PATIENT DECISION MARKING--PHASE 1 CLINICAL TRIALS

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Phase I trials are the first step in the clinical development of new cancer therapies. Subjects for phase I studies are generally patients for whom there is no standard therapy of known benefit; this raises significant ethical concerns, given that most patients are treated with subtherapeutic doses, the potential for patient benefit is small and the participating patient population is particularly vulnerable. In addition, potential conflicts of interest may exist since physician and nurse caregivers can also be members of the phase I study team. These issues may compromise a patients ability to adequately participate in the decision making process, lead to the selection of patients for phase I trials driven more by the need to fulfill the goals of research rather than on what is best for the patient, and result in fostering a disparity between what patients, physicians and nurses perceive as the potential risks and benefits of participation. A greater understanding of patient decision making in this context could lead to improvement in methods to support the decision making of patients, research nurses, and physicians involved in phase I clinical investigation. The overall goal of this multidisciplinary, Inter-institutional consortium is to conduct a descriptive cross-sectional study to identify how patients weigh factors that affect decision making concerning participation in phase I clinical trials. The specific aims of this project are 1) to identify factors that influence decision making in patients considering participation in phase I clinical trials; 2) to identify factors that influence physicians and nurses perceptions of the probability of benefit and adverse reactions of patient participation in phase I clinical trials; 3) to determine the impact of decisions about participation (or non-participation) in phase I clinical trials on patient quality of life, and assess satisfaction with decisions made; and 4) to test a novel decision making model developed by the investigators, the HSRA model (Health Stock Risk Adjustment Model) in patients considering phase I trial participation. More than 500 patients with advanced cancer who are offered participation in phase I clinical trials will be recruited for this study. Baseline and 30 month follow- up patient interviews, and surveys of research nurses and physicians for each patient will be conducted. This multi-disciplinary research includes investigators in medical oncology, nursing, health services research, bioethics, and psychology.