Can a simple program help women overcome Post-Radiation pain?
NCT ID NCT07216456
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 4 times
Summary
This study tests a behavioral program to help women who have had pelvic radiation use vaginal dilators more regularly. Dilators can prevent or treat vaginal narrowing that makes exams or sex painful. 88 women will be randomly assigned to either the program (with coping strategies and education) or standard written materials. The study will check if the program is feasible and acceptable, and whether it improves dilator use and reduces symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral program (coping strategies, mindfulness, and education)
- What this could lead to
- If successful, this program could help women stick with dilator therapy, reducing pain and discomfort after pelvic radiation.
- What could go wrong
- This is a small pilot study (88 participants) testing feasibility, not effectiveness. The program may not improve dilator use or symptoms in a larger trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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