From Clinical Reality to Blueprint Designing: A Qualitative Study Exploring Communication Challenges and Unmet Needs for Patient Decision Aid Development in Early-Stage Breast Cancer

INTRODUCTION: A diagnosis of early-stage Breast Cancer (BC) induces significant psychological distress in patients, who are then required to make complex treatment decisions. Evidence-based tools like Patient Decision Aids (PDAs) have been proposed as tools to support communication and Shared Decision-Making (SDM). However, their successful use in clinical practice depends also on real-world consultation dynamics. Existing literature suggests that insufficient attention to contextual and user-centered factors may limit the relevance and uptake of PDAs. A bottom-up approach grounded in clinical reality may therefore be essential to inform their design and future integration into care. AIMS: This study aimed to explore experiences, unmet needs and expectations of both patients and healthcare professionals involved in early-stage breast cancer care regarding decision-making support and standard oncological consultations, in order to identify patient- and clinician-derived design requirements for a future PDA supporting shared treatment decision-making in early-stage breast cancer. METHODOLOGY: We conducted 52 semi-structured interviews with 20 patients and 32 HCPs at the European Institute of Oncology in Milan from 10 January 2025 to 30 August 2025. Interviews were transcribed and analyzed using thematic analysis, with coding performed by two independent researchers and discrepancies resolved through independent discussion with two other authors. RESULTS: HCPs highlighted three key themes: variability in patient information needs, misconceptions about treatments (especially chemotherapy and radiotherapy), and the multifactorial nature of treatment decisions. Patients emphasized the importance of trust in physicians, the need for practical information on side effects and coping strategies, and the role of peer support, often found through informal networks or social media. These findings identified preliminary requirements for a future PDA: adaptable information depth and timing; plain-language responses to common misconceptions; structured values-clarification prompts; practical preparation and side-effect-management information; signposting to vetted psychosocial and peer-support resources. CONCLUSIONS: Findings highlight communication challenges and unmet psychosocial and informational needs within standard oncological consultations for early-stage breast cancer. By grounding decision support development in the perspectives of both patients and healthcare professionals, this study provides formative, pre-implementation insights to guide the design of PDAs that are responsive to real-world clinical contexts and patient experiences. TRIAL REGISTRATION: clinicaltrials.gov, identifier: NCT06762496. Registered 7th January 2025 -https://clinicaltrials.gov/study/NCT06762496.