Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial

项目概要/摘要 肿瘤学和姑息治疗的一个优先事项是让320万美国家庭照顾者做好准备， 有效地支持患者从诊断到生命结束的健康相关决策， 特别是在服务不足的环境中。超过70%的癌症患者让家人参与健康决策， 包括关于治疗、手术、护理地点、获得姑息治疗以及许多其他方面的选择。 在没有准备的家庭照顾者的情况下做出这些决定的患者可能会经历不充分的家庭决定 支持导致更大的痛苦和接受不符合其价值观的护理/治疗， 喜好这反过来又可能增加家庭照顾者的痛苦。迫切需要训练癌症 家庭照顾者有效地支持病人的决策;然而，很少有姑息治疗干预措施 经过测试，以提高护理人员在提供决策支持方面的技能。我们开发了CASCADE（CAre 支持者被训练成为熟练的决策伙伴），一个外行导航员领导的远程医疗早期姑息治疗 干预措施，培训高级癌症护理人员如何有效地与患者合作进行健康决策- 制作。从我们先前的早期姑息治疗干预中发展出来，决策支持相关 家庭照顾者的内容包括有效的社会支持、沟通和渥太华原则 决策指南培训;但是，我们不知道这些组件中的哪些组件和组件交互 影响患者和护理人员的决策结果。传统的研究方法 将干预措施作为“捆绑式”一揽子治疗方案，因此难以明确评估哪些干预措施 可以减少、消除或替换部件以提高效率。因此，我们提出了一个随机的 23（2x2 x2）析因试验，肿瘤姑息治疗中的第一项此类试验，使用多阶段优化 测试CASCADE组件的MOST策略，以组装优化的、可扩展的 干预352名新诊断的晚期癌症患者的家庭照顾者将被随机分配至 接收一个或多个姑息护理外行导航员递送的决策合作培训组件，所述决策合作培训组件基于 渥太华决策支持框架和社会支持有效性理论：1）心理教育 决策支持中的社会支持有效性（1对3次会议）; 2）决策支持沟通培训 (yes 3）渥太华决策指南培训（是与否）。我们将确定CASCADE组件 (main影响/相互作用），对患者和护理人员的结局有意义，包括患者 医疗保健利用率（目标1），并使用这些结果来建立一个版本的级联干预， 最大限度地提高效率和可扩展性（目标2）。为了最大限度地招募，我们将从两个NCI指定的 伯明翰，AL和亚特兰大，GA的综合癌症中心。利用创新的社会变革管理计划框架， 产生高度新颖和成本效益的CASCADE版本，用于验证性RCT测试，可扩展性， 和再现性。

Project Summary/Abstract A priority in oncology and palliative care is preparing the 3.2 million U.S. family caregivers of persons with cancer to effectively support patients in health-related decision-making from diagnosis to the end of life, particularly in underserved settings. Over 70% of patients with cancer involve family in health decisions, including choices about treatments, surgery, location of care, accessing palliative care, and many others. Patients making these decisions with unprepared family caregivers may experience inadequate family decision support leading to heightened distress and receipt of care/treatments inconsistent with their values and preferences. This in turn may increase distress for family caregivers. There is a critical need to train cancer family caregivers to effectively support patient decision-making; however, few palliative care interventions have been tested to enhance caregiver skills in providing decision support. We have developed CASCADE (CAre Supporters Coached to be Adept DEcision partners), a lay navigator-led, telehealth early palliative care intervention to train advanced cancer caregivers how to effectively partner with patients in health decision- making. Evolving out of our prior early palliative care caregiving interventions, decision support relevant content for family caregivers includes principles of effective social support, communication, and Ottawa Decision Guide training; however we do not know which of these components and component interactions influences patient and caregiver decision-making outcomes. Traditional research approaches treat interventions as “bundled” treatment packages, making it difficult to assess definitively which intervention components can be reduced, eliminated, or replaced to improve efficiency. Hence, we propose a randomized 23 (2x2x2) factorial trial, the first such trial in oncology palliative care, using the Multiphase Optimization Strategy (MOST) to test components of CASCADE in order to assemble an optimized, scalable version of the intervention. 352 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more palliative care lay navigator-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on social support effectiveness in decision support (1 vs. 3 sessions); 2) decision support communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no). We will determine CASCADE components (main effects/interactions) that contribute meaningfully to patient and caregiver outcomes, including patient healthcare utilization (Aim 1) and use those results to build a version of the CASCADE intervention that is maximally effective and scalable (Aim 2). To maximize recruitment, we will recruit from two NCI-designated comprehensive cancer centers in Birmingham, AL and Atlanta, GA. Using the innovative MOST framework will yield a highly novel and cost effective version of CASCADE primed for confirmatory RCT testing, scalability, and reproducibility.