title: Development and piloting of a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 breast cancer trial.
abstract: OBJECTIVE
  This study aimed to (1) develop a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 (SNAC-2) breast cancer surgical trial and (2) obtain evidence on its acceptability, feasibility, and potential efficacy in routine trial clinical practice via a two-stage pilot.
  
  
  METHODS
  The decision aid was developed according to International Patient Decision Aid Standards. Study 1: an initial pilot involved 25 members of the consumer advocacy group, Breast Cancer Network Australia. Study 2: the main pilot involved 20 women eligible to participate in the SNAC-2 trial in New Zealand. In both pilots, a questionnaire assessed: information and involvement preferences, decisional conflict, SNAC-2 trial-related understanding and attitudes, psychological distress, and general decision aid feedback. A follow-up telephone interview elicited more detailed feedback on the decision aid design and content.
  
  
  RESULTS
  In both pilots, participants indicated good subjective and objective understanding of SNAC-2 trial and reported low decisional conflict and anxiety. The decision aid was found helpful when deciding about trial participation and provided additional, useful information to the standard trial information sheet.
  
  
  CONCLUSIONS
  The development and two-stage piloting process for this decision aid resulted in a resource that women found very acceptable and helpful in assisting decision-making about SNAC-2 trial participation. The process and findings provide a guide for developing other trial decision aids.
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia ilona.juraskova@sydney.edu.au.
authors.forename: Ilona
authors.initials: I
authors.lastname: Juraskova
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Phyllis
authors.initials: P
authors.lastname: Butow
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Alana
authors.initials: A
authors.lastname: Fisher
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Carissa
authors.initials: C
authors.lastname: Bonner
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Caroline
authors.initials: C
authors.lastname: Anderson
authors.affiliation: Centre for Medical Psychology and Evidence-Based Decision Making (CeMPED), School of Psychology, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Stella
authors.initials: S
authors.lastname: Bu
authors.affiliation: Breast Cancer Centre, Waikato Hospital, Hamilton, New Zealand.
authors.forename: Jenni
authors.initials: J
authors.lastname: Scarlet
authors.affiliation: NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Stockler
authors.affiliation: Princess Alexandra Hospital, Brisbane, QLD, Australia.
authors.forename: Neil
authors.initials: N
authors.lastname: Wetzig
authors.affiliation: Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia Faculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, QLD, Australia.
authors.forename: Owen
authors.initials: O
authors.lastname: Ung
authors.affiliation: Breast Cancer Centre, Waikato Hospital, Hamilton, New Zealand.
authors.forename: Ian
authors.initials: I
authors.lastname: Campbell
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000601:surgery*; D002986:Clinical Trials as Topic; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology*; D010865:Pilot Projects; D021701:Sentinel Lymph Node Biopsy; D011795:Surveys and Questionnaires
keywords: Decision aid (DA); Sentinel Node Biopsy versus Axillary Clearance 2; axillary clearance; breast cancer; clinical trial participation; informed consent; sentinel node biopsy