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

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ClinicalTrials.gov Identifier: NCT01654458
Recruitment Status : Active, not recruiting
First Posted : July 31, 2012
Last Update Posted : March 28, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Sexual Dysfunctions, Psychological Uterine Cervical Neoplasms Ovarian Neoplasms Uterine Neoplasms Genital Neoplasms, Female Behavioral: GyneGals Support Group

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
Study Start Date : July 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: Immediate Treatment Condition
Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
Behavioral: GyneGals Support Group
12-week online (i.e. Internet-based), professionally-facilitated support group
No Intervention: 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.


Outcome Measures

Primary Outcome Measures :
  1. Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R). [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Sexual function, as measured by the Sexual Function Questionnaire (SFQ). [ Time Frame: 9 months (at months 1, 5, and 9) ]
  2. Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G). [ Time Frame: 9 months (at months 1, 5, and 9) ]
  3. Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 9 months (at months 1, 5, and 9) ]
  4. Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS). [ Time Frame: 9 months (at months 1, 5, and 9) ]
  5. Perceived social support, as measured by MOS Social Support Survey (MOS-SS). [ Time Frame: 9 months (at months 1, 5, and 9) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654458


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, Canada, M5G 2M9
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Tom Baker Cancer Centre
Cross Cancer Institute
Vancouver Coastal Health Research Institute
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Catherine C. Classen, PhD Women's College Hospital
More Information

Publications:
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT01654458     History of Changes
Other Study ID Numbers: OVA-120243
1009695 ( Other Identifier: Women's College Hospital Research Ethics Board )
12-0427-CE ( Other Identifier: University Health Network Research Ethics Board )
216-2012 ( Other Identifier: Research Ethics Board of Sunnybrook Health Sciences Centre )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Women's College Hospital:
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

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Sexual Dysfunctions, Psychological
Genital Neoplasms, Female
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Mental Disorders