Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Natural history/Epidemiology | Completed | Under 70 | NCI | GOG-8003 NCT00053261 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age
- Under 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Expected Enrollment
Approximately 150 patients will be accrued for this study.
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.
Trial Lead Organizations
Gynecologic Oncology Group
 | | | |
| Deborah Watkins Bruner, RN, PhD, Protocol chair | |
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Related Information
| Registry Information | ||
| ||
| Official Title | Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma | |
| ||
| Trial Start Date | 2003-07-21 | |
| ||
| Trial Completion Date | 2007-01-14 | |
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| Registered in ClinicalTrials.gov | NCT00053261 | |
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| Date Submitted to PDQ | 2002-11-20 | |
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| Information Last Verified | 2005-06-07 | |
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| NCI Grant/Contract Number | CA27469 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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