NCT02058550

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Radiation Toxicity
• Vaginal Cancer

Interventions

Type	Name	Description
OTHER	survey administration	Receive reminder email survey
OTHER	computer-assisted intervention	Receive reminder email survey
BEHAVIORAL	telephone-based intervention	Receive reminder phone call

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-01-01
• Completion: 2020-10-23
• First posted: 2014-02-10
• Last updated: 2021-08-17

Locations

1 site across 1 country: United States