Clinical trial NCT02058550: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Cancer
Endometrial Cancer
Radiation Toxicity
Vaginal Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-10
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
timeFrame: Up to 25 months after completing radiation
Secondary outcomes:
measure: Vaginal canal length
timeFrame: Up to 25 months after completing radiation
measure: Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03
timeFrame: Up to 30 days after the last dose of study treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Elizabeth Kidd
role: PRINCIPAL_INVESTIGATOR
References: