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

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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

September 2022

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

April 2020