Novel Health Equity Intervention to Improve Pediatric Oncology Outcome Disparities: Targeting Poverty and Psychosocial Stress

项目摘要/摘要 五分之一的美国癌症儿童生活在贫困中。这些儿童的心理社会结果较差， 与患有癌症的非贫困儿童相比，即使接受相同的临床试验治疗，生存率也会降低。 定向化疗。我们认为，造成这些差距的原因有两个：贫困家庭不仅拥有 未得到满足的基本需求--量化为家庭物质困难(HMH)--他们还会经历有毒的压力， 转化为父母的焦虑、抑郁、认知不良和照顾能力受损，并可测量 儿童炎症的生物标志物。为了解决这些因素，我们首先开发了有针对性的干预措施 要么是HMH，要么是缓冲压力的弹性资源。儿科癌症资源公平性(儿科) 干预的目标是HMH，通过中央管理的直接资源提供食品杂货和运输到 贫困家庭。在一项随机可行性研究中，PediCARE是可行的、高度可接受的，并且 与改善的基本需求相关联。然而，这并没有减轻父母的压力或痛苦。推介 压力管理中的恢复力(PRISM)干预针对缓冲压力利用的四种“恢复力资源” 这是一个集中管理、以技能为基础的家长辅导计划，可以缓解有毒压力，改善应对能力。 在一项针对癌症儿童父母的随机对照试验中，PRISM与增强的父母韧性和目标-- 有导向的行为。然而，它在贫困父母中的效果就不那么好了。现在，我们提出了一种新的健康 股权干预(HEI)将结合儿科和PRISM，针对未得到满足的基本需求和照顾者 恢复力。我们将在患有高危神经母细胞瘤儿童的父母中测试这种HEI，因为贫困暴露 在这种疾病中，儿童存活率明显较低，这些父母报告的儿童存活率高、持续 心理困扰，削弱他们照顾孩子的能力。我们将利用十年一次的 将这项试验整合到更大的儿童肿瘤学小组化疗免疫治疗试验ANBL2131中的机会， 从而确保广泛的登记、强大的项目基础设施和具有临床意义的结果。N=114 登记在ANBL2131上的接触HMH的儿童将被随机1：1接受新型HEI或常规护理 通过结束诱导开始治疗(6个月)。具体地说，我们的目标是：(1)确定高等学校在改善 父母焦虑(主要结果)、抑郁、认知功能、恢复力和HMH(次要结果) 几个月；(1b)探索高等教育对父母炎症生物标志物的影响；(2a)探索高等教育对儿童的影响 对诱导治疗的反应与存活率；以及(2b)探讨高等教育对儿童炎症生物标记物的影响 和氧化应激。我们假设高等学校将改善以家长为中心的结果，并预期- 改善儿童结局和亲子生物标记物的概念。我们有一个杰出的多学科 在一起工作多年的专家团队。这场审判有可能缩小以前难以解决的 健康差距和改善儿童癌症预后。此外，它还将为医疗保健和健康公平研究提供信息 通过直接解决已知会导致成人和儿童癌症结果差异的社会决定因素。

PROJECT SUMMARY / ABSTRACT One in five U.S. children with cancer lives in poverty. These children have inferior psychosocial outcomes and decreased survival compared to non-poor children with cancer, even when treated with the same clinical trial- directed chemotherapy. We believe the explanation for these disparities is twofold: poor families not only have unmet basic needs—quantified as Household Material Hardship (HMH)—they also experience toxic stress, translating to anxiety, depression, poor cognition, and impaired caregiving abilities among parents, and measurable biomarkers of inflammation among children. To address these factors, we first developed interventions targeting either HMH or the resilience resources that buffer stress. The Pediatric Cancer Resource Equity (PediCARE) intervention targets HMH via centrally-administered direct resource provision of groceries and transportation to poverty-exposed families. In a randomized feasibility study, PediCARE was feasible, highly acceptable, and associated with improved basic needs. However, it did not alleviate parental stress or distress. The Promoting Resilience in Stress Management (PRISM) intervention targets four “resilience resources” to buffer stress utilizing a centrally-administered, skills-based parent-coaching program known to mitigate toxic stress and improve coping. In an RCT of parents of children with cancer, PRISM was associated with increased parent-resilience and goal- oriented behavior. However, it worked less well among poverty-exposed parents. Now, we propose a novel Health Equity Intervention (HEI) that will combine PediCARE and PRISM to target both unmet basic needs and caregiver resilience. We will test this HEI among parents of children with high-risk neuroblastoma because poverty-exposure in this disease is associated with significantly inferior child survival and these parents report high, sustained psychological distress that impairs their ability to care for their child. We will leverage a once-in-a-decade opportunity to integrate this trial into the larger Children’s Oncology Group chemo-immunotherapy trial ANBL2131, thus ensuring wide-spread enrollment, robust project infrastructure, and clinically meaningful outcomes. N=114 HMH-exposed children enrolled on ANBL2131 will be randomized 1:1 to receive the novel HEI or usual care from the start of therapy through end-induction (6-months). Specifically, we aim to: (1a) Identify HEI efficacy in improving parent anxiety (primary outcome), depression, cognitive function, resilience, and HMH (secondary outcomes) at 6- months; (1b) Explore the HEI’s impact on parent biomarkers of inflammation; (2a) Explore the HEI’s impact on child response-to-induction therapy and survival; and (2b) Explore the HEI’s impact on child biomarkers of inflammation and oxidative stress. We hypothesize that the HEI will improve parent-centered outcomes and anticipate proof-of- concept that it improves child outcomes and parent-/child-biomarkers. We have an outstanding multidisciplinary team of experts who have worked together for years. This trial has the potential to narrow a previously intractable health disparity and improve childhood cancer outcomes. Moreover, it will inform care and health equity research by directly addressing social determinants known to drive outcome disparities in both adult and pediatric cancer.