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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02058550
First received: February 6, 2014
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Endometrial Cancer
Radiation Toxicity
Vaginal Cancer
Other: survey administration
Other: computer-assisted intervention
Behavioral: telephone-based intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation [ Time Frame: Up to 25 months after completing radiation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Vaginal canal length [ Time Frame: Up to 25 months after completing radiation ] [ Designated as safety issue: No ]
    The vaginal canal length will be measured using an extra small dilator and it will be calculated in centimeters. The vaginal canal length measurements will be analyzed in a repeated measures model with treatment as a fixed effect and time as a within subject effect. 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.

  • Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 30 days after the last dose of study treatment ] [ Designated as safety issue: Yes ]
    The adverse events will be tabulated by type and grade at each follow up. The total number of AE's as well as the number of AE's in each category: gynecologic, urinary and gastrointestinal will tabulated. The test of proportion will be done per category of AE. Since it is possible that the rates will be low, an exact test will be used to compare the rates.


Estimated Enrollment: 72
Study Start Date: September 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm I (no intervention)
Patients receive no additional reminders.
Experimental: Arm II (email survey)
Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.
Other: survey administration
Receive reminder email survey
Other: computer-assisted intervention
Receive reminder email survey
Experimental: Arm III (email surveys and phone calls)
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
Receive reminder email survey
Other: computer-assisted intervention
Receive reminder email survey
Behavioral: telephone-based intervention
Receive reminder phone call

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058550

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Alice Banh    650-723-1423    aliceb@stanford.edu   
Principal Investigator: Elizabeth A. Kidd         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Elizabeth Kidd Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02058550     History of Changes
Other Study ID Numbers: GYN0005, NCI-2013-02400, 29074, P30CA124435
Study First Received: February 6, 2014
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vaginal Neoplasms
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Vaginal Diseases

ClinicalTrials.gov processed this record on November 20, 2014