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

Ovarian Neoplasms Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

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

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)