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优先事项是为320万美国家庭护理人员准备 从诊断到生命尽头的健康相关决策中有效地支持患者的癌症， 特别是在服务不足的环境中。超过70％的癌症患者参与家庭决策， 包括有关治疗，手术，护理位置，获得姑息治疗的选择。 用未准备好家庭照料者做出这些决定的患者可能会遇到家庭决定不足 支持导致痛苦加剧，并接受护理/治疗与其价值观不一致的人和 偏好。反过来，这可能会增加家庭护理人员的困扰。迫切需要训练癌症 家庭护理人员有效地支持患者决策；但是，很少有姑息治疗干预措施 我们已经开发了级联（护理） 支持者被指导为熟练的决策伙伴），这是一个由外行导航员主导的，远程医疗的早期姑息治疗 干预以培训高级癌症护理人员如何有效与患者合作健康决策 制作。从我们先前的早期姑息治疗护理干预措施中演变出来，决策支持相关 家庭护理人员的内容包括有效的社会支持，沟通和渥太华的原则 决策指南培训；但是，我们不知道这些组件和组件交互中的哪个 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”的治疗套件，因此很难确定评估哪种干预措施 可以降低，消除或更换组件以提高效率。因此，我们提出了一个随机的 23（2x2x2）阶乘试验，第一个使用多相优化的肿瘤学姑息治疗中的第一个此类试验 策略（大多数）测试级联的组件，以组装优化的可扩展版本 干涉。 352名新诊断晚期癌症患者的家庭护理人员将随机分配给 基于 渥太华的决策框架和社会支持效力理论：1）关于心理教育 在决策支持中的社会支持有效性（1次与3个会议）； 2）决策支持沟通培训 （是的与否）； 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/互动）对患者和护理人员的结果有意义地贡献，包括患者 医疗保健利用（AIM 1）并使用这些结果来构建级联干预的版本 最大有效且可扩展（AIM 2）。为了最大化招聘，我们将从两个NCI指定的 阿拉巴马州伯明翰和佐治亚州亚特兰大的综合癌症中心。使用创新的大多数框架将 产生一个高度新颖且具有成本效益的级联版本，用于确认RCT测试，可伸缩性， 和可重复性。

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