Study of Vaginal Dilator Use After Pelvic Radiotherapy
A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
1 other identifier
observational
115
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2008
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 11, 2015
June 1, 2015
6.6 years
November 12, 2008
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To measure compliance with vaginal dilator use.
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.
conclusion of study
Secondary Outcomes (3)
To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
conclusion of study
To explore reasons for non-compliance with use of dilators.
conclusion of study
To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.
conclusion of study
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
All women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ethel Law, MA, RN, OCN
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 11, 2015
Record last verified: 2015-06