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: 9355138
• 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/9355138
• 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 Care; 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; Hospitals; Household; Housing; Inferior; 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 disparity; improved; improved outcome; leukemia; monitoring device; mortality; multidisciplinary; oncology; outcome prediction; 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.

项目摘要 拟议的研究的目的是通过放置小儿癌中的残留发病率和死亡率 针对健康结果的社会决定者的干预措施设计的基础，特别是 贫困。顺序临床试验导致急性儿童的存活率稳步提高 淋巴细胞白血病（全部）通过风险分层和适应风险疗法的增量进步。 尽管取得了这一成就，大约有20％的所有患有中继的儿童将死于他们的疾病 使儿童癌症死亡的所有主要原因。美国五分之一的孩子生活在 贫困。新兴数据表明，渴望高标准化的护理，与贫困相关的生存分布 存在于美国的童年。这种关系的基础机制尚未定义， 也没有研究贫困的目标领域。该提议的基础假设是 通过将可补救的贫困领域纳入风险，可以实现改善的儿童癌症结果 分层和发展以贫困为目标的干预措施。家庭材料困难（HMH） - 无需 具体资源需求，包括食物，住房或能源 - 是贫困的维度，可以预测一般 小儿健康结果，可以通过干预来修复。多达30％的小儿癌家庭报告 HMH在化学疗法的前6个月中；它对儿童癌症结果的影响尚不清楚。 大多数美国儿童被诊断出患有急性淋巴细胞白血病（全部），这是最常见的童年 癌症，将参加临床试验。这种基于试验的发现和护理范式允许稳定 基于生物学的风险分层和风险适应疗法的改善。卫生的社会决定者 作为结果的贡献者，尚未系统地纳入治疗试验设计中。这 提案利用现有的临床护理模型来研究非生物驱动因素的影响 结果。具体的假设是HMH通过三个影响小儿中继和生存。 影响化疗递送的机制：（1）依从性降低口服化疗，（2） 基本的儿童健康状况导致化学疗法毒性和随后的延迟/剂量减少，以及（3） 减少获得护理的机会，导致敏锐的医院入院率更高，从而延迟化疗收到。 建立在她的飞行员工作的基础上，并利用她的指导团队的跨学科专业知识 方法方法，Bona博士的提案，以评估HMH是否与下等疾病结局有关 小儿所有人，并确定可以针对未来干预措施的潜在作用机制。在 AIMS 1-3）BONA博士将在III期多中心临床试验中嵌入对HMH的前瞻性调查研究 有新诊断的儿童，以确定HMH和早期救济率之间的关联 生存（AIM 1），口服化学疗法依从性（AIM 2A），化学疗法递送（AIM 2B）和护理模式 （目标3）。在AIM 4）BONA博士将利用父母和提供者的面试来确定在 HMH的经验。这些数据一起将为HMH干预的后续开发提供信息 临床试验设置。贫困跨越小儿所有的风险群体分层；因此，针对这个 结局的预测因子有可能影响大部分癌症儿童。 该项目将促进候选人在三个领域的培训，她的职业发展和过渡 独立：1）定性研究的进行和设计； 2）多中心临床试验的合作； 3）了解健康不平等的社会和生物学途径。博娜博士是儿科 肿瘤学家和成果研究人员在达纳 - 法伯癌的丰富研究环境中 Institute（DFCI），一个非常适合于这项研究成功进行的环境。 Bona博士的研究和 职业发展得到了高度合格和坚定的导师的支持：Joanne Wolfe博士， 小儿姑息治疗投资的负责人，而小儿肿瘤学结果的领导者Smita Bhatia博士 研究。一个充满活力的顾问团队，具有儿科白血病的多学科专业知识，结果， 差异，姑息治疗和社会心理肿瘤学将监督该提议的成功行为。 利用DFCI的研究基础设施，她的心态团队的专业知识以及拟议的职业 开发目标Bona博士将在成功完成拟议的目标，竞争竞争的位置。 未来的R01资金支持干预试验并过渡到职业为独立医生 致力于减少儿童癌症健康差异的研究者。