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.
背景：尽管早期乳腺癌(eBC)的新疗法近期取得进展，但当前治疗模式对患者生活质量的影响仍不明确。本研究探讨了eBC女性的患病体验与未满足需求，并据此构建了总结患者优先关注点的患者知情概念疾病模型(PI-CDM)。 方法：本定性研究采用分步法：(1)定向文献综述；(2)CDM草案制定；(3)访谈提纲设计；(4)对美国eBC确诊女性进行半结构化访谈；(5)访谈文本的主题内容分析；(6)患者指导委员会意见整合；(7)PI-CDM最终定稿。 结果：2023年12月至2024年5月期间共访谈36名eBC女性（I期18人，II期11人，III期9人）。核心健康概念包括导致确诊的体征症状及常见治疗副作用。情感与心理影响尤为突出，EQ-5D-5L量表显示28名参与者存在中度至极重度焦虑或抑郁。其他影响涉及社交生活、身体满意度、日常活动、躯体功能、性功能及财务状况。患者特别强调需要医疗提供者改进治疗方案沟通并加强支持。这些发现结合患者指导委员会建议，最终形成PI-CDM。 结论：本研究揭示了eBC女性承受的重大负担，为未来以患者为中心的研究提供框架。与患者共同构建的CDM概括了eBC体验的复杂性，有助于促进医患沟通，推动共同决策以优化诊疗。
肿瘤(癌症)患者之家