Back to resultsVaginal Changes and Sexual Function in Patients With Cervical Cancer
Primary Purpose
Cervical Cancer, Sexuality and Reproductive Issues
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
management of therapy complications
Sponsored by
About this trial
This is an observational trial for Cervical Cancer focused on measuring sexuality and reproductive issues, stage IB cervical cancer
Eligibility 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
Sites / Locations
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Long Island Cancer Center at Stony Brook University Hospital
- SUNY Upstate Medical University Hospital
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Oklahoma University Medical Center
- Cancer Care Associates - Midtown Tulsa
- Abington Memorial Hospital
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00053261
First Posted
January 27, 2003
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00053261
Brief Title
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
Official Title
Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
Study Type
Observational
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Sexuality and Reproductive Issues
Keywords
sexuality and reproductive issues, stage IB cervical cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Watkins Bruner, RN, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazooaa
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Midtown Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
12. IPD Sharing Statement
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Vaginal Changes and Sexual Function in Patients With Cervical Cancer
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