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, 2014
Last verified: September 2014

November 12, 2008
September 23, 2014
November 2008
November 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00789893 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Vaginal Dilator Use After Pelvic Radiotherapy
A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy.

  • Cervical Cancer
  • Endometrial Cancer
  • Rectal Cancer
  • Anal Cancer
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.
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
Intervention: Device: Vaginal Dilator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Female
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789893
08-127
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Ethel Law, MA, RN, OCN Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP