Prospective randomized trial of email and/or telephone reminders to enhance vaginal dilator compliance in patients undergoing brachytherapy for gynecologic malignancies.

PURPOSE: To evaluate whether email survey +/- telephone reminder versus no intervention would facilitate compliance with vaginal dilator use in women undergoing brachytherapy for gynecologic malignancies and to assess changes in vaginal canal (VC) length between the groups. METHODS AND MATERIALS: A 72 patients were enrolled onto a three-arm single-institution randomized prospective clinical trial and stratified by whether they received external beam radiation treatment in addition to brachytherapy and by total radiation dose to the VC. Patients were subsequently randomized to one of three groups: email survey alone, email survey + telephone reminder, or no intervention. Change in VC length over time was measured for each patient.
RESULTS: The median follow-up time was 17.3 months. There were no differences in patient-reported compliance between the 3 groups. Vaginal dilator compliance fell over the course of the study period and was 33% at 24 months. Baseline VC length and radiation dose were found to be the most important predictors of VC shortening over time. When accounting for baseline length, radiation dose, and follow-up time, type of intervention did not impact changes in VC length from baseline (p = 0.20).
CONCLUSIONS: Our study is the first to show the importance of baseline VC length as it relates to VC shortening following brachytherapy for gynecologic cancers and highlights the difficulties in improving VC compliance among this patient population. Further study is required to improve the incidence of late effects in this group.

RCT Entities:   Population Interventions Outcomes