Quality of Life in Survivors of Gynecologic Cancer

NCT ID: NCT00003795

Last Updated: 2013-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-04-30

Brief Summary

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RATIONALE: Quality-of-life assessment in cancer survivors may help determine the long-term effects of having had gynecologic cancer and may help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying the quality of life in survivors of gynecologic cancer.

Detailed Description

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OBJECTIVES:

* Describe the significant quality of life (QOL) concerns and long term survivorship issues of women diagnosed and treated for early stage ovarian and endometrial cancer five or more years ago.
* Identify mechanisms which contribute to a gynecologic cancer survivorship model through comparison and prediction of high versus low QOL associated with long term adjustment and survivorship. Examine social support, coping efforts, self-efficacy, meaning associated with survivorship, performance status, and age at diagnosis as potential predictors.
* Identify and compare factors that predict high versus low QOL for women with early stage endometrial cancer completing participation in GOG-99 clinical trial. Conduct exploratory analysis examining long term QOL concerns of survivors randomized to surgery arm with or without radiotherapy.

OUTLINE: Patients complete one telephone interview with a professional female interviewer. The interview lasts approximately 60 minutes and is audiotaped.

PROJECTED ACCRUAL: A total of 197 early stage endometrial cancer survivors and 114 early stage ovarian cancer survivors will be accrued for this study within 2 years.

Conditions

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Endometrial Cancer Ovarian Cancer

Interventions

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quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Must be capable of completing telephone interview in English

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Principal Investigators

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Lari B. Wenzel, PhD

Role: STUDY_CHAIR

Chao Family Comprehensive Cancer Center

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Community Hospital of Los Gatos

Los Gatos, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, United States

Site Status

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Site Status

New England Medical Center Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Cooper Hospital/University Medical Center

Camden, New Jersey, United States

Site Status

Cancer Center of Albany Medical Center

Albany, New York, United States

Site Status

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, United States

Site Status

Schneider Children's Hospital at North Shore

Manhasset, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, United States

Site Status

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Site Status

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Brookview Research, Inc.

Nashville, Tennessee, United States

Site Status

Simmons Cancer Center - Dallas

Dallas, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Tacoma General Hospital

Tacoma, Washington, United States

Site Status

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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GOG-9902

Identifier Type: -

Identifier Source: secondary_id

CDR0000066938

Identifier Type: -

Identifier Source: org_study_id

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