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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Endometrial Cancer; Radiation Toxicity; Vaginal Cancer; Cervical Cancer

Treatments: Other: computer-assisted intervention; Behavioral: telephone-based intervention; Other: survey administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02058550

NCI-2013-02400 (Registry Identifier)

GYN0005 (Other Identifier)

IRB-29074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Arm I (no intervention)

No Intervention group

Description:

Patients receive no additional reminders.

Arm II (email survey)

Experimental group

Description:

Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.

Treatment:

Other: computer-assisted intervention

Other: survey administration

Arm III (email surveys and phone calls)

Experimental group

Description:

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.

Treatment:

Other: computer-assisted intervention

Behavioral: telephone-based intervention

Other: survey administration