CompletedPhase 1

Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

United States72 participantsStarted 2014-09

Plain-language summary

This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment * Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment. * Patients should have a life expectancy of at least 1 year * No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements * No organ and marrow function requirements * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded * No restrictions regarding use of other investigational agents * No exclusion requirements due to co-morbid disease or intercurrent illness * No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device * No exclusion criteria relating to concomitant medications * No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)

What they're measuring

Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation

Timeframe: Up to 25 months after completing radiation

Trial details

NCT IDNCT02058550

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01