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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
Secondary Outcome
Vaginal canal length
Condition
Cervical Cancer
Intervention
survey administration
Study Arms / Comparison Groups
Arm I (no intervention)
Description: Patients receive no additional reminders.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
72
Start Date
September 2014
Completion Date
October 23, 2020
Primary Completion Date
January 2019
Eligibility 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 may be enrolled while undergoing vaginal brachytherapy radiation treatment. - 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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Elizabeth Kidd, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02058550
Organization ID
IRB-29074
Secondary IDs
NCI-2013-02400
Responsible Party
Sponsor
Study Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Elizabeth Kidd, Principal Investigator, Stanford University Hospitals and Clinics
Verification Date
August 2021