Cervical Cancer Clinical Trial
Official title:
Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
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.
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.
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