title: Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations.
abstract: BACKGROUND
  Accepted practices of informed consent often result in suboptimal patient understanding of research studies.
  
  
  METHODS
  This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial.
  
  
  RESULTS
  There were no major differences between groups. Participants rated tailored materials higher as a useful reference.
  
  
  CONCLUSIONS
  Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.
authors.affiliation: Department of Community Health, Saint Louis University School of Public Health, St. Louis, MO 63104, USA. wray@slu.edu
authors.forename: Ricardo J
authors.initials: RJ
authors.lastname: Wray
authors.forename: Jo Ellen
authors.initials: JE
authors.lastname: Stryker
authors.forename: Eric
authors.initials: E
authors.lastname: Winer
authors.forename: George
authors.initials: G
authors.lastname: Demetri
authors.forename: Karen M
authors.initials: KM
authors.lastname: Emmons
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000523:psychology*; D032882:Comprehension; D032962:Consent Forms; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000523:psychology*; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D010865:Pilot Projects; D035842:Research Subjects / Q000523:psychology*