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

Primary Purpose

Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
GyneGals Support Group
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sexual Dysfunctions, Psychological focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Vancouver Coastal Health Research Institute
  • Sunnybrook Health Sciences Centre
  • University Health Network (Princess Margaret Hospital)
  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Treatment Condition

Waitlist Control Condition

Arm Description

Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.

Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
7-item measure assessing satisfaction with an individual's romantic relationship.
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.

Full Information

First Posted
July 27, 2012
Last Updated
March 15, 2021
Sponsor
Women's College Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01654458
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment Condition
Arm Type
Experimental
Arm Description
Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
Arm Title
Waitlist Control Condition
Arm Type
No Intervention
Arm Description
Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.
Intervention Type
Behavioral
Intervention Name(s)
GyneGals Support Group
Intervention Description
12-week online (i.e. Internet-based), professionally-facilitated support group
Primary Outcome Measure Information:
Title
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
Description
13-item self-report scale that measures sexually-related distress in women.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
Description
25-item measure developed for cancer patients and can be completed by women regardless of sexual orientation or whether they have a partner.
Time Frame
9 months (at months 1, 5, and 9)
Title
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
Description
Consists of two independent scales designed to assess changes in sexuality and body image before and after diagnosis.
Time Frame
9 months (at months 1, 5, and 9)
Title
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
Description
14-item self-report questionnaire for detecting depression and anxiety in a hospital outpatient setting.
Time Frame
9 months (at months 1, 5, and 9)
Title
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
Description
7-item measure assessing satisfaction with an individual's romantic relationship.
Time Frame
9 months (at months 1, 5, and 9)
Title
Perceived social support, as measured by MOS Social Support Survey (MOS-SS).
Description
19 items and assesses emotional/informational support, tangible support, affectionate support, and positive social interaction, as well as providing an overall functional support index.
Time Frame
9 months (at months 1, 5, and 9)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine C. Classen, PhD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network (Princess Margaret Hospital)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22374732
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.
Results Reference
background
PubMed Identifier
21594587
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.
Results Reference
background
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
Results Reference
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A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer

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