Oral Presentation Clinical Oncology Society of Australia 2014 Annual Scientific Meeting

“Not just following what doctors say”: piloting of a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 (SNAC2) trial. (#98)

Alana Fisher 1 , Ilona Juraskova 1 , Phyllis Butow 1 , Carissa Bonner 1 , Caroline Anderson 1 , Jenni Scarlet 2 , Martin Stockler 3 , Neil Wetzig 4 , Owen Ung 5 6 , Grantley Gill 7 , Ian Campbell 2
  1. School of Psychology, Centre for Medical Psychology & Evidence-based Decision-making (CeMPED), University of Sydney, Sydney, NSW, Australia
  2. Breast Cancer Centre, Waikato Hospital, Hamilton, New Zealand
  3. NHMRC Clinical Trials Centre, The University of Sydney , Sydney, NSW, Australia
  4. Princess Alexandra Hospital, Brisbane, QLD, Australia
  5. Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia
  6. Faculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, QLD, Australia
  7. Royal Adelaide Hospital, Adelaide, SA, Australia

Aims. Suboptimal understanding of clinical trial-related information may not only compromise accrual, but also the informed consent process. Decision aids (DAs) enhance patient understanding and decision-making in treatment and screening settings, but only one previous trial has formally evaluated DA use in the clinical trial setting. A DA for the Sentinel Node versus Axillary Clearance (SNAC2) trial was developed to help eligible women with a recent diagnosis of breast cancer to decide between: 1) a more invasive, standard treatment with known potential side-effects, or 2) a randomised trial comparing option 1 to a less invasive treatment with fewer side-effects but a possible small, but higher risk of local recurrence. The pilot aimed to obtain evidence on the acceptability, utility and feasibility of the DA in routine trial clinical practice for women considering participation in the SNAC2 trial.

Methods. The DA was developed according to International Patient Decision Aid Standards (IPFAS) and discussions with key stakeholders. Twenty women eligible to participate in the SNAC2 trial in New Zealand completed questionnaires assessing: information and involvement preferences, decisional conflict, understanding and attitudes towards SNAC2, anxiety, and general DA feedback. A follow-up telephone interview elicited more detailed feedback about the DA's design, clarity and utility, and assessed women's knowledge about, and attitudes towards SNAC2.

Results. Participants indicated good subjective and objective understanding of SNAC2 and reported low decisional conflict and anxiety. They found the DA booklet was helpful when deciding about trial participation; facilitated understanding of the standard information sheet; and provided additional, useful information to the standard trial information sheet.

Conclusions. Findings suggest that the DA provided a resource that women found acceptable and helpful in assisting decision-making about SNAC2 trial participation. The pilot process and findings support the generalisability and applicability of the trial DA design to other clinical trial settings.