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

Ovarian Cancer Clinical Trial

Official title:

Quality of Life in Ovarian Germ Cell Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003794
• Other study ID #: CDR0000066937
• Secondary ID: GOG-9901
• Status: Terminated
• Phase: N/A
• First received: November 1, 1999
• Last updated: June 7, 2013
• Start date: April 1999

Study information

• Verified date: November 2005
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Chao Family Comprehensive Cancer Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Monahan PO, Champion VL, Zhao Q, Miller AM, Gershenson D, Williams SD, Cella D. Case-control comparison of quality of life in long-term ovarian germ cell tumor survivors: a gynecologic oncology group study. J Psychosoc Oncol. 2008;26(3):19-42. — View Citation

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.