How do patients and physicians cope with four Patients Informed Consent Forms (ICFs) and the complexity of MINDACT?
The MINDACT clinical trial is a complex trial based on an innovative tool. Because of this the four ICFs have been written with great care – and reviewed by patient groups – to best inform patients. We have also produced a DVD with a London based company called Windfall Digital. The aims of the DVD are to explain the trial to eligible women after they have had surgery to remove the tumour and to help them decide to participate or not in this complex trial. The DVD is used in consultation with a physician or research nurse, and guides women through the different parts of the MINDACT trial, explaining the three randomizations and devoting extended time to the first randomization. This is the most complex randomization when risk is assessed with the classical clinical-pathological criteria versus the genomic risk done with the 70 gene signature MammaprintTM.
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