Informed consent requires further study, and pediatric oncology is the ideal context for the conduct of such research. The primary goal of this study is to improve the quality of informed consent for childhood cancer trials. The project will take place as a limited-institution study within the Children's Oncology Group, the single pediatric member of the NCI's Clinical Trials Cooperative Group Program. The long-term objective will be to capitalize on our understanding of consent to yield generalizable findings that can be implemented to improve consent in clinical trials across various diseases and all age groups. The research plan is based on the premise that specific outcome measures and rigorous scientific methodology are required to accurately study the complex interaction that is informed consent. The work accomplished to date has allowed us to refine this methodology, select key outcome measures, and develop rational intervention plans; it is the foundation upon which this competitive renewal proposal is based.
The Specific Aims of the project are: 1) To utilize our scientific understanding of the informed consent process in childhood leukemia trials to further develop, test and implement two databased interventions to improve informed consent: a) a physician-directed intervention based on teaching improved management of the informed consent conference, and b) a parent-directed intervention based on the model of anticipatory guidance for informed consent; 2) To conduct a clinical trial to test the effect of each intervention on three specific outcomes: a) parental comprehension of choice and alternative to clinical trial participation, b) parental understanding of randomization, and c) parental participation during the informed consent process as measured by the number and quality of questions asked by parents, and; 3) To determine if either intervention is superior to a control group, and how the two interventions compare to one another. This clinical trial of two rational, data-driven interventions will allow us to act on what we have learned, to determine whether we can improve informed consent.
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