Vaginal Changes and Sexual Function in Patients With Cervical Cancer
- Conditions
- Cervical CancerSexuality and Reproductive Issues
- Registration Number
- NCT00053261
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
* Compare these differences between the patients in the two treatment groups in GOG-0201.
* Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
* Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
* Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Borgess Medical Center
🇺🇸Kalamazooaa, Michigan, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States