title: The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.
abstract: BACKGROUND
  Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent.
  
  
  METHODS
  The authors interviewed 45 patients enrolled in phase 1 or 2 oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. They used a phenomenological, qualitative approach with 1 primary coder to identify emergent themes, verified by 2 independent coders.
  
  
  RESULTS
  Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27 of 45 participants used 1 of these words. Three major themes emerged: 1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; 2) fighting cancer as a battle; and 3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P=.04).
  
  
  CONCLUSIONS
  Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early phase clinical trials.
authors.affiliation: Department of Medicine, MacLean Center for Clinical Medical Ethics, Divinity School, University of Chicago, Chicago, Illinois 60637, USA. dsulmasy@uchicago.edu
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Sulmasy
authors.forename: Alan B
authors.initials: AB
authors.lastname: Astrow
authors.forename: M Kai
authors.initials: MK
authors.lastname: He
authors.forename: Damon M
authors.initials: DM
authors.lastname: Seils
authors.forename: Neal J
authors.initials: NJ
authors.lastname: Meropol
authors.forename: Ellyn
authors.initials: E
authors.lastname: Micco
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Weinfurt
mesh_terms: D001294:Attitude to Health; D002986:Clinical Trials as Topic; D032882:Comprehension; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy*; D018579:Patient Selection; D012068:Religion and Medicine; D055990:Therapeutic Misconception / Q000941:ethics*