Vaginal Changes and Sexual Function in Patients With Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma

Conditions
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Cervical Cancer, Sexuality and Reproductive Issues

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexuality and reproductive issues, stage IB cervical cancer