EFFECTS OF ALTERING THE TIME OF ADMINISTRATION AND THE TIME FRAME OF QUALITY-OF-LIFE ASSESSMENTS IN CLINICAL-TRIALS - AN EXAMPLE USING THE EORTC QLQ-C30 IN A LARGE ANTIEMETIC TRIAL

Previous studies conducted by our group suggested that the ability to demonstrate an impact of emesis control on quality of life might depen d upon when an quality of life instrument was administered in relation to chemotherapy and on the time frame of the questionnaire. This stud y was conducted to address this issue. Six hundred and fifty patients receiving moderately emetogenic chemotherapy in a randomized trial com paring a variety of anti-emetic regimens were allocated to four differ ent modes of administration (days 4 and 8; 3 and 7 day time frames) of the QLQ-C30. Patients who completed the questionnaire at the time of maximal impact of chemotherapy (day 3) were more likely to report dete rioration in quality of life. Patients who completed questionnaires at day 8 were more likely to report deterioration in quality of life if their questionnaire had a 7 day time frame rather than a 3 day time fr ame. Patients receiving more effective antiemetic therapy had better q uality of life. It was concluded that better anti-emetic control impro ves quality of life after moderately emetogenic chemotherapy. In study ing quality of life in situations where the impact of treatment waxes and wanes, careful attention needs to be paid to scheduling the admini stration of questionnaires and to their time frame. (C) 1998 Lippincot t-Raven Publishers.