Quality of Life in Survivors of Gynecologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003795
First received: November 1, 1999
Last updated: May 24, 2013
Last verified: March 2009
  Purpose

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.


Condition Intervention
Endometrial Cancer
Ovarian Cancer
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Quality of Life of Gynecologic Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 311
Study Start Date: April 1999
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed early stage ovarian and endometrial cancer survivors treated and diagnosed five or more years ago
  • Patients completing treatment in GOG-95 or GOG-99 protocols at least 5 years ago with no recurrence of disease
  • Patients with secondary malignancy or under treatment for other medical conditions are eligible

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003795

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Schneider Children's Hospital at North Shore
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003795     History of Changes
Other Study ID Numbers: CDR0000066938, GOG-9902
Study First Received: November 1, 1999
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage I endometrial carcinoma
stage II endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 23, 2014