Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.
Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.
复制标题
晚期癌症家庭护理人员的决策支持培训：CASCADE 析因试验的研究方案。
DOI：
10.1016/j.cct.2023.107259
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发表时间：
2023
影响因子：
2.2
通讯作者：
Bak
中科院分区：
文献类型：
--
作者：
Gazaway,Shena;Wells,RachelD;Azuero,Andres;Pisu,Maria;Guastaferro,Kate;Rini,Christine;Taylor,Richard;Reed,RhiannonD;Harrell,ErinR;Bechthold,AveryC;Bratches,ReedW;McKie,Peg;Lowers,Jane;Williams,GrantR;Rosenberg,AbbyR;Bak
背景晚期癌症患者在诊断后面临众多决定，并且经常得到家庭护理人员的决策支持。 CASCADE (CAreSupportersCoached to beAdeptDEcision Partners) 析因试验干预旨在培训护理人员技能，为患者提供有效的决策支持并确定最有效的干预措施。方法这是一项 2 中心、单盲、24 因子试验，旨在测试 CASCADE 决策支持培训干预的组成部分，该干预措施针对新诊断的晚期癌症患者的家庭护理人员，由经过专门培训的远程医疗、姑息治疗非专业教练提供。 24 周。家庭看护者（目标 N = 352）被随机分配到 16 种组合中的一种，每组有四个组成部分，每个组成部分有两个级别：1) 关于有效决策合作原则的心理教育（1 次与 3 次课程）； 2) 决策支持沟通培训（1 次 vs 没有）； 3) 渥太华决策指南培训（1 次课程与无课程）和 4) 每月跟进（1 次电话与 24 周的电话）。主要结果是患者报告的 24 周时的决策冲突。次要结局包括患者痛苦、医疗保健利用率、护理人员痛苦和生活质量。将探讨干预组成部分和结果之间的中介因素和调节因素（例如社会人口统计学、决策自我效能、社会支持）。结果将用于构建 CASCADE 的两个版本：一个仅包含有效组件 (d ≥ 0.30)，另一个针对可扩展性和成本进行了优化。讨论该协议描述了第一个析因试验，以多阶段优化策略为基础，对晚期癌症家庭护理人员进行姑息治疗决策支持干预，并将满足该领域识别支持严重疾病决策的有效组件的需求。试验注册：NCT04803604
BackgroundPatients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAreSupportersCoached to beAdeptDEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components.MethodsThis is a 2-site, single-blind, 24factorial 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 (targetN= 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.DiscussionThis 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.Trial registration:NCT04803604