title: Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology.
abstract: BACKGROUND
  The purpose of this study was to systematically compare two audiotape formats for the delivery of information relevant to informed consent to participate in a clinical trial in breast oncology, and to establish the feasibility of adding a consultation recording protocol to a clinical treatment trial.
  
  
  METHODS
  Participants were 69 women with newly diagnosed breast cancer and 21 oncologists from 5 Canadian cancer centers. Patients were block randomized to one of three groups: 1. standardized audiotape; 2. consultation audiotape; or 3. both audiotapes. Patients received their tapes immediately following the clinical trial consultation. Patient outcomes included perception of being informed about clinical trials, knowledge of information relevant to providing informed consent to a clinical trial, and satisfaction with communication during the consultation.
  
  
  RESULTS
  The consultation audiotapes contained less trial-related information than the standardized audiotape but there were no differences in clinical trial knowledge or perception of being informed across the intervention groups. Patients expressed a marginally significant preference for consultation audiotapes over standardized audiotapes.
  
  
  CONCLUSIONS
  Patients tended to prefer receiving an audiotape of their own consultation over a standardized audiotape. The majority of oncologists considered the audiotape intervention feasible but were less enthusiastic about being involved in a larger study given the accrual challenges that arose when trying to "piggy-back" one randomized controlled trial on an existing clinical trial.
authors.affiliation: Faculty of Nursing, University of Manitoba, St. Boniface Hospital Research Centre, 351 Tache Avenue, Winnipeg, MB, Canada. thack@sbrc.ca
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Hack
authors.forename: Tim
authors.initials: T
authors.lastname: Whelan
authors.forename: Ivo A
authors.initials: IA
authors.lastname: Olivotto
authors.forename: Lorna
authors.initials: L
authors.lastname: Weir
authors.forename: Barry D
authors.initials: BD
authors.lastname: Bultz
authors.forename: Bryan
authors.initials: B
authors.lastname: Magwood
authors.forename: Fred
authors.initials: F
authors.lastname: Ashbury
authors.forename: Jane
authors.initials: J
authors.lastname: Brady
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000523:psychology*; D003142:Communication; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D017060:Patient Satisfaction; D012017:Referral and Consultation; D013637:Tape Recording