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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053261 |
Purpose
RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.
PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Sexuality and Reproductive Issues |
Procedure: management of therapy complications |
| Study Type: | Observational |
| Official Title: | Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma |
| Study Start Date: | July 2003 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| United States, New York | |
| Long Island Cancer Center at Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11794 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| Cancer Care Associates - Midtown Tulsa | |
| Tulsa, Oklahoma, United States, 74104 | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18105 | |
| Study Chair: | Deborah Watkins Bruner, RN, PhD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000269327, GOG-8003 |
| Study First Received: | January 27, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053261 History of Changes |
| Health Authority: | United States: Federal Government |
|
sexuality and reproductive issues stage IB cervical cancer |
|
Carcinoma |
