Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
Conditions
Cervical Cancer - Endometrial Cancer - Radiation Toxicity - Vaginal Cancer
Conditions: official terms
Uterine Cervical Neoplasms - Vaginal Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: survey administration Type: Other
Name: computer-assisted intervention Type: Other
Name: telephone-based intervention Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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 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

Exclusion Criteria:

- 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)
Location
Stanford University Hospitals and Clinics
Stanford, California, United States
Status: Recruiting
Contact: Polly Young - 650-497-7499 - polly.young@stanford.edu
Start Date
September 2014
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page