title: Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies.
abstract: OBJECTIVE
  Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies.
  
  
  METHODS
  Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies.
  
  
  RESULTS
  Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences.
  
  
  CONCLUSIONS
  Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions.
authors.affiliation: Department of Social and Behavioral Health, Virginia Commonwealth University School of Medicine, Richmond, VA 23298-0581, USA. rbrown39@vcu.edu
authors.forename: Richard
authors.initials: R
authors.lastname: Brown
authors.forename: Carma L
authors.initials: CL
authors.lastname: Bylund
authors.forename: Laura A
authors.initials: LA
authors.lastname: Siminoff
authors.forename: Susan F
authors.initials: SF
authors.lastname: Slovin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017321:Clinical Trials, Phase I as Topic; D003142:Communication; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008495:Medical Oncology / Q000592:standards; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology / Q000628:therapy; D018579:Patient Selection; D010817:Physician-Patient Relations; D010820:Physicians; D014481:United States