Study of Vaginal Dilator Use After Pelvic Radiotherapy - Full Text View

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:

MedlinePlus related topics: Anal Cancer Benign Tumors Cancer Cervical Cancer

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	November 2013 (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.

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

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:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

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:	October 29, 2012
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
Adenoma
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 13, 2013