Effect of Chemotherapy Given Either by Mouth or by Infusion on the Quality of Life of Patients With Recurrent Ovarian Epithelial Cancer
NCT ID: NCT00004909
Last Updated: 2011-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
1999-11-30
2002-11-30
Brief Summary
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PURPOSE: This clinical trial studies the effects of chemotherapy given by mouth versus chemotherapy given by infusion on quality of life in patients with recurrent ovarian epithelial cancer.
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Detailed Description
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OUTLINE: Patients receive a baseline quality of life (QOL) assessment, an attitudes/preference survey, and a performance status assessment at the time of diagnosis of recurrent disease. Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines, prior treatment history, and patient preference. QOL and performance status assessments are obtained again at 3 and 6 months during treatment. Attitudes/preferences are assessed at 6 months. Patients are withdrawn from study if treatment regimen is changed from oral to IV, or from IV to oral during this 6 months.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study over 12 months.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Oral chemotherapy
No interventions assigned to this group
Parenteral chemotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Northwestern University
Principal Investigators
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Elizabeth Calhoun, PhD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-98Q3
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1694
Identifier Type: -
Identifier Source: secondary_id
NU 98Q3
Identifier Type: -
Identifier Source: org_study_id
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