Study of Vaginal Dilator Use After Pelvic Radiotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Conditions
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Cervical Cancer, Endometrial Cancer, Rectal Cancer, Anal Cancer

Intervention / Treatment
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* Device: Vaginal Dilator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with cervical, endometrial, rectal or anal cancer<br>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<br>* 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.<br>* Other names: scheduled follow-up appointments or via phone calls.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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external beam pelvic radiation, brachytherapy