Clinical trial · Interventional
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sexual Dysfunctions, Psychological | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GyneGals Support Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate Treatment Condition
- description
- Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
- interventionNames
- Behavioral: GyneGals Support Group
- type
- NO_INTERVENTION
- label
- Waitlist Control Condition
- description
- Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.
Primary outcomes (1)
- measure
- Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
- timeFrame
- 9 months
- description
- 13-item self-report scale that measures sexually-related distress in women.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDClassen 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. PMID 22374732
- BACKGROUNDWiljer 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. PMID 21594587
- BACKGROUNDClassen 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