Healthy Kids after Cancer: A Physical Activity and Nutrition Intervention

描述（由申请人提供）：急性淋巴细胞白血病（ALL）是最常见的儿童癌症，占所有儿童恶性肿瘤的25%。儿童ALL的治疗成功率很高，长期无事件生存率> 85%。然而，治疗的成功并非没有代价。人们越来越认识到与儿童癌症治疗有关的长期健康问题。在治疗期间和治疗后，接受ALL治疗的儿童都有疲劳、体力活动减少、饮食摄入不足和体重过度增加的风险， 其由生理（化疗诱导的）变化和社会（家庭/环境）因素驱动。具体而言，化疗相关的炎症和氧化应激导致疲劳和体重增加，这是由低水平的体力活动，不良的饮食摄入和家庭环境因素维持的。很少有随机对照试验旨在最大限度地减少癌症治疗对ALL后儿童体重，饮食和活动水平的负面影响。以前的研究主要是以中心为基础的干预措施，这对家庭来说很耗时，而且很难在各机构之间以标准化的方式复制，导致出勤率和完成率很低，样本量很小。此外，大多数干预研究没有将体育活动与营养指导相结合，很少有研究关注幼儿。这项试点研究的目的是评估家长为目标的可行性，可接受性和潜在的有效性，电话传递的营养和体力活动计划，以防止不健康的体重增加60儿童ALL幸存者，3-10岁。与以前在儿童癌症幸存者中进行的生活方式干预研究不同，我们的方法直接让父母改变与体力活动和饮食摄入相关的家庭环境因素，以减少疲劳，破坏炎症和氧化应激的循环，并防止化疗后不健康的体重增加。这项试点研究中的干预成功将通过6个月试验中关键体重相关行为（体力活动和饮食摄入量）的变化来衡量，并将检查干预对炎症和氧化应激，疲劳和身体成分生物标志物的初始影响。还将探讨依从性、可接受性和有效性的潜在调节者的作用（即，父母压力，感知儿童脆弱性）。这项研究的结果将用于更广泛的资助申请，以评估这种干预措施在大规模多地点试验中的疗效。作为第一步，拟议的研究将提供重要的科学和实用信息，涉及提供这种干预的可行性，这些计划对儿童癌症幸存者父母的吸引力，以及干预对促进健康饮食摄入，身体活动模式和健康体重，减少疲劳，以及改善完成ALL化疗的儿童的炎症和氧化应激生物标志物。

DESCRIPTION (provided by applicant): Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. Specifically, chemotherapy-related inflammation and oxidative stress contribute to fatigue and weight gain, which are sustained by low levels of physical activity, poor dietary intake, and home environmental factors. Very few randomized controlled trials have been directed towards minimizing the negative impact of cancer treatment on body weight, diet, and activity levels in children after ALL. Previous studies have been predominantly center- based interventions, which are time consuming for families and difficult to replicate in standardized fashion across institutions, resulting in poor attendance and completion rates and small sample sizes. Moreover, most intervention studies have not paired physical activity with nutrition guidance and few have focused on young children. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 3-10 years of age. Unlike previous lifestyle-intervention studies among pediatric cancer survivors, our approach directly engages parents to modify home environmental factors related to physical activity and dietary intake to reduce fatigue, disrupt th cycle of inflammation and oxidative stress, and prevent unhealthy weight gain after chemotherapy. Intervention success in this pilot study will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6- month trial, and initia impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined. The role of potential moderators of adherence, acceptability, and efficacy will also be explored (i.e., parenting stress, perceived child vulnerability). Findings frm this study will be used to inform a broader grant application to evaluate the efficacy of this intervention in a large-scale, multisite trial. As a first step, the proposed study would provide important scientific and practical information regarding the feasibility of delivering this intervention, the attractiveness of such programs to parents of childhood cancer survivors, and the potential effectiveness of the intervention for promoting healthy dietary intake, physical activity patterns and healthy weight, reducing fatigue, and improving biomarkers of inflammation and oxidative stress in children who have completed chemotherapy for ALL.