Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (ShaDES)

改善乳腺癌患者以患者为中心的沟通：共享决策参与系统 (ShaDES) 的随机对照试验

• 批准号: 9884260
• 负责人: SARAH T HAWLEY
• 金额: $ 57.52万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-02 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9884260
• 关键词: Address; Algorithms; Anxiety; Area; Attitude; Benefits and Risks; Breast; Breast Cancer Patient; Breast Cancer Treatment; Breast Oncology; Clinic; Cluster randomized trial; Cognitive; Collaborations; Communication; Community Clinical Oncology Program; Complex; Data; Decision Making; Diagnosis; Emotional; Emotions; Evaluation; Face; Feedback; Floods; Fostering; Future; Health; Intervention; Intervention Studies; Knowledge; Link; Malignant Neoplasms; Mediator of activation protein; Modality; Newly Diagnosed; Online Systems; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Process; Quality-of-Life Assessment; Randomized Controlled Trials; Recommendation; Reporting; Research; Self Efficacy; Self Management; Specialist; Surgical Oncology; Surveys; System; Testing; Time; Translating; Work; base; breast cancer diagnosis; clinical care; cognitive task; dashboard; experience; implementation research; improved; individualized medicine; information processing; innovation; malignant breast neoplasm; overtreatment; patient oriented; patient-clinician communication; precision medicine; primary outcome; programs; research clinical testing; response; secondary outcome; statistics; tool; treatment risk

Project Summary/Abstract Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (ShaDES) The diagnosis of breast cancer triggers a cascade of decisions as patients consider multiple treatment modalities navigated by different specialists. Precise evaluative treatment algorithms have better individualized treatment recommendations, [yet sifting through the complexity of the test information and treatment options can be often challenging to patients and can often cause anxiety]. Thus, the advances of precision medicine cannot be realized without parallel advances in patient-centered communication (PCC). This rapidly evolving decision context has fueled a pressing need for more patient-centered communication to address the full breadth of issues—both cognitive and emotional—faced by patients in making breast cancer treatment decisions. There is a critical need for tools that can engage the patient both emotionally and cognitively and be integrated into the breast oncology care clinical workflow. This project is a multi-level, factorial study that crosses a patient-level RCT of 700 newly-diagnosed breast cancer patients within 25 breast surgical oncology practices to evaluate a shared decision engagement system (ShaDES) to support PCC. The system links an emotional support-enhanced version of the research group’s previously developed iCanDecide patient-facing decision tool with a clinic level trial of a Clinician Dashboard to help clinicians address remaining cognitive and emotional needs in their patients. In collaboration with the Alliance NCORP Research Base and its Statistics and Data Core, the trial will: 1) evaluate the impact of the emotional support enhancements to iCanDecide on primary and secondary outcomes measuring patient appraisal of PCC, 2) evaluate the impact of the Clinician Dashboard on patient appraisal of PCC, 3) examine potential mediators of the patient and clinic interventions, and 4) conduct a process evaluation of the two intervention components to inform revision and future widespread implementation of ShaDES. [The results will lay the groundwork for broad implementation of a shared decision engagement system to improve patient-centered communication in breast cancer.]

项目总结/摘要 改善乳腺癌患者以患者为中心的沟通：一项共享决策参与系统的RCT （阴影） 乳腺癌的诊断引发了一系列的决定，因为患者考虑多种治疗 由不同的专家导航的模式。精确的评估治疗算法具有更好的个性化 治疗建议，[但筛选通过测试信息和治疗方案的复杂性 通常会对患者造成挑战，并且通常会引起焦虑]。因此，精准医学的进步 如果没有以患者为中心的沟通（PCC）的并行进展，就无法实现。这个快速发展 决策背景促使人们迫切需要更多以患者为中心的沟通，以解决 乳腺癌患者在接受治疗时所面临的认知和情感问题的广度 决策迫切需要能够在情感和认知上吸引患者的工具， 整合到乳腺肿瘤护理临床工作流程中。该项目是一项多层次的因子研究， 在25个乳腺外科肿瘤科中交叉了700名新诊断乳腺癌患者的患者层面随机对照试验 评估共享决策参与系统（Shades）以支持PCC的实践。该系统连接一个 情感支持-研究小组先前开发的面向患者的iCanDecide增强版 决策工具，临床医生仪表板的临床水平试验，以帮助临床医生解决剩余的认知和 患者的情感需求。与联盟NCORP研究基地及其统计数据合作 和Data Core，该试验将：1）评估情感支持增强对iCanDecide的影响 主要和次要结局测量患者对PCC的评价，2）评价临床医生的影响 PCC患者评估仪表板，3）检查患者和临床干预的潜在介质， 和4）对两个干预组成部分进行过程评估， 广泛使用Shades。[The成果将为广泛实施 共享决策参与系统，以改善乳腺癌患者的沟通。