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Physical Activity to Modify Sequelae and QOL in Childhood ALL: A Nursing Trial

改善儿童期后遗症和生活质量的体力活动 ALL：一项护理试验

基本信息

批准号：
8472450
负责人：
CHERYL Lorane COX
金额：
$ 69.4万
依托单位：
ST. JUDE CHILDREN'S RESEARCH HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-12 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8472450
关键词：
Acute Lymphocytic Leukemia Affect Aftercare Age Articular Range of Motion Bone Density Bone Mineral Contents Bone necrosis Cardiovascular Diseases Cardiovascular system Child Child health care Childhood Acute Lymphocytic Leukemia Chronic Disease Clinical Trials Diabetes Mellitus Diagnosis Discipline of Nursing Disease Dual-Energy X-Ray Absorptiometry Energy Metabolism Face Family Fatigue Future Gender Health Income Intervention Knowledge Late Effects Left Life Long-Term Effects Malignant Childhood Neoplasm Measures Mediating Medical Motivation Motor Motor Skills Movement Muscle Myopathy Newly Diagnosed Obesity Osteoporosis Outcome Parenting Education Parents Patient Self-Report Patients Peripheral Nervous System Diseases Physical Function Physical activity Placebos Quality of life Questionnaires Randomized Risk Scanning Survival Rate Survivors Testing United States Walking abstracting base behavior change cancer therapy chemotherapy clinical practice design efficacy testing experience fitness health related quality of life improved multi-site trial multidisciplinary muscle strength premature prevent programs protective behavior response standard care treatment as usual treatment duration

项目摘要

Abstract The cure rate for acute lymphoblastic leukemia (ALL) currently exceeds 80%, leaving young survivors with 60+ potential years of life. However, these young patients face major hurdles: 1) initial responses to the disease and to treatment include peripheral neuropathy; myopathy; decreased strength, range of motion, and gross and fine motor function; reduced energy expenditure, fitness, bone mineral content, and bone density; and decreased health-related quality of life (HRQL); 2) long-term effects of therapy include persistent fatigue; decreased physical function/fitness; decreased HRQL; obesity; and significant risk of premature chronic illnesses (e.g., diabetes, osteonecrosis, osteoporosis, cardiovascular disease). Patients' muscle strength, endurance, bone density, and HRQL have been improved by short-term physical activity interventions initiated late in treatment, after function has diminished. We propose to inititate an intervention 7-10 days after medical therapy begins and extend it through 2.5 years of treatment. This will be the first such multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 5-18.99 years) with newly diagnosed ALL and will test the ability of the intervention to prevent or diminish early physical function limitations and improve HRQL. Secondary aims will evaluate the mediating effects of motivation and affect and the moderating effects of gender, age, income, and parent education. Through 3 post-baseline assessments 8 weeks, 15 weeks, and 135 weeks after the start of chemotherapy, the intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (135 weeks only); and 2) HRQL. This multi-site trial will test the intervention in 208 children with ALL (104 receiving the intervention and 104 receiving a placebo "minimal movement" standard care strategy). The knowledge generated by this study has the potential to 1) immediately improve current clinical practices for children with ALL, thereby easing their transition through therapy; 2) provide an effective strategy, based in motivation, that will support life-long behavior changes to minimize late effects of ALL therapy; and 3) extend the intervention to other childhood cancers and to other health risk and health protective behaviors that have the potential to modify late effects of childhood cancer therapy.

摘要急性淋巴细胞白血病（ALL）的治愈率目前超过80%，潜在的寿命。然而，这些年轻患者面临着主要障碍：1）对疾病的初步反应和治疗包括周围神经病变;肌病;减少的力量，活动范围，和精细运动功能;降低的能量消耗、健身、骨矿物质含量和骨密度;以及降低健康相关的生活质量（HRQL）; 2）治疗的长期影响包括持续疲劳; 身体功能/健康下降; HRQL下降;肥胖;以及过早慢性疾病（例如，糖尿病、骨坏死、骨质疏松症、心血管疾病）。患者的肌肉力量，耐力、骨密度和HRQL已通过开始的短期体力活动干预得到改善在治疗后期，在功能减弱之后。我们建议在医疗后7-10天开始干预治疗开始并延长至2.5年的治疗期。这将是第一个这样的多学科，一项针对儿童量身定制的、以父母和儿童为中心的体育活动计划的随机纵向试验 (ages 5-18.99岁），并将测试干预措施预防或减少早期身体功能限制，改善HRQL。次要目标将评估中介动机和情感的影响和性别，年龄，收入和父母教育的调节作用。通过化疗开始后8周、15周和135周的3次基线后评估，将测试干预对以下方面的影响：1）身体功能结果（肌肉力量，运动范围，耐力、粗大运动技能）、骨密度和骨矿物质含量（仅135周）;和2）HRQL。这一项多中心试验将在208名ALL儿童中测试干预措施（104名接受干预措施，104名接受治疗）。接受安慰剂“最小运动”标准护理策略）。这项研究所产生的知识潜在的1）立即改善目前对ALL儿童的临床实践，从而缓解他们的通过治疗过渡; 2）提供有效的策略，基于动机，将支持终身行为改变，以最大限度地减少ALL治疗的后期影响; 3）将干预扩展到其他儿童癌症和其他健康风险和健康保护行为，这些行为有可能改变癌症的晚期效应。儿童癌症治疗。