NCT00053261

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 27, 2013

Status Verified

June 1, 2005

Enrollment Period

3.5 years

First QC Date

January 27, 2003

Last Update Submit

May 24, 2013

Conditions

Cervical CancerSexuality and Reproductive Issues

Keywords

sexuality and reproductive issuesstage IB cervical cancer

Interventions

management of therapy complicationsPROCEDURE

Eligibility Criteria

AgeUp to 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsSexuality

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual BehaviorBehavior

Study Officials

  • Deborah Watkins Bruner, RN, PhD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

July 1, 2003

Primary Completion

January 1, 2007

Last Updated

May 27, 2013

Record last verified: 2005-06

Locations

US(12)