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

NCT02058550 | Completed Phase 1

• 3 other identifiers: IRB-29074NCI-2013-02400GYN0005
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Endometrial Cancer; Radiation Toxicity; Vaginal Cancer

Outcome Measures

Primary Outcomes (1)

• Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation

  The vaginal dilator adherence measurements will analyzed in repeated measures model with treatment as a fixed effect and time as a within subject effect. The overall mean of vaginal dilator adherence among the 3 groups will also be measured and compared. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.

  Up to 25 months after completing radiation

Secondary Outcomes (2)

• Vaginal canal length

  Up to 25 months after completing radiation

• Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03

  Up to 30 days after the last dose of study treatment

Study Arms (3)

Arm I (no intervention)

NO INTERVENTION

Patients receive no additional reminders.

Arm II (email survey)

EXPERIMENTAL

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

Other: survey administration; Other: computer-assisted intervention

Arm III (email surveys and phone calls)

EXPERIMENTAL

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.

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

Interventions

survey administration OTHER

Receive reminder email survey

Arm II (email survey); Arm III (email surveys and phone calls)

computer-assisted intervention OTHER

Receive reminder email survey

Arm II (email survey); Arm III (email surveys and phone calls)

telephone-based intervention BEHAVIORAL

Receive reminder phone call

Arm III (email surveys and phone calls)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
• No restrictions regarding use of other investigational agents

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Radiation Injuries; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries; Vaginal Diseases

Study Officials

• Elizabeth Kidd

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: October 23, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)