Study of Vaginal Dilator Use After Pelvic Radiotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00789893
First received: November 12, 2008
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Cervical Cancer
Endometrial Cancer
Rectal Cancer
Anal Cancer
Device: Vaginal Dilator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To measure compliance with vaginal dilator use. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To explore reasons for non-compliance with use of dilators. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: November 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  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: NCT00789893

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Ethel Law, MA, RN, OCN Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00789893     History of Changes
Other Study ID Numbers: 08-127
Study First Received: November 12, 2008
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
external beam pelvic radiation
brachytherapy

Additional relevant MeSH terms:
Anus Neoplasms
Endometrial Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases

ClinicalTrials.gov processed this record on July 28, 2014