Study of Vaginal Dilator Use After Pelvic Radiotherapy

Overview

Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.

We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.

Full Title of Study: “A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

Interventions

  • Device: Vaginal Dilator
    • Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis & assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st & 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, & the 2nd will be one month ± 2 weeks from last day of radiation.

Arms, Groups and Cohorts

  • Women with cervical, endometrial, rectal or anal cancer
    • Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy

Clinical Trial Outcome Measures

Primary Measures

  • To measure compliance with vaginal dilator use.
    • Time Frame: conclusion of study
  • To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.
    • Time Frame: conclusion of study

Secondary Measures

  • To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
    • Time Frame: conclusion of study
  • To explore reasons for non-compliance with use of dilators.
    • Time Frame: conclusion of study
  • To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.
    • Time Frame: conclusion of study

Participating in This Clinical Trial

Inclusion Criteria

  • Female with cervical, endometrial, rectal or anal cancer
  • Scheduled to begin one of the following treatments at MSKCC:
  • Definitive external beam radiation therapy
  • Preoperative external beam radiation therapy of followed by surgery
  • Postoperative external beam radiation therapy
  • Definitive external beam radiation therapy with intracavitary brachytherapy (tandem and ring or Syed)± surgery
  • Postoperative intravaginal brachytherapy (once every two weeks times three)
  • ≥ or = to 21 years of age

Exclusion Criteria

  • Women with cervical, endometrial, rectal or anal cancer who are/have:
  • Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English.
  • Mental or physical handicaps that would prohibit them from full participation in the study.
  • Prior radiation to the pelvis.
  • Evidence of metastatic disease.

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ethel Law, MA, RN, OCN, Principal Investigator, Memorial Sloan Kettering Cancer Center

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