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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| Tom Baker Cancer Centre | OTHER |
| Cross Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment Condition | Experimental | Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment. |
|
| Waitlist Control Condition | No Intervention | Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GyneGals Support Group | Behavioral | 12-week online (i.e. Internet-based), professionally-facilitated support group |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months (at months 1, 5, and 9) |
| Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine C. Classen, PhD | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| Tom Baker Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22374732 | Background | 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. | |
| 21594587 | Background | 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. |
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| OTHER |
| Vancouver Coastal Health Research Institute | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
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Consists of two independent scales designed to assess changes in sexuality and body image before and after diagnosis. |
| 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. | 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. | 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. | 9 months (at months 1, 5, and 9) |
| Calgary |
| Alberta |
| Canada |
| Cross Cancer Institute | Edmonton | Alberta | Canada |
| Vancouver Coastal Health Research Institute | Vancouver | British Columbia | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network (Princess Margaret Hospital) | Toronto | Ontario | M5G 2M9 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Background | 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 |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D014565 | Urogenital Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D052801 | Male Urogenital Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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