Women diagnosed with large or highly proliferative operable breast cancer may be offered neoadjuvant systemic therapy (NAST) for reasons including downstaging, prognostication or expanding surgical options. We aimed to systematically develop, and evaluate a DA for women who had been offered NAST.
Eligible women who were considered candidates for NAST, from four Australian recruiting centres were enrolled in a single arm longitudinal study. Participants completed online questionnaires prior to accessing the DA, and on three occasions post-DA. Primary outcomes were feasibility of use, and acceptability to patients and clinicians. Secondary outcomes were patient reported measures relevant to patient decision-making.
Seventy-nine women were offered study participation and 59 enrolled. Patients were typically well educated, married, had health insurance and were information seekers (mean information needs: 7.5/10; SD 1.84). 59/79 (74.7%) patients who were offered study participation accessed the DA and 49 (79.7%) of those 59 participants reported having read it. 41/51 (80.4%) participants who completed the post-DA assessment reported that the DA helped them with their decision about NAST. 51/59 (86%) participants elected to receive NAST. 16/18 (88.9%) investigators would continue to use the DA in routine practice. Post-DA, decisional conflict decreased significantly across all subscales (p
Study primary outcomes were positive, showing the DA was feasible and acceptable to patients and clinicians. Improvements in decision-related outcomes were demonstrated, and the DA could be included in routine workflow. This DA can be implemented into routine clinical practice for women with operable breast cancer who are candidates for NAST.
Clinical trial identification
Registration: Australia and New Zealand Clinical Trials Registry (www.anzctr.org.au): ACTRN12614001267640
Legal entity responsible for the study
Australia and New Zealand Breast Cancer Trials Group
HCF Research Foundation Australia and New Zealand Breast Cancer Trials Group
All authors have declared no conflicts of interest.