Material Hardship as a Targetable Measure of Poverty in Pediatric Cancer

物质困难作为小儿癌症贫困的有针对性的衡量标准

• 批准号: 9756151
• 负责人: Kira O. Bona
• 金额: $ 13.35万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-20 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9756151
• 关键词: 6-Mercaptopurine; Accident and Emergency department; Achievement; Acute Lymphocytic Leukemia; Address; Adherence; Admission activity; Affect; Area; Biological; Cancer Family; Career Mobility; Caring; Child; Child Health; Child health care; Childhood; Childhood Acute Lymphocytic Leukemia; Childhood Leukemia; Clinical Data; Clinical Trials; Cohort Studies; Collaborations; Communicable Diseases; Dana-Farber Cancer Institute; Data; Development; Diagnosis; Dimensions; Disease; Disease Outcome; Disease remission; Dose; Elements; Emergency department visit; Enrollment; Environment; Family; Focus Groups; Food; Funding; Future; Goals; Government; Health; Health Services Accessibility; Health Status; Hospitalization; Household; Housing; Inferior; Infrastructure; Intervention; Intervention Trial; Interview; Investigation; Leukemia Acute Lymphoblastic Chemotherapy; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Mentors; Mentorship; Methods; Modeling; Modification; Morbidity - disease rate; Multi-Institutional Clinical Trial; Newly Diagnosed; Oral; Outcome; Outcomes Research; Palliative Care; Parents; Pathway interactions; Patterns of Care; Pediatric Oncologist; Pediatric Oncology; Pediatrics; Phase; Physicians; Positioning Attribute; Poverty; Protocols documentation; Provider; Qualitative Research; Randomized Clinical Trials; Relapse; Reporting; Research; Research Infrastructure; Research Personnel; Residual state; Resources; Risk; Risk stratification; Series; Standardization; Stratification; Surveys; Therapeutic; Therapeutic Trials; Time; Toxicity due to chemotherapy; Training; United States; Work; base; cancer care; care delivery; career; career development; chemotherapy; childhood cancer mortality; cohort; design; experience; follow-up; health care delivery; health disparity; improved; improved outcome; leukemia; monitoring device; mortality; multidisciplinary; oncology; outcome prediction; pediatric health outcomes; prospective; psychosocial; research and development; screening; social; social health determinants; standardize measure; standardized care; therapy design; therapy development; trial design

PROJECT SUMMARY The objective of the proposed study is to reduce residual morbidity and mortality in pediatric cancer by laying the groundwork for the design of interventions targeting social determinants of health outcomes, specifically poverty. Sequential clinical trials have resulted in steady improvements in survival for children with acute lymphoblastic leukemia (ALL) through incremental advancements in risk stratification and risk-adapted therapy. Despite this achievement, approximately 20% of children with ALL will relapse and 10% will die of their disease making ALL the leading cause of childhood cancer death. One in five children in the United States lives in poverty. Emerging data demonstrate that despite highly standardized care, poverty-related survival disparities exist in childhood ALL in the United States. Mechanisms underlying this relationship have not been defined, nor have targetable domains of poverty been investigated. The hypothesis underlying this proposal is that improved child cancer outcomes are achievable by integrating remediable domains of poverty into risk stratification and developing poverty-targeted interventions. Household material hardship (HMH)—unmet concrete resource needs including food, housing or energy—is a dimension of poverty which predicts general pediatric health outcomes and can be remedied by intervention. Up to 30% of pediatric cancer families report HMH during the first 6 months of chemotherapy; its impact on child cancer outcomes is unknown. A majority of U.S. children diagnosed with acute lymphoblastic leukemia (ALL), the most common childhood cancer, will enroll on a clinical trial. This trial-based paradigm of discovery and care has allowed for steady improvements in biologically-based risk stratification and risk-adapted therapy. Social determinants of health as contributors to outcome have not been systematically incorporated into therapeutic trial design. This proposal leverages an existing clinical trials model of care to investigate the impact of a non-biologic driver of outcome. The specific hypothesis is that HMH impacts pediatric ALL relapse and survival through three mechanisms affecting chemotherapy delivery: (1) Decreased adherence to oral chemotherapy, (2) Inferior underlying child health status leading to chemotherapy toxicity and subsequent delays/dose reductions, and (3) Decreased access to care leading to higher acuity hospital admissions which delay chemotherapy receipt. Building on her pilot work and leveraging the cross-disciplinary expertise of her mentorship team in a mixed methods approach, Dr. Bona proposes to assess whether HMH is associated with inferior disease outcomes in pediatric ALL, and to identify potential mechanisms of action which can be targeted with future interventions. In Aims 1-3) Dr. Bona will embed a prospective survey study of HMH in a phase III multi-center clinical trial for children with newly diagnosed ALL to identify the association between HMH and rates of early relapse and survival (Aim 1), oral chemotherapy adherence (Aim 2a), chemotherapy delivery (Aim 2b) and patterns of care (Aim 3). In Aim 4) Dr. Bona will utilize parent and provider interviews to identify targetable elements in the experience of HMH. Together, these data will inform the subsequent development of an HMH intervention for the clinical trial setting. Poverty crosses all risk group stratifications in pediatric ALL; as such, targeting this predictor of outcomes has the potential to impact a significant proportion of children with cancer. This project will facilitate the candidate's training in three areas central her career development and transition to independence: 1) conduct and design of qualitative research; 2) collaboration on multi-center clinical trials; and 3) understanding the social and biological pathways underlying health inequities. Dr. Bona is pediatric oncologist and outcomes researcher in the richly supportive research setting of the Dana-Farber Cancer Institute (DFCI), an environment ideally suited to the successful conduct of this study. Dr. Bona's research and career development are supported by highly qualified and deeply committed mentors: Dr. Joanne Wolfe, a leader in pediatric palliative care investigation, and Dr. Smita Bhatia a leader in pediatric oncology outcomes research. A dynamic team of advisors with multi-disciplinary expertise in pediatric leukemia, outcomes, disparities, palliative care and psychosocial oncology will oversee the successful conduct of this proposal. Leveraging the research infrastructure of DFCI, the expertise of her mentorship team, and the proposed career development goals Dr. Bona will be well positioned to successfully complete the proposed aims, compete for future R01 funding to support an intervention trial and transition to a career as an independent physician investigator dedicated to reducing health disparities in childhood cancer.

