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

Abstract

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 resulted in 100 goal statements in 17 domains from patients in Phase I trials as compared to 260 goals in 20 domains from patients with high risk gynecologic malignancies. There were no differences in goal attainment or satisfaction with attainment between groups. There was a trend toward increased number of autonomy directed goals in the high risk group versus Phase I participants (23% vs. 11%, p=0.07) Median scores on functional (71 high risk vs. 84 Phase I) and global health status (58 high risk vs. 67 Phase I) scales were not different between the two groups. However, higher symptom burden was reported by the high risk group as compared to the median Phase I score (51 vs. 27, p<0.01) Conclusions: There is a complex relationship between treatment decision-making and QOL for patients diagnosed with poor prognoses cancers. Further research is needed to better define QOL indicators and the impact of treatment on patient centered QOL.