Quality of Life in Survivors of Gynecologic Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003795

Collaborator

National Cancer Institute (NCI) (NIH)

311

Enrollment

Locations

7.1

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Endometrial Cancer Ovarian Cancer	Procedure: quality-of-life assessment

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

311 participants

Official Title:

Quality of Life of Gynecologic Cancer Survivors

Study Start Date :

Apr 1, 1999

Actual Primary Completion Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
3	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
4	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
5	University of Colorado Cancer Center	Denver	Colorado	United States	80010
6	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
7	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
8	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
9	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
10	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
11	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
12	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
13	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
14	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
15	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
16	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
17	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
18	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
19	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
20	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
21	Schneider Children's Hospital at North Shore	Manhasset	New York	United States	11030
22	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
23	University of Rochester Cancer Center	Rochester	New York	United States	14642
24	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-7775
25	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
26	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
27	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
28	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45267-0502
29	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
30	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
31	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
32	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
33	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
34	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
35	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
36	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
37	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
38	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
39	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
40	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
41	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
42	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
43	Tacoma General Hospital	Tacoma	Washington	United States	98405
44	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2