School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, AL, USA.
Division of Preventive Medicine, UAB Heersink School of Medicine, Birmingham, AL, USA.
Contemp Clin Trials. 2023 Aug;131:107259. doi: 10.1016/j.cct.2023.107259. Epub 2023 Jun 5.
Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components.
This is a 2-site, single-blind, 2 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost.
This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making.
NCT04803604.
诊断出晚期癌症后，患者会面临诸多决策，且经常会从家属照护者处获得决策支持。CASCADE（CAre Supporters Coached to be Adept DEcision partners）综合干预试验旨在培训照护者相关技能，以向患者提供有效的决策支持，并确定最有效的干预内容。
这是一项在 2 个地点开展的、单盲的、2 因素试验，旨在测试针对新诊断的晚期癌症患者家属照护者的 CASCADE 决策支持培训干预的组成部分，该试验由经过专门培训的远程医疗姑息治疗一线教练在 24 周内提供。家属照护者（目标 N=352）被随机分配到四个组件的 16 种组合中的一种，每个组件有两个水平：1）关于有效决策伙伴原则的心理教育（1 次与 3 次）；2）决策支持沟通培训（1 次与无）；3）渥太华决策指南培训（1 次与无）；4）每月随访（1 次电话与 24 周的电话）。主要结局是 24 周时患者报告的决策冲突。次要结局包括患者痛苦、医疗保健利用、照护者痛苦和生活质量。干预内容与结局之间的调节因素和中介因素（例如，社会人口统计学、决策自我效能感、社会支持）将进行探索。结果将用于构建两个版本的 CASCADE：一个仅包含有效内容（d≥0.30），另一个则优化可扩展性和成本。
本方案描述了首个姑息治疗决策支持干预试验，该试验以多阶段优化策略为依据，针对晚期癌症患者家属，这将满足该领域确定支持严重疾病决策的有效内容的需求。
NCT04803604。
