Clinical trial · Interventional
Vaginal Dilator Therapy After Pelvic Radiation
Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
- 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)
This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed. In Phase I of the study, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform the behavioral program development. In Phase II, the program will be refined through user testing interviews (N=12). In Phase III, 88 participants will be randomly assigned to one of two groups: * One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use. * The other group will receive written educational materials (enhanced usual care). The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins. The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorectal Cancer | Malignant Anorectal Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
| Pelvic Radiotherapy | — | UNRESOLVED | — |
| Urologic Cancer | — | UNRESOLVED | — |
| Vaginal Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
- description
- A 6-session (45 minutes each) behavioral intervention will be delivered individually and remotely via videoconferencing. The intervention will be designed to improve engagement with vaginal dilator therapy among female cancer survivors who underwent pelvic radiation therapy. The intervention includes coping strategies from cognitive behavioral therapy (e.g., progressive muscle relaxation) and acceptance and commitment therapy (e.g., mindfulness), as well as psychoeducation (e.g., how to use dilators), to enhance engagement with vaginal dilator therapy.
- interventionNames
- Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
- type
- NO_INTERVENTION
- label
- Enhanced Usual Care
- description
- Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration).
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female sex * adults aged 18 years or older * diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and/or bladder * completed pelvic radiation therapy in the past year * dilator therapy recommended by medical provider and standardized dilator received from provider * able to speak/read English Exclusion Criteria: * aged less than 17 years * under the care of a pelvic floor physical therapist at the time of study enrollment * have a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider * inability to provide consent
References
Publications (0)
Data not yet available