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

改善儿科肿瘤结果差异的新型健康公平干预措施：针对贫困和社会心理压力

• 批准号: 10341663
• 负责人: Kira O. Bona
• 金额: $ 65.14万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10341663
• 关键词: Address; Adult; Anxiety; Biological Markers; Cancer Center; Caregivers; Caring; Child; Child Care; Child Health; Childhood; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Cognition; Combined Modality Therapy; Coping Skills; Diagnosis; Disease; Disease-Free Survival; Distress; Enrollment; Ensure; FDA approved; Family; Family health status; Feasibility Studies; Food; Goals; Hormones; Household; Housing; Immuno-Chemotherapy; Immunotherapy; Impairment; Inferior; Inflammation; Inflammatory; Infrastructure; Intervention; Isoprostanes; Malignant Childhood Neoplasm; Malignant Neoplasms; Manuscripts; Measurable; Medical; Mental Depression; Mental Health; Metabolism; Multi-Institutional Clinical Trial; Neoadjuvant Therapy; Neuroblastoma; Outcome; Oxidative Stress; Parents; Pediatric Oncology; Pediatric Oncology Group; Pilot Projects; Poverty; Preparation; Psychosocial Stress; Randomized; Relapse; Reporting; Research; Research Infrastructure; Resources; Secondary to; Self Efficacy; Serum; Severities; Solid Neoplasm; Source; Standardization; Stress; System; Testing; Training; Translating; Transportation; Treatment Efficacy; Work; base; cancer therapy; caregiving; chemotherapy; cognitive function; coping; cytokine; experience; goal oriented behavior; health disparity; health equity; high risk; immunoregulation; improved; multidisciplinary; neoplasm resource; novel; novel therapeutics; peer; poverty reduction; primary outcome; programs; psychologic; psychological distress; psychosocial; resilience; response; secondary outcome; skills; social determinants; social health determinants; stress management; successful intervention; tool; treatment arm; treatment as usual; treatment response; tumor diagnosis

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.

项目摘要 /摘要 五分之一的美国癌症儿童生活在贫困中。这些孩子的社会心理成果较低， 与非贫困儿童相比，生存率降低，即使接受了相同的临床试验治疗 定向化疗。我们认为对这些发行的解释是双重的：贫穷的家庭不仅有 未满足的基本需求 - 被认为是家庭材料困难（HMH） - 他们也经历有毒压力， 转化为焦虑，抑郁，认知不良和父母之间的护理能力受损 儿童炎症的生物标志物。为了解决这些因素，我们首先制定了针对的干预措施 HMH或缓冲压力的弹性资源。小儿癌症资源平等（PETICARE） 干预措施通过集中管理的杂货提供直接资源和运输来针对HMH 暴露于贫困家庭。在一项随机可行性研究中，PECRARE是可行的，高度可接受的，并且 与改善的基本需求有关。但是，它并没有减轻父母的压力或困扰。晋升 压力管理中的弹性（PRISM）干预措施目标是四个“弹性资源”来缓冲压力利用 一项基于中心的，基于技能的父母教练计划已知，以减轻有毒的压力和改善应对。 在癌症儿童父母的一群中，棱镜与父母释放和目标的增加有关 定向行为。但是，在暴露于贫困的父母中效果不佳。现在，我们提出了一种新颖的健康 股权干预（HEI）将结合学科和棱镜，以针对未满足的基本需求和照料者 弹力。我们将在患有高风险神经母细胞瘤儿童的父母中测试此HEI，因为贫困暴露 在这种疾病中，儿童的生存率显着较低，这些父母报告很高，持续 心理困扰会损害他们照顾孩子的能力。我们将利用一个十年的时间 将该试验纳入较大的儿童肿瘤学组化学免疫疗法试验ANBL2131的机会， 从而确保广泛的入学率，强大的项目基础设施和临床意义的结果。 n = 114 参加ANBL2131的HMH暴露儿童将被随机分配1：1，从 通过最终诱导（6个月）开始治疗的开始。具体而言，我们的目标是：（1A）确定HEI效率在提高 父母动画（主要结果），抑郁症，认知功能，韧性和HMH（次要结果）在6-- 月份； （1B）探索HEI对炎症的父母生物标志物的影响； （2a）探索HEI对孩子的影响 对诱导疗法的反应和生存； （2b）探索HEI对炎症儿童生物标志物的影响 和氧化应激。我们假设HEI将改善以父母为中心的结果，并预期 它可以改善子女的结果和父母/育儿标志物的概念。我们有一个出色的多学科 多年来共同努力的专家团队。该试验有可能缩小先前棘手的范围 健康差异并改善儿童癌症的结果。此外，它将为护理和健康公平研究提供信息 通过直接解决已知的成人和小儿癌症结果差异的社会决定者。