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

晚期癌症家庭护理人员的决策支持培训：CASCADE 析因试验

• 批准号: 10770967
• 负责人: James N. Dionne-Odom
• 金额: $ 20.41万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10770967
• 关键词: Address; Advanced Malignant Neoplasm; Affect; Anxiety; Breast; Cancer Family; Caregivers; Caring; Communication; Comprehensive Cancer Center; Conflict (Psychology); Data; Decision Making; Development; Diagnosis; Distress; Effectiveness; Enrollment; Family; Family Caregiver; Feedback; Foundations; Friends; Future; Goals; Gynecologic; Health; Healthcare; Hospice Care; Individual; Intervention; Intervention Trial; Interview; Knowledge; Location; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Mental Depression; National Alliance for Caregiving; Newly Diagnosed; Oncology; Operative Surgical Procedures; Outcome; Pain; Palliative Care; Parents; Participant; Patient Care; Patients; Persons; Psychosocial Assessment and Care; Quality of life; Randomized; Reporting; Reproducibility; Research; Resources; Sex Behavior; Sexual Health; Social support; Surveys; Symptoms; Testing; Training; Training Support; cancer care; cancer diagnosis; cancer therapy; cancer type; care recipients; caregiving; coping; cost effective; disabling symptom; end of life; experience; follow-up; health care service utilization; improved; innovation; intimate behavior; malignant breast neoplasm; multiphase optimization strategy; novel; preference; primary endpoint; primary outcome; psychoeducation; psychoeducational; recruit; reproductive; sexual relationship; skills; telehealth; theories

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.

肿瘤学和姑息治疗的首要任务是让 320 万美国家庭护理人员做好准备 癌症有效支持患者从诊断到生命终结的健康相关决策， 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， 包括有关治疗、手术、护理地点、获得姑息治疗等的选择。 如果家庭护理人员没有做好准备，做出这些决定的患者可能会遇到不充分的家庭决定 支持导致哮喘困扰和接受不符合其价值观的护理/治疗，以及 这反过来可能会增加家庭护理人员的痛苦，因此迫切需要对癌症进行培训。 家庭护理人员有效支持患者决策；然而，姑息治疗干预措施很少 经过测试，我们开发了 CASCADE (CAre)，以提高护理人员提供决策支持的技能。 支持者被指导成为熟练的决策合作伙伴），这是一种由非专业导航员主导的远程医疗早期姑息治疗 培训高级癌症护理人员如何有效地与患者合作做出健康决策的干预措施 从我们之前的早期姑息治疗护理干预、决策支持相关的发展而来。 家庭护理人员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以及组件之间的相互作用 影响患者和护理人员的决策结果。 干预措施作为“捆绑”治疗方案，因此很难明确评估哪种干预措施 可以减少、消除或替换组件以提高效率，因此，我们提出了随机化。 23 (2x2x2) 析因试验，这是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、可扩展的版本 352 名新诊断晚期癌症患者的家庭护理人员将被随机分组 接受一项或多项姑息治疗非专业导航员提供的决策合作培训内容，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 比 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 CASCADE 组成部分。 （主要效果/相互作用）对患者和护理人员（包括患者）的结果做出有意义的贡献 医疗保健利用（目标 1）并使用这些结果构建 CASCADE 干预的版本 最大限度地提高有效性和可扩展性（目标 2），为了最大限度地扩大招聘规模，我们将从两个 NCI 指定的人员中进行招聘。 阿拉巴马州伯明翰和佐治亚州亚特兰大的综合癌症中心将使用创新的 MOST 框架。 产生高度新颖且具有成本效益的 CASCADE 版本，用于验证性 RCT 测试、可扩展性、 和再现性。

项目成果

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

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
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 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
• 通讯作者: Bak