Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003794
Recruitment Status : Terminated
First Posted : October 29, 2003
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief Summary:

RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer.

PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.

Condition or disease Intervention/treatment
Ovarian Cancer Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Detailed Description:

OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables.

OUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life.

PROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.

Study Type : Observational
Official Title: Quality of Life in Ovarian Germ Cell Cancer Survivors
Study Start Date : April 1999
Actual Primary Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: History of early or advanced ovarian germ cell tumors Continuously disease free for at least 2 years prior to study Must have been enrolled on GOG protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at M.D. Anderson Cancer Center

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete a written questionnaire and telephone interview in English

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003794

United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Illinois
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Stephen D. Williams, MD Indiana University Melvin and Bren Simon Cancer Center

Publications of Results:
Williams SD, Miller AM, Cella D, et al.: Relationship issues and sexual functioning in ovarian germ cell cancer survivors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-845, 2001. Identifier: NCT00003794     History of Changes
Other Study ID Numbers: CDR0000066937
First Posted: October 29, 2003    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: November 2005

Keywords provided by Gynecologic Oncology Group:
stage I ovarian germ cell tumor
stage II ovarian germ cell tumor
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor

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