IBIS-II Decision aid randomised controlled trial

Start Year: 2008
Finish Year: 2008
Chief Investigator: Professor Phyllis Butow
Grant Type: Translational Grant
Institution: University of Sydney

National Translational Research Grants Program

In 2005 the University of Sydney’s Medical Research Unit (MRU) received funding to evaluate the utility of a decision aid (DA) for women considering participation in the IBIS-II trial. This project is the first study internationally to assess the effectiveness of a DA to improve informed consent to a clinical trial.

The primary aims of the project are to determine whether the DAs will reduce decisional conflict and increase satisfaction with the decision to participate or not in the trial, and increase participant’s knowledge about their risk management options. The secondary aim is to investigate the effect of the DA provision on participant accrual to IBIS-II and participant drop-out from treatment.

Support for this study to date has been enormous amongst both the consumers and recruiters involved in IBIS-II. As consumer demand for medical decisions grow, this work will have increasing application both in breast and other fields.