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.

项目概要/摘要 美国五分之一的癌症儿童生活贫困，这些儿童的心理社会状况较差。 与非贫困癌症儿童相比，即使采用相同的临床试验进行治疗，其生存率也会降低 我们认为造成这些差异的原因有两个：贫困家庭不仅有定向化疗。 未满足的基本需求——量化为家庭物质困难（HMH）——他们还承受着有毒的压力， 转化为父母的焦虑、抑郁、认知差和照顾能力受损，并且可测量 为了解决这些因素，我们首先制定了针对儿童炎症的干预措施。 HMH 或缓冲压力的弹性资源 (PediCARE)。 干预措施以 HMH 为目标，通过集中管理的直接资源提供杂货和交通来 在一项随机可行性研究中，PediCARE 是可行的、高度可接受的，并且 然而，它并没有减轻父母的压力或痛苦。 压力管理复原力（PRISM）干预针对四种“复原力资源”来缓冲压力 一项集中管理、以技能为基础的家长辅导计划，以减轻有毒压力和改善应对方式而闻名。 在一项针对癌症儿童父母的随机对照试验中，PRISM 与提高父母的适应力和目标有关。 然而，这种方法在贫困父母中效果不佳。现在，我们提出了一种新的健康方法。 公平干预 (HEI) 将 PediCARE 和 PRISM 结合起来，以针对未满足的基本需求和护理人员 我们将在因贫困而患有高危神经母细胞瘤的儿童的父母中测试这种 HEI。 这种疾病与儿童生存率显着下降有关，这些父母报告说，儿童生存率高、持续 我们将利用十年一次的机会来缓解心理困扰，从而削弱他们照顾孩子的能力。 有机会将该试验整合到更大的儿童肿瘤学组化学免疫治疗试验 ANBL2131 中， 从而确保广泛的入组、强大的项目基础设施和具有临床意义的结果 N=114。 参加 ANBL2131 的 HMH 暴露儿童将以 1:1 的比例随机接受新的 HEI 或常规护理 具体来说，我们的目标是： (1a) 确定 HEI 在改善方面的功效。 父母焦虑（主要结果）、抑郁、认知功能、复原力和 HMH（次要结果）在 6- (1b) 探索 HEI 对父母炎症生物标志物的影响；(2a) 探索 HEI 对儿童的影响； 对诱导治疗的反应和生存；(2b) 探索 HEI 对儿童炎症生物标志物的影响 我们发现，高等教育机构将改善以家长为中心的结果，并预测- 我们拥有出色的多学科团队。 这项试验有可能缩小以前棘手的问题。 此外，它还将为护理和健康研究提供信息。 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。