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. ? ? ?
|Weinfurt, Kevin P; Seils, Damon M; Lin, Li et al. (2012) Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question? J Clin Oncol 30:4396-400|
|Abernethy, Amy P; Wheeler, Jane L; Courtney, Paul K et al. (2011) Supporting implementation of evidence-based behavioral interventions: the role of data liquidity in facilitating translational behavioral medicine. Transl Behav Med 1:45-52|
|Keefe, Francis J (2011) Behavioral medicine: a voyage to the future. Ann Behav Med 41:141-51|
|Lumley, Mark A; Cohen, Jay L; Borszcz, George S et al. (2011) Pain and emotion: a biopsychosocial review of recent research. J Clin Psychol 67:942-68|
|Cassileth, Barrie R; Keefe, Francis J (2010) Integrative and behavioral approaches to the treatment of cancer-related neuropathic pain. Oncologist 15 Suppl 2:19-23|
|Sulmasy, Daniel P; Astrow, Alan B; He, M Kai et al. (2010) The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer 116:3702-11|
|Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P et al. (2008) Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Making 28:575-81|
|Weinfurt, Kevin P (2008) Varieties of uncertainty and the validity of informed consent. Clin Trials 5:624-5;discussion 630|
|Weinfurt, Kevin P (2007) Value of high-cost cancer care: a behavioral science perspective. J Clin Oncol 25:223-7|