The "Preparation for Shared Decision-Making" Tool for Women With Advanced Breast Cancer: Qualitative Validation Study.

Background: The range of decisions and considerations that women with advanced breast cancer (ABC) face can be overwhelming and difficult to manage. Research shows that most patients prefer a shared decision-making (SDM) approach as it provides them with the opportunity to be actively involved in their treatment decisions. The current engagement of these patients in their clinical decisions is suboptimal. Moreover, implementing SDM into routine clinical care can be challenging as patients may not always feel adequately prepared or may not expect to be involved in the decision-making process.

Objective: Avalere Health developed the Preparation for Shared Decision-Making (PFSDM) tool to help patients with ABC feel prepared to communicate with their clinicians and engage in decision making aligned with their preferences. The goal of this study was to validate the tool for its acceptability and usability among this patient population.

Methods: We interviewed a diverse group of women with ABC (N=30). Interviews were audiorecorded, transcribed, and double coded by using NVivo. We assessed 8 themes to understand the acceptability and usability of the tool.

Results: Interviewees expressed that the tool was acceptable for preparing patients for decision making and would be useful for helping patients know what to expect in their care journey. Interviewees also provided useful comments to improve the tool.

Conclusions: This validation study confirms the acceptability and usability of the PFSDM tool for women with ABC. Future research should assess the feasibility of the tool's implementation in the clinical workflow and its impact on patient outcomes.