Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
Completed · Phase 1
Conditions studied: Cervical Cancer, Endometrial Cancer, Radiation Toxicity, Vaginal Cancer
In brief
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.
Key facts
- Study ID
- NCT02058550
- Run by
- Stanford University
- People needed
- 72
- Starts
- 2014-09-01
- Expected to finish
- 2020-10-23
- Last updated by the study team
- 2021-08-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Stanford University, School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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