SNAC2 Decision Aid Study

4 June 2015

Purpose

The purpose of this study is to evaluate the usefulness of a decision aid booklet to assist women who are considering participation in the Sentinel Node biopsy versus Axillary Clearance Part 2 trial. Note the above SNAC 1 trial introduced sentinel node biopsy to women with small and unifocal (one focus) breast cancer. SNAC2 (see trials in follow-up) is investigating sentinel node biopsy for larger and/or multifocal (more than one) breast cancer.

Scientific title

Improving informed consent: The development and pilot of a decision aid for women invited to participate in the Sentinel Node biopsy versus Axillary Clearance Part 2 (SNAC 2) trial

Background

As clinical trials are increasing in complexity, trial consent documents have become longer and more difficult to understand. Limited doctor-patient communication and patient understanding of the clinical trial rationale and procedure may not only compromise patient recruitment but also the process of informed consent. Decision aids (DAs) can potentially address this issue by improving patient understanding in the clinical trial setting.

Results

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.

Publication

Development and piloting of a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 (SNAC2) trial: A three-stage process to inform future trial decision aids. Ilona Juraskova, Phyllis Butow, Alana fisher, Carissa Bonner, Caroline Anderson, Jenni Scarlet, Martin Stockler, Neil Wetzig, Owen Ung and Ian Campbell. Clinical Trials; 4 June, 2015