Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cervical Cancer
  • Endometrial Cancer
  • Radiation Toxicity
  • Vaginal Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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. Evalua...

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.

Tracking Information

NCT #
NCT02058550
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth Kidd Stanford University Hospitals and Clinics