Clinical trial NCT00789893: Study of Vaginal Dilator Use After Pelvic Radiotherapy
Official title: A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Endometrial Cancer
Rectal Cancer
Anal Cancer
Keywords: external beam pelvic radiation
brachytherapy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 115
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: To measure compliance with vaginal dilator use.
timeFrame: conclusion of study
measure: 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.
timeFrame: conclusion of study
Secondary outcomes:
measure: To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.
timeFrame: conclusion of study
measure: To explore reasons for non-compliance with use of dilators.
timeFrame: conclusion of study
measure: To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ethel Law, MA, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References: