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Study Summary
No. 2007-0611:.......Ovary......Michael M. Frumovitz......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		2007-0611
Study Title:Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer
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Physician New Patient Referral
Name:Michael M. FrumovitzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-9599
Contact us about clinical trials
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General Information
Disease Group:OvarySupported By:Blanton/Davis Ovarian Cancer Research Program, Sprint for Life Award
Phase of Study:N/AReturn
Visit:		n/a
Treatment
Agents:		QuestionnaireHome Care:completion of some questionnaires/patient diaries
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		The goal of this research study is to learn about the quality of life and
sexual functioning of women with platinum-resistant ovarian cancer as they
receive other treatments for the disease.

Researchers will study the costs for chemotherapy treatments, other medical
expenses, and treatment-related expenses that are not medical. Researchers
will also review any symptoms these patients may experience related to the
cancer or treatment.

In addition, researchers want to learn if and how these patients' caregivers
feel the status of these patients' health may have affected the caregivers'
productivity at work and at home.
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Study Objectives / Outcomes
Primary Objective

1. To longitudinally measure quality of life and sexual functioning and assess symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens

Secondary Objectives

1. To determine costs associated with receiving multiple second-line treatments for ovarian cancer
2. To determine quality-adjusted life years for women receiving second-line treatment for ovarian cancer
3. To perform a cost-utility analysis for second-line therapies in women with recurrent, platinum-resistant ovarian cancer
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Study Status Information
Study Activation / Registration Date:12/11/2008
IRB Review and Approval Date:01/28/2008
Study Type:Behavioral
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment

2) Patients must be English-speaking

3) Patients must be able to read and write English

4) Patients receiving some of all chemotherapy at MD Anderson Cancer Center
Exclusion Criteria:1) Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary

2) Patients who are receiving protocol therapy

3) Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)

4) Patients who are receiving radiation therapy as a treatment modality
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Links
Registration Number: NCT00813254
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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