A randomized controlled trial of treatment planning process to enhance shared decision-making in patients with metastatic breast cancer.

Abstract

311 Background: A unique opportunity exists for patients with metastatic breast cancer (MBC) to engage in shared decision-making. Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment planning decision may improve patient engagement in MBC treatment decisions. This study tested the impact of a patient-reported data-driven, oncologist-engaged, shared decision-making treatment planning process compared to the standard treatment planning process. Methods: This randomized controlled trial tested a novel treatment planning process focused on shared decision-making, including oncologist review of patient-reported data and treatment preferences (e.g., impact on daily activities, financial concerns), prior to or during treatment decisions compared to the standard of care treatment planning process where this data was infrequently viewed and treatment plans were delivered as education following decisions. The trial was conducted in women with metastatic breast cancer receiving cancer treatment at a single National Cancer Institute-designated comprehensive cancer center. The primary outcome was patient perception of shared decision-making. Secondary outcomes included patient activation, physician perception of treatment decision-making, and physician use of the intervention. Descriptive statistics were calculated for all study outcomes. Cramer’s V and logistic regression models were used to evaluate effect. Subgroup analyses were conducted by race. Results: Among the 109 evaluable patients enrolled from 12/2018-6/2022, median age at consent was 59 years (interquartile range 49-65); 28% were Black, 12% lived in highly disadvantaged neighborhoods, and 24% lived in a rural setting. Patients receiving the intervention had a slightly higher perception of shared decision-making than patients receiving standard of care (63% vs 59%; V=0.05; OR 1.19; 95% CI 0.55-2.57). Among Black patients receiving the intervention, 77% of patients perceived the treatment decision to be shared, compared to 65% of Black patients in the control arm (V=0.10). Almost a third (31%) of patients in the intervention arm were at the highest level of patient activation compared to 19% of those in the control arm (V=0.18). In 82% of decisions, oncologists agreed the patient-reported data helped engagement in shared decision-making and 45% reported changing management due to patient-reported data. Conclusions: Oncologist review of patient-reported data in decision-making may be a promising approach to improve patient activation and patient-centric decision-making, particularly for Black women who may face challenges effectively communicating preferences during treatment discussions. This intervention should be tested in larger studies. Clinical trial information: NCT03806738 .