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Vaginal Dilator Therapy After Pelvic Radiation

RecruitingNAAges 18 Years - anyFemaleDuke University
NCT07216456 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. * T

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📋 Eligibility rules (as published)
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
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What it tests

  • Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
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Where

1 site
Duke University Medical Center
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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