Abstract
Background: Despite recent advances in new therapies for early-stage breast cancer (eBC), the impact of the current treatment landscape on patients' quality of life remains poorly understood. This study explored the experiences and unmet needs of women with eBC, leading to the development of a patient-informed conceptual disease model (PI-CDM) that summarizes patient priorities. Methods: This qualitative study used a step-wise approach: (1) a targeted literature review; (2) draft CDM development; (3) interview guide development; (4) semi-structured interviews with women in the United States with a diagnosis of eBC; (5) thematic content analysis of interview transcripts; (6) patient steering committee insights; and (7) PI-CDM finalization. Results: Thirty-six women with eBC (stage I, n = 18; stage II, n = 11; stage III, n = 9) were interviewed between December 2023 and May 2024. Key health concepts included signs and symptoms leading to diagnosis and common treatment side effects. Emotional and psychological impacts were prominent, and 28 participants reported moderate to extremely severe anxiety or depression on the EQ-5D-5L. Other impacts included social life, body satisfaction, daily activities, physical functioning, sexual functioning, and finances. Needs for improved communication from healthcare providers about treatment options and better support were emphasized. These insights, combined with patient steering committee recommendations, resulted in a final PI-CDM. Conclusions: This study highlights the substantial burden women with eBC face and provides a framework for future patient-centric research. A CDM developed with patients summarizes the complexity of the eBC experience and can aid discussions between patients and physicians, facilitating shared decision-making to enhance care.