The crux of the informed consent process is patients' understanding of pertinent information about their treatment options. Our previous work and that of others has raised concerns about the adequacy of this process. In an earlier NCI-funded study, we found that patients who were offered participation in early phase oncology trials frequently reported high expectations about the benefit of an experimental therapy. If these high expectations reflect false beliefs about the nature of treatment, then they invalidate the patient's consent. It is unclear from the available evidence, however, whether patients are demonstrating faulty knowledge about a treatment every time they express high expectations of benefit. Perhaps patients' high expectations of benefit reflect a different interpretation of probability and/or a different motivation for expressing treatment expectations. Without knowing the meaning of patients' expectations of benefit, one cannot conclude that the informed consent process has failed to ensure the patients' understanding. The objective of this proposal is to better understand the meaning of patients' reported expectations regarding treatment outcomes in the informed consent process. To accomplish this objective, we will pursue 3 Specific Aims: (1) To determine how patients who are offered participation in phase I and II studies understand questions regarding their expectations of treatment outcomes. Study 1 will address this aim using cognitive interviews of patients. (2) To determine how patients' estimates of treatment outcomes depend upon how the patients are asked to provide the estimates. Study 2 will address this aim using an experimental design in which the way patients are queried about their expectations will be manipulated. (3) To describe patient characteristics that are associated with higher expectations regarding treatment outcomes.
This aim will be addressed in the context of Study 2 by assessing different patient characteristics using an interviewer-administered survey. Findings from the proposed research will help to determine if and when patients' reports of treatment expectations indicate a failure of the informed consent process. The results will also be applicable to a broad array of patients who are considering treatment options for life threatening diseases. ? ? ?

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Special Emphasis Panel (ZRG1-HOP-E (50))
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Wu, Roy S
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Duke University
Schools of Medicine
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