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

NCT01654458CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Women's College Hospital

Enrollment

398

Start Date

2012-07-01

Completion Date

2018-01-19

Study Type

INTERVENTIONAL

Official Title

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

Interventions

GyneGals Support Group

Conditions

Sexual DysfunctionsPsychologicalUterine Cervical NeoplasmsOvarian NeoplasmsUterine NeoplasmsGenital NeoplasmsFemale

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

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.

Time frame: 9 months (at months 1, 5, and 9)

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.

Time frame: 9 months (at months 1, 5, and 9)

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.

Time frame: 9 months (at months 1, 5, and 9)

Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).

7-item measure assessing satisfaction with an individual's romantic relationship.

Time frame: 9 months (at months 1, 5, and 9)

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.

Time frame: 9 months (at months 1, 5, and 9)

Locations

Memorial Sloan Kettering Cancer Center, New York, United States

Tom Baker Cancer Centre, Calgary, Canada

Cross Cancer Institute, Edmonton, Canada

Vancouver Coastal Health Research Institute, Vancouver, Canada

Sunnybrook Health Sciences Centre, Toronto, Canada

University Health Network (Princess Margaret Hospital), Toronto, Canada

Women's College Hospital, Toronto, Canada

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