Clinical trial NCT01654458: A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
Official title: A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunctions, Psychological
Uterine Cervical Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Keywords: Sexual Dysfunctions, Psychological
Psychotherapy, Group
Genital Neoplasms, Female
Endometrial Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Urogenital Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Sunnybrook Health Sciences Centre
name: Tom Baker Cancer Centre
name: Cross Cancer Institute
name: Vancouver Coastal Health Research Institute
name: Memorial Sloan Kettering Cancer Center
First posted: 2012-07-31
Enrollment: 398
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
timeFrame: 9 months
Secondary outcomes:
measure: Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
timeFrame: 9 months (at months 1, 5, and 9)
measure: Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
timeFrame: 9 months (at months 1, 5, and 9)
measure: Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
timeFrame: 9 months (at months 1, 5, and 9)
measure: Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
timeFrame: 9 months (at months 1, 5, and 9)
measure: Perceived social support, as measured by MOS Social Support Survey (MOS-SS).
timeFrame: 9 months (at months 1, 5, and 9)
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (Princess Margaret Hospital)
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Catherine C. Classen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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