Quality of Life Clinical Trial
Official title:
The Impact of Oral Chemotherapy on Quality of Life in Patients With Recurrent Epithelial Ovarian Cancer
RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help
determine the intermediate- and long-term effects of the treatment on these patients.
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.
OBJECTIVES: I. Determine the impact of oral versus parenteral chemotherapy on quality of
life (QOL) in patients with recurrent ovarian epithelial cancer. II. Evaluate the QOL over
time in this patient population. III. Determine the impact of disease symptoms, treatment
side effects, performance status, and CA-125 levels on QOL assessment in this patient
population.
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 Patients are withdrawn from study if treatment regimen is changed from oral to IV,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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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