A pilot study on an idiographic assessment of quality of life in patients enrolled in phase I clinical trials.

250 Background: Patient centered quality of life (QOL) is pivotal in treatment decision making for poor prognoses and recurrent solid tumors. Data regarding the best methods of QOL assessment for patients receiving chemotherapy for high risk cancers and enrolled in Phase I trials are sparse. We therefore piloted a QOL assessment that incorporated a validated metric as well as a novel “idiographic” questionnaire. Methods: Twenty-five women with high risk gynecologic malignancies (defined as < 30% five year survival) and 10 patients enrolled in Phase I clinical trials were recruited after IRB approval was obtained. Patients’ answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-30) and “idiographic” QOL assessment were recorded and decoded. Raw scores of the QLQ-30 were standardized using linear transformation. Statistical analysis was performed using Mann-Whitney U and Chi-square testing with SPSS software. Results: Idiographic assessment re...