Genital Neoplasms, Female, Ovarian Neoplasms, Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Uterine Neoplasms
Conditions
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
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.
Interventions
BEHAVIORALGyneGals Support Group
12-week online (i.e. Internet-based), professionally-facilitated support group
Sponsors
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
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R). | 9 months | 13-item self-report scale that measures sexually-related distress in women. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function, as measured by the Sexual Function Questionnaire (SFQ). | 9 months (at months 1, 5, and 9) | 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). | 9 months (at months 1, 5, and 9) | 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). | 9 months (at months 1, 5, and 9) | 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). | 9 months (at months 1, 5, and 9) | 7-item measure assessing satisfaction with an individual's romantic relationship. |
| Perceived social support, as measured by MOS Social Support Survey (MOS-SS). | 9 months (at months 1, 5, and 9) | 19 items and assesses emotional/informational support, tangible support, affectionate support, and positive social interaction, as well as providing an overall functional support index. |
Countries
Canada, United States
Outcome results
None listed