title: What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions.
abstract: PURPOSE; Evaluation of the communication and informed consent process in phase I clinical trial interviews to provide authentic, practice-based content for inclusion in a communication skills training intervention for health care professionals.
  
  
  METHODS
  Seventeen oncologists and 52 patients from five United Kingdom cancer centers consented to recording of phase I trial discussions. Following each consultation, clinicians completed questionnaires indicating areas they felt they had discussed, and researchers conducted semistructured interviews with patients examining their recall and understanding. Patients and oncologists also completed the Life Orientation Test-Revised questionnaire, measuring predisposition toward optimism. Independent researchers coded the consultations identifying discussion of key information areas and how well this was done. Observed levels of agreement were analyzed for each consultation between oncologist-coder, oncologist-patient, and patient-coder pairs.
  
  
  RESULTS
  In several key areas, information was either missing or had been explained but was interpreted incorrectly by patients. Discussion of prognosis was a frequent omission, with patients and coders significantly more likely to agree that oncologists had not discussed it (odds, 4.8; P < .001). In contrast, coders and oncologists were more likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .023).
  
  
  CONCLUSIONS
  These data indicate that fundamental components of communication and information sharing about phase I trial participation are often missing from interviews. Important omissions included discussion of prognosis and ensuring patient understanding about supportive care. These findings will inform educational initiatives to assist communication about phase I trials.
authors.affiliation: Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom BN9 1QG. val@sussex.ac.uk
authors.forename: Valerie
authors.initials: V
authors.lastname: Jenkins
authors.forename: Ivonne
authors.initials: I
authors.lastname: Solis-Trapala
authors.forename: Carolyn
authors.initials: C
authors.lastname: Langridge
authors.forename: Susan
authors.initials: S
authors.lastname: Catt
authors.forename: Denis C
authors.initials: DC
authors.lastname: Talbot
authors.forename: Lesley J
authors.initials: LJ
authors.lastname: Fallowfield
mesh_terms: D000328:Adult; D000368:Aged; D017321:Clinical Trials, Phase I as Topic / Q000379:methods* / Q000523:psychology*; D003142:Communication; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D010817:Physician-Patient Relations; D011379:Prognosis; D011795:Surveys and Questionnaires