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.

项目总结/摘要 在小儿急性淋巴细胞白血病的早期阶段，体重过度增加导致肥胖是常见的。 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， 治疗期间的事件。然而，在早期阶段对体重过度增加的有效预防干预措施 所有的治疗都缺乏。根据NCI的优先事项，这项工作的长期目标是减轻体重- 儿科癌症治疗结果的相关差异。以行为的轨道模型为指导 干预发展，这一建议的目标是适应，完善，并试点测试一个以家庭为基础的健康 促进干预，旨在通过整合对以下方面的支持， 在ALL治疗的早期阶段，家庭应对压力。鉴于ALL在年轻人中最普遍， 在治疗期间，家庭在塑造青少年的健康行为方面发挥着至关重要的作用。在目标1a中，PI 她的导师团队将调整现有的以家庭为基础的健康促进干预（NOURISH-T），以满足 青少年家庭在急性淋巴细胞白血病治疗早期阶段的特殊需求（NOURISH-ALL）。适配将 结合家庭系统和认知行为干预组成部分，以支持健康的家庭应对 诊断和治疗压力。此外，以患者为中心的适应性干预内容， 将通过来自ALL患者家庭和青少年（至少n=10）的半结构化输入来告知交付情况， 多学科临床专家（至少n=6），直到达到专题饱和。在目标1b中， 调查小组将通过对家庭的连续测试，反复完善NOURISH-ALL干预措施 和青少年ALL（n=5至少）和结构化的参与者反馈。干预措施的完善将是 持续进行，直到达到>80%的可行性和可接受性评级，或直到n=10个家庭完成 干预和提供结构化反馈。在目标2中，经过调整和完善的NOURISH-ALL干预措施将 在ALL治疗的早期阶段，在20个新招募的青少年家庭中进行单组试验的初步测试。 研究团队将评估参与者参与的关键组成部分，以告知未来， 临床试验，包括招募率、治疗完成时的保留率和预期干预剂量 收到。通过在ALL治疗的早期阶段纳入量身定制的健康促进策略， 一项拟议的研究旨在改变临床实践模式，以防止治疗中与体重相关的差异 结果。K 08将为PI提供机会，以获得以下方面的技能和知识：（1）早期阶段 （2）科学调整和完善以家庭为基础的行为改变干预措施，以及（3） 开展的临床试验侧重于行为改变干预措施。研究和职业发展 该计划由多学科专家团队在丰富的学术环境中支持，将支持PI的 过渡到独立的癌症控制科学家谁拥有的技能和专业知识，需要适应 基于证据的行为改变干预儿科癌症治疗背景。