title: Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.
abstract: BACKGROUND
  Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial.
  
  
  METHODS
  The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up).
  
  
  RESULTS
  Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up.
  
  
  CONCLUSIONS
  This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
authors.forename: I
authors.initials: I
authors.lastname: Juraskova
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Butow
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Bonner
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
authors.forename: M L
authors.initials: ML
authors.lastname: Bell
authors.affiliation: Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
authors.forename: A B
authors.initials: AB
authors.lastname: Smith
authors.affiliation: Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Seccombe
authors.affiliation: 1] Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia [2] Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia [3] Pam McLean Centre, The University of Sydney, Sydney 2006, Australia.
authors.forename: F
authors.initials: F
authors.lastname: Boyle
authors.affiliation: Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
authors.forename: L
authors.initials: L
authors.lastname: Reaby
authors.affiliation: Cancer Research UK, Department of Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary College, University of London, London E1 4NS, UK.
authors.forename: J
authors.initials: J
authors.lastname: Cuzick
authors.affiliation: Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
authors.forename: J F
authors.initials: JF
authors.lastname: Forbes
mesh_terms: D001943:Breast Neoplasms / Q000517:prevention & control*; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000523:psychology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome