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

项目摘要/摘要 肿瘤学和姑息治疗的一个优先事项是准备320万名美国家庭照顾者 有效支持癌症患者从诊断到生命末期的健康相关决策， 特别是在服务不足的情况下。超过70%的癌症患者让家庭参与健康决策， 包括关于治疗、手术、护理地点、获得姑息治疗等许多方面的选择。 与毫无准备的家庭照顾者一起做出这些决定的患者可能会经历不充分的家庭决定 支持导致更严重的痛苦和接受与其价值观不符的护理/治疗 偏好。这反过来可能会增加家庭照顾者的痛苦。迫切需要对癌症患者进行培训 家庭照顾者有效地支持患者的决策；然而，很少有姑息治疗干预措施 经过测试，以提高护理者提供决策支持的技能。我们已经开发了CARADE(CARE 支持者接受培训，成为熟练的决策伙伴)，一个非专业导航员主导的远程医疗早期姑息护理 培训高级癌症护理人员如何在健康决策中有效地与患者合作的干预措施- 制作。从我们先前的早期姑息护理护理干预演变而来，决策支持相关 为家庭照顾者提供的内容包括有效的社会支持、沟通和渥太华原则 决策指导培训；但是，我们不知道这些组件和组件交互中的哪些组件 影响患者和护理人员的决策结果。传统研究方法治疗 干预措施是“捆绑”的一揽子治疗措施，这使得很难明确评估哪种干预措施 可以减少、取消或更换组件以提高效率。因此，我们提出了一个随机化的 23(2x2x2)析因试验，肿瘤姑息治疗中的第一个此类试验，使用多阶段优化 测试CASCADE组件的策略(MOST)，以便组装优化的、可伸缩的 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到 接受一个或多个姑息关怀层导航员提供的决策合作培训组件，基于 渥太华决策支持框架与社会支持效能理论：1)心理教育 决策支持的社会支持有效性(1次对3次)；2)决策支持沟通培训 (是与否)；以及3)渥太华决策指南培训(是与否)。我们将确定级联组件 (主要影响/相互作用)对患者和护理者(包括患者)的结果有意义的贡献 医疗保健利用率(目标1)，并使用这些结果构建级联干预的版本，即 最大限度地有效和可扩展(目标2)。为了最大限度地扩大招聘，我们将从两个NCI指定的 位于阿拉巴马州伯明翰和佐治亚州亚特兰大的综合性癌症中心。使用创新的MOST框架将 产生用于验证性RCT测试、可伸缩性 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.