Spots Global Cancer Trial Database for Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

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Trial Identification

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

Official Title: Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy

Study ID: NCT02058550

Conditions

Interventions

survey administration

computer-assisted intervention

telephone-based intervention

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey. SECONDARY OBJECTIVES: I. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive no additional reminders. ARM II: Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation. ARM III: Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up. After completion of study, patients are followed up at 10-14 weeks, 5-7 months, 8-10 months, 11-13 months, 15-17 months, 19-21 months, and 23-25 months post treatment.