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.

项目总结/摘要 五分之一的美国癌症儿童生活在贫困中。这些孩子的心理社会结果较差， 与非贫困癌症儿童相比，即使接受相同的临床试验治疗， 定向化疗我们认为，这些差异的原因有两个：贫困家庭不仅有 未得到满足的基本需求-被量化为家庭物质困难-他们还经历有害的压力， 转化为焦虑，抑郁，认知能力差，父母的学习能力受损， 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 HMH或缓冲压力的弹性资源。儿科癌症资源公平（PediCARE） 通过中央管理的食品杂货和运输的直接资源供应， 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， 与改善基本需求相关。然而，这并没有减轻父母的压力或痛苦。的促进 压力管理中的复原力（PRISM）干预针对四种“复原力资源”来缓冲压力， 这是一个集中管理的、以技能为基础的父母辅导计划，已知可以减轻有毒压力，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与父母韧性和目标的增加有关。 导向行为。然而，它在贫困的父母中效果不太好。现在，我们提出一种新的健康 将联合收割机PediCARE和PRISM结合起来的公平干预（HEI），以满足未满足的基本需求和照顾者 resilience.我们将在高危神经母细胞瘤患儿的父母中测试这种HEI， 在这种疾病中，与显著降低的儿童存活率相关，这些父母报告说， 心理困扰，损害了他们照顾孩子的能力。我们将利用十年一遇的 有机会将这项试验整合到更大的儿童肿瘤组化学免疫治疗试验ANBL 2131中， 从而确保广泛的招募、强大的项目基础设施和临床有意义的结果。N=114 入组ANBL 2131的HMH暴露儿童将以1：1的比例随机接受新型HEI或常规治疗， 治疗开始至诱导结束（6个月）。具体而言，我们的目标是：（1a）确定HEI在改善 父母焦虑（主要结局）、抑郁、认知功能、恢复力和HMH（次要结局）， （1b）探索HEI对母体炎症生物标志物的影响;（2a）探索HEI对儿童炎症生物标志物的影响。 对诱导治疗的反应和存活率;以及（2b）探索HEI对儿童炎症生物标志物的影响 和氧化应激。我们假设，HEI将改善以父母为中心的结果，并预期证明- 它改善儿童结局和父母/儿童生物标志物的概念。我们有杰出的多学科 多年来一起工作的专家团队。这项试验有可能缩小一个以前棘手的 健康差距和改善儿童癌症结果。此外，它将为护理和健康公平研究提供信息， 通过直接解决已知导致成人和儿童癌症结果差异的社会决定因素。