Vaginal Changes and Sexual Function in Patients With Cervical Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201
-
May have refused entry on GOG-0201 as long as treatment is prescribed according to one or the other arm
PATIENT CHARACTERISTICS:
Age
- Under 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31403 |
| 2 | Borgess Medical Center | Kalamazooaa | Michigan | United States | 49001 |
| 3 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 4 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 5 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 6 | Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York | United States | 11794 |
| 7 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 8 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 9 | Oklahoma University Medical Center | Oklahoma City | Oklahoma | United States | 73104 |
| 10 | Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | United States | 74104 |
| 11 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 12 | John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18105 |
Sponsors and Collaborators
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Deborah Watkins Bruner, RN, PhD, Fox Chase Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000269327
- GOG-8003