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Clinical Trial: Vaginal Changes and Sexual Function in Patients With Cervical Cancer
This study is currently recruiting patients.
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 | Treatment or Intervention |
|---|---|
| sexuality and reproductive issues stage IB cervical cancer | Procedure: complications of therapy assessment/management Procedure: supportive care/therapy |
MedlinePlus related topics: Cervical Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Study of Vaginal Length, Elasticity, Lubrication, and Sexual Function in Patients With Stage IB2 Cervical Cancer
Further Study Details:
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: Both
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
Location and Contact Information
Arizona
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62794-9640, United States; Recruiting
L. Stewart Massad, MD 217-545-8882
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Indiana
Saint Joseph Regional Medical Center, South Bend, Indiana, 46617, United States; Recruiting
Michael W. Method, MD, MPH 574-237-8010 mmethod@mhopc.com
Michigan
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
David Gardner Mutch, MD 314-362-3181
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
North Carolina
Gynecologic Oncology Network, Greenville, North Carolina, 27858, United States; Recruiting
Howard David Homesley, MD 252-756-5388 hdh7173@aol.com
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7570, United States; Recruiting
Wesley C. Fowler, MD 919-966-1196 wfowler@med.unc.edu
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Jeffrey McCabe Fowler, MD 614-293-8737
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0520, United States; Recruiting
Nader Husseinzadeh, MD 513-558-8450 nallerhusseinzadeh@uc.edu
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Pennsylvania
Abington Memorial Hospital, Abington, Pennsylvania, 19001-3788, United States; Recruiting
Parviz Hanjani, MD 215-885-0220 phanjani@amh.org
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Nava Siegelmann-Danieli, MD 570-271-6834 nsdanieli@geisinger.edu
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, 15213-3180, United States; Recruiting
Joseph L. Kelley, MD 412-641-5418 jkelley@mail.magee.edu
Tennessee
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, 37917, United States; Recruiting
Kenneth F. Cofer, MD 865-673-9250
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-2516, United States; Recruiting
Marta Ann Crispens, MD 615-322-2114 marta.crispens@vanderbilt.edu
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Anthony Evans, MD, PhD 715-387-5161 evans.anthony@marshfieldclinic.org
Study chairs or principal investigators
Deborah Watkins Bruner, RN, PhD, Study Chair, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000269327; GOG-8003; NCT00053261
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00053261
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00053261
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Administration for Children and Families
- After an Affair: How Marital Therapy Heals the Wounds (American Association for Marriage and Family Therapy)
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