Vaginal Dilator Therapy After Pelvic Radiation
This study is testing a new program called "Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation" to help women use vaginal dilators more consistently after pelvic radiation therapy. Pelvic radiation can sometimes cause vaginal narrowing (vaginal stenosis), which dilators help prevent or treat. The program uses coping strategies like relaxation and mindfulness, along with education on how to use dilators. You might be able to join if you are an adult woman (18 or older) who has completed pelvic radiation for certain cancers in the past year, has been recommended dilator therapy, and can speak English. The study will look at how easy the program is to complete and how acceptable it is to participants over 3 months. The current status of the study is unclear.
- Study design
- This study is an interventional study with a planned enrollment of 130 participants. It will involve developing and refining the program through interviews before testing it with a larger group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after starting the program to assess feasibility and acceptability.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vaginal Dilator Therapy After Pelvic Radiation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Juliann Stalls, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility, as Measured by Session Completion and Attrition3 months post-baseline
Feasibility will be determined by 1) greater than or equal to 80% of sessions completed and 2) attrition rate of less than or equal to 20%.
- Acceptability, as Measured by the Treatment Acceptability Questionnaire3 months post-baseline
Acceptability will be determined by average score of 5 or greater on the Treatment Acceptability Questionnaire (TAQ). The TAQ is a six-item measure assessing perceptions of an interventions acceptability, ethics, and effectiveness. Items are rated on a 7-point Likert scale, from "very unacceptable" to "very acceptable".