute Vancouver British Columbia
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (7)

Lead Sponsor Collaborator
Women's College Hospital Cross Cancer Institute, Memorial Sloan Kettering Cancer Center, Sunnybrook Health Sciences Centre, Tom Baker Cancer Centre, University Health Network, Toronto, Vancouver Coastal Health Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

References & 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. — View Citation

Classen 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

Wiljer 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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