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