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Vaginal Changes and Sexual Function in Patients With Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053261
First received: January 27, 2003
Last updated: May 9, 2009
Last verified: June 2005
History of Changes
  Purpose

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 Intervention
Cervical Cancer
Sexuality and Reproductive Issues
 Procedure: management of therapy complications

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2003
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053261

Locations
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, New York
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00053261     History of Changes
Other Study ID Numbers: CDR0000269327, GOG-8003
Study First Received: January 27, 2003
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
sexuality and reproductive issues
stage IB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013