Quality of Life in Survivors of Gynecologic Cancer
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003795
First received: November 1, 1999
Last updated: May 15, 2009
Last verified: March 2009
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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 National Cancer Institute (NCI):
| Estimated Enrollment: | 311 |
| Study Start Date: | April 1999 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003795
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Hide Study LocationsLocations
| 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 15, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 Adenoma 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 22, 2013