A Healthy Weight Intervention for Family Stress during the Early Phases of ALL Treatment: NOURISH-ALL

ALL 治疗早期针对家庭压力的健康体重干预：NOURISH-ALL

• 批准号: 10808650
• 负责人: Carolyn R Bates
• 金额: $ 20.93万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10808650
• 关键词: Acute Lymphocytic Leukemia; Address; Adverse event; Behavior Therapy; Behavioral; Behavioral Model; Cancer Control; Cancer Survivor; Child; Child Health; Childhood Acute Lymphocytic Leukemia; Childhood Cancer Treatment; Chronic; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Conduct Clinical Trials; Coping Skills; Data; Development Plans; Diagnosis; Dietary intake; Disease-Free Survival; Disparity; Dose; Eating; Education; Eligibility Determination; Enrollment; Environment; Family; Feedback; Future; Glucocorticoids; Goals; Health; Health Promotion; Health behavior; Intervention; Interview; Knowledge; Malignant Childhood Neoplasm; Malignant Neoplasms; Mentorship; Modeling; Newly Diagnosed; Obesity; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase; Physical activity; Play; Preparation; Process; Prognosis; Protocols documentation; Research; Research Personnel; Role; Scientist; Sepsis; Shapes; Stress; Stress and Coping; Structure; Survival Rate; System; Targeted Research; Testing; Time; Toxic effect; Training; Treatment Protocols; Treatment outcome; Unhealthy Diet; Weight; Weight Gain; Work; Youth; acceptability and feasibility; arm; behavior change; cancer diagnosis; career; career development; clinical practice; coping; design; efficacy testing; efficacy trial; evidence base; excessive weight gain; experience; family structure; family support; follow-up; healthy weight; high risk; improved; intervention refinement; leukemia treatment; multidisciplinary; patient engagement; patient oriented; physical inactivity; pilot test; prevent; preventive intervention; recruit; relapse risk; research and development; retention rate; sedentary; skill acquisition; skills; stress management; stressor; survivorship; therapy development; treatment disparity; weight gain prevention

PROJECT SUMMARY/ABSTRACT Excessive weight gain leading to obesity is common during the early phases of pediatric acute lymphoblastic leukemia (ALL) treatment, and results in higher risk of relapse, lower event-free survival rates, and more adverse events during treatment. Yet, effective preventive interventions for excessive weight gain during the early phases of ALL treatment are lacking. Aligned with NCI priorities, the long-term objective of this work is to mitigate weight- related disparities in pediatric cancer treatment outcomes. Guided by the ORBIT Model of Behavioral Intervention Development, the goal of this proposal is to adapt, refine, and pilot test a family-based health promotion intervention that aims to curb excessive weight gain among youth with ALL by integrating support for family coping with stress during the early phases of ALL treatment. Given that ALL is most prevalent in young children, families play an essential role in shaping youth’s health behaviors during treatment. In Aim 1a, the PI and her mentorship team will adapt an existing family-based health promotion intervention (NOURISH-T) to meet the specific needs of families of youth in the early phases of ALL treatment (NOURISH-ALL). Adaptations will incorporate family systems and cognitive behavioral intervention components to support healthy family coping with diagnosis and treatment stress. Additional, patient-centered adaptations regarding intervention content and delivery will be informed by semi-structured input from families and youth with ALL (n=10 at minimum) and multidisciplinary clinical experts (n=6 at minimum) until thematic saturation is reached. In Aim 1b, the investigative team will iteratively refine the NOURISH-ALL intervention through sequential testing with families and youth with ALL (n=5 at minimum) and structured participant feedback. Intervention refinement will be ongoing until >80% feasibility and acceptability ratings are achieved or until n=10 families complete the intervention and provide structured feedback. In Aim 2, the adapted and refined NOURISH-ALL intervention will be pilot tested in a single arm trial with 20 newly recruited families of youth in the early phases of ALL treatment. The research team will assess key components of participant engagement to inform the future, fully powered clinical trial, including recruitment rate, retention at treatment completion, and intended intervention dose received. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment outcomes. This K08 will provide opportunities for the PI to acquire skills and knowledge in: (1) the early phases of ALL treatment, (2) scientific adaptation and refinement of family-based behavior change interventions, and (3) the conduct of clinical trials focused on behavior change interventions. The research and career development plan, supported by a multidisciplinary team of experts in a rich academic environment, will support the PI’s transition to independence as a cancer control scientist who possesses the skills and expertise needed to adapt evidence-based behavior change interventions to the pediatric cancer treatment context.

项目摘要/摘要 过度体重增加导致肥胖在儿童急性淋巴母细胞瘤的早期是常见的 白血病(ALL)治疗，并导致更高的复发风险，更低的无事件生存率和更多的不良反应 治疗过程中发生的事件。然而，在早期阶段对过度增加的体重进行有效的预防干预 所有的治疗都是缺乏的。与NCI的优先事项保持一致，这项工作的长期目标是减轻体重- 儿童癌症治疗结果的相关差异。以行为轨道模型为指导 干预发展，本提案的目标是适应、完善和试点测试基于家庭的健康 促进干预措施，旨在通过整合对以下方面的支持来遏制青年与所有人的体重过度增加 在所有治疗的早期阶段，家庭应对压力。鉴于ALL在年轻人中最普遍 儿童、家庭在塑造青少年治疗期间的健康行为方面起着至关重要的作用。在目标1a中，PI 她的指导团队将调整现有的以家庭为基础的健康促进干预措施(Nutiish-T)，以满足 青年家庭在所有治疗的早期阶段的具体需求(滋养所有人)。改编将会 结合家庭系统和认知行为干预组件，支持健康的家庭应对 有诊断和治疗压力。关于干预内容和以患者为中心的其他适应 将由家庭和青年以半结构化的方式提供信息，包括ALL(最少10人)和 多学科临床专家(n=6)，直到达到主题饱和。在目标1b中， 调查小组将通过对家庭进行顺序测试，反复完善滋养所有干预措施 青年和ALL(最少5人)和有组织的参与者反馈。干预细化将是 一直持续到达到80%的可行性和可接受性评级或直到n=10个家庭完成 进行干预，并提供结构化反馈。在目标2中，适应和精炼的滋补-一切干预将 在所有治疗的早期阶段，在20个新招募的青年家庭中进行试点试验。 研究团队将评估参与者参与度的关键组成部分，以全面了解未来 临床试验，包括招募比率、治疗完成时的保留率和预期干预剂量 收到了。通过在所有治疗的早期阶段纳入有针对性的健康促进战略， 拟议的研究试图改变临床实践模式，以防止治疗中与体重相关的差异 结果。K08将为PI提供获得以下技能和知识的机会：(1)早期阶段 在所有治疗中，(2)以家庭为基础的行为改变干预措施的科学适应和改进，以及(3) 临床试验的重点是行为改变干预。研究和职业发展 该计划由一个多学科专家小组在丰富的学术环境中提供支持，将支持国际和平研究所 作为一名拥有适应所需技能和专业知识的癌症控制科学家过渡到独立 儿童癌症治疗背景下的循证行为改变干预。