A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
NCT ID: NCT01654458
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
398 participants
INTERVENTIONAL
2012-07-31
2019-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Immediate Treatment Condition
Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
GyneGals Support Group
12-week online (i.e. Internet-based), professionally-facilitated support group
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.
No interventions assigned to this group
Interventions
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GyneGals Support Group
12-week online (i.e. Internet-based), professionally-facilitated support group
Eligibility Criteria
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Inclusion Criteria
* 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
* Has a major psychiatric illness
18 Years
FEMALE
No
Sponsors
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University Health Network, Toronto
OTHER
Sunnybrook Health Sciences Centre
OTHER
Tom Baker Cancer Centre
OTHER
Cross Cancer Institute
OTHER
Vancouver Coastal Health Research Institute
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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Catherine C. Classen, PhD
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 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, Canada
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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
Other Identifiers
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1009695
Identifier Type: OTHER
Identifier Source: secondary_id
12-0427-CE
Identifier Type: OTHER
Identifier Source: secondary_id
216-2012
Identifier Type: OTHER
Identifier Source: secondary_id
OVA-120243
Identifier Type: -
Identifier Source: org_study_id
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