Clinical trial · Interventional
Improving Sexual Health in Gynecologic Cancer Patients
NCT03827993CI-TRIAL-00059350terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dedicated sexual health clinic appointment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Routine surveillance
- description
- Routine surveillance consists of attending gynecologic oncology office visits and being provided with an educational pamphlet discussing common sexual health concerns in gynecologic cancer patients, describing vaginal dilators, moisturizers, and lubrication. Resources for psychosocial counseling, physical therapy, and the sexual health clinic will be provided as well. Participants will have follow up at baseline, 3, 6, 9, and 12 months. Baseline visit consists of the initial visit where the Female Sexual Function Index (FSFI) screen was performed. Subsequent follow up visits will consist of FSFI, Female Sexual Distress Scale (FSDS), Kessler 10 surveys, and clinical assessment with Vaginal Assessment Scale and Vulvar Assessment Scale (VAS and VuAS).
- type
- EXPERIMENTAL
- label
- Dedicated sexual health clinic appointment
- description
- Dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This will consist of the provider performing a focused history and physical, who will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required. The participants will follow up at 3, 6, 9, and 12 months after initial visit, either with the sexual health focused provider or their primary gynecologic oncologist, as determined by the needs of the participant per the provider.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to consent * Screening positive for sexual health dysfunction as per baseline FSFI * Diagnosed with any gynecologic malignancy It is acceptable to have received treatment prior to or during enrollment, including prior surgery, chemotherapy, radiation, hormonal therapy, or clinical trial. Exclusion Criteria: * Unable to speak English * Patients unable to consent
References
Publications (0)
Data not yet available
No reference posted for this study.