Abstract
INTRODUCTION: Early breast cancer (BC) detection enhances survival, with treatment options influenced by cancer stage, pathological characteristics and patient preferences. Patient decision aids (PDAs) promote shared decision-making (SDM), enhancing patients' engagement, adherence to treatment and satisfaction. However, few PDAs for early-stage BC patients exist in the Italian context. METHODS AND ANALYSIS: A first developmental phase will include a systematic review on current PDAs and semistructured interviews with patients and healthcare professionals. Outcomes will be used to develop a first draft of PDA. Following international guidelines, the PDA will be sent to patients to gather first qualitative feedback and subsequently quantitative feedback regarding the attractiveness, usability and comprehensibility of the tool and patients' health literacy. Once having reached a final version of PDA, a pilot randomised controlled trial study will be implemented: a control group will receive standard care (n=75) and an experimental group (n=75) will receive standard care and the PDA. Depression, anxiety, SDM, quality of life (QoL) and distress levels will be assessed through validated questionnaires in both groups at three different time points. Measures will include attractiveness, usability and comprehensibility of the PDA as well as efficacy measures assessed through evaluation of patients' levels of anxiety, depression, distress and QoL. ETHICS AND DISSEMINATION: This protocol was approved by the ethical committee Comitato Etico Territoriale Lombardia 2 of the Istituto di Ricovero e Cura a Carattere Scientifico European Institute of Oncology (L2-253; approved in November 2024). All participants will be given written and verbal information, and informed consent will be obtained from all participants across all phases of our project. Participation in the study will be fully voluntary. All the methodologies mentioned in this protocol will be carried out according to both national and international declarations, guidelines and regulations compliant with proper ethical research involving human subjects. Results will be published in peer-reviewed journals, through traditional academic pathways. This protocol study has been registered on clinicaltrials.gov in January 2025 (Identifier: NCT06762496). TRIAL REGISTRATION NUMBER: NCT06762496.