Vaginal Changes and Sexual Function in Patients With Cervical Cancer

Gynecologic Oncology Group (GOG)

Status: Completed

Conditions: Sexuality and Reproductive Issues; Cervical Cancer

Treatments: Procedure: management of therapy complications

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00053261

GOG-8003

CDR0000269327

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: Under 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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