项目总结 建议的研究目的是通过产卵减少儿科癌症的残留发病率和死亡率。 设计针对健康结果的社会决定因素的干预措施的基础，特别是 贫穷。连续的临床试验稳步提高了急性胰腺炎患儿的存活率。 淋巴细胞性白血病(ALL)通过风险分层和风险适应治疗的渐进性进展。 尽管取得了这一成就，约20%的ALL儿童将复发，10%的儿童将死于他们的疾病 使所有儿童癌症死亡的主要原因。在美国，五分之一的儿童生活在 贫穷。新出现的数据表明，尽管医疗高度标准化，但与贫困相关的生存差距 从小就存在于美国。这种关系背后的机制还没有被定义， 也没有对贫困的目标领域进行调查。这一提议背后的假设是 通过将可补救的贫困领域纳入风险中，可以改善儿童癌症的结果 分层和制定针对贫困的干预措施。家庭物质困难(HMH)--未满足 具体的资源需求，包括食物、住房或能源--是贫困的一个方面，预示着 儿童的健康后果，可通过干预措施加以补救。高达30%的儿科癌症家族报告 HMH在化疗的前6个月；它对儿童癌症预后的影响尚不清楚。 大多数美国儿童被诊断为急性淋巴细胞白血病(ALL)，这是儿童时期最常见的 癌症，将登记参加临床试验。这种以试验为基础的发现和护理范例允许稳定地 改进基于生物的风险分层和风险适应治疗。健康的社会决定因素 作为结果的贡献者，尚未系统地将其纳入治疗试验设计。这 一项提案利用现有的临床试验护理模型来调查非生物驱动因素对 结果。具体的假设是，HMH通过三个途径影响儿童的所有复发和存活率 影响化疗效果的机制：(1)口服化疗依从性降低；(2)较差 潜在的儿童健康状况导致化疗毒性和随后的延迟/剂量减少，以及(3) 获得护理的机会减少，导致更高的住院敏锐度，从而推迟了化疗的接受。 以她的试点工作为基础，并利用她的指导团队的跨学科专业知识 方法：博纳博士建议评估HMH是否与较差的疾病结局有关 儿科ALL，并确定未来干预措施可以针对的潜在行动机制。在……里面 AIMS 1-3)博纳博士将在HMH的III期多中心临床试验中嵌入对HMH的前瞻性调查研究 新诊断的ALL儿童确定HMH与早期复发率和 生存(目标1)、口服化疗依从性(目标2a)、化疗给药(目标2b)和护理模式 (目标3)。在目标4)中，博纳博士将利用家长和提供者的访谈来确定 HMH经验。这些数据加在一起，将为随后制定HMH干预措施提供信息 临床试验环境。在儿科ALL中，贫困贯穿所有风险组分层；因此，针对以下目标 预后预测指标有可能影响相当大比例的癌症儿童。 该项目将促进应聘者在以下三个方面的培训：职业发展和过渡 独立性：1)定性研究的实施和设计；2)多中心临床试验的协作； 以及3)了解健康不平等背后的社会和生物途径。博纳医生是儿科医生 Dana-Farber癌症研究环境中的肿瘤学家和结果研究人员 研究所(DFCI)，一个非常适合成功进行这项研究的环境。博纳博士的研究和 职业发展得到了高素质和坚定承诺的导师的支持：Joanne Wolfe博士，一位 儿科姑息治疗研究的领导者，以及儿科肿瘤学结果的领导者Smita Bhatia医生 研究。一支充满活力的顾问团队，在儿童白血病、预后、 差异、姑息治疗和心理社会肿瘤学将监督这项提议的成功实施。 利用DFCI的研究基础设施，她的指导团队的专业知识，以及拟议的职业生涯 发展目标博纳博士将处于有利地位，成功完成提出的目标，争取 未来R01的资金支持干预试验和向独立医生职业的过渡 致力于减少儿童癌症健康差距的研究人员。