Study of Vaginal Dilator Use After Pelvic Radiotherapy

June 10, 2015 updated by: Memorial Sloan Kettering Cancer Center

A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering at Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States
        • Memorial Sloan Kettering at Mercy Medical Center
      • Sleepy Hollow, New York, United States
        • Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • The remaining assessments will be performed during the patient's regularly
  • scheduled follow-up appointments or via phone calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure compliance with vaginal dilator use.
Time Frame: conclusion of study
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
conclusion of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Ethel Law, MA, RN, OCN, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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