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

基本信息

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
项目类别：
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

项目摘要

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/摘要在小儿急性淋巴细胞的早期阶段，体重增加过度会导致肥胖至肥胖很常见白血病（全）治疗，并导致复发的高风险，无事件的生存率较低，并且不利治疗期间的事件。在所有治疗中都缺乏与NCI的优先级相符的，这是减轻体重的长期目标小儿癌症治疗结果的相关差异。干预开发是该提案的目的是适应，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支持堡堡的支持堡在所有治疗的早期阶段，家庭应对压力。儿童，家庭在AIM 1A的治疗过程中起着重要的作用。她的指导团队将适应现有的基于家庭的健康促进间隔（Nourish-T）以满足在所有治疗的早期阶段（nourish-all），青年家庭的特定需求。结合家庭系统和认知行为干预，以支持健康的家庭应对诊断和治疗压力。分娩将通过家庭和年轻人的半结构化意见来告知所有人（至少n = 10）和多学科临床专家（n = 6至少），直到在AIM 1B中达到主题饱和。调查团队将迭代完善与家人的nourish所有干预序列测试所有的年轻人（至少为n = 5）和结构化参与者的反馈将进行。一直持续到达到80％的可行性和可接受性等级，或直到n = 10个家庭完成间隔并提供AIM 2中的结构化反馈在所有治疗的早期阶段，在一次手臂试验中进行试点测试。研究小组将评估参与者参与的关键组成部分，以告知未来，完全动力临床试验，包括招聘率，治疗完成时保留率以及预期的干预剂量通过在所有治疗的早期阶段加入量身定制的健康策略。支撑研究试图改变临床实践范例，以防止与体重相关的治疗差异结果。在所有治疗中，（2）基于家庭行为变化干预措施的科学适应和改进，以及（3）临床的行为集中在行为改变研究和职业发展。在丰富的学术环境中的多学科专家团队的支持下，计划将支持PI的作为癌症控制科学家的过渡到独立性，他拥有适应所需的技能和专业知识基于证据的行为变化干预对小儿癌症的沟渠环境。