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

• 批准号: 7656983
• 负责人: CHERYL Lorane COX
• 金额: $ 102.4万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-12 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7656983
• 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; Figs - dietary; 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; base; behavior change; bone; cancer therapy; chemotherapy; clinical practice; density; design; efficacy testing; experience; fitness; health related quality of life; improved; multi-site trial; multidisciplinary; muscle strength; premature; prevent; programs; protective behavior; public health relevance; response; standard care; treatment as usual; treatment duration

DESCRIPTION (provided by applicant): The cure rate for acute lymphoblastic leukemia (ALL) currently exceeds 80 percent, 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. Public Health Relevance: During chemotherapy, children with acute lymphoblastic leukemia experience decreased strength, range of motion, energy, bone mineral density (BMD)/bone mineral content (BMC), and reduced quality of life. This application will test a motivation-based physical activity intervention targeting patients and their families, begun within 10 days after therapy begins, that has the potential to: prevent or diminish these early physical limitations, maintain or increase BMD/BMC, and improve quality of life for these young patients.

描述（由申请人提供）：急性淋巴细胞白血病（ALL）的治愈率目前超过80%，使年轻的幸存者拥有60年以上的潜在寿命。然而，这些年轻患者面临着主要障碍：1)对疾病和治疗的初始反应包括周围神经病变；肌病;力量、活动范围、粗大和精细运动功能下降；降低能量消耗、体能、骨矿物质含量和骨密度；健康相关生活质量（HRQL）下降；2)治疗的长期影响包括持续性疲劳；身体机能/健康下降；HRQL下降;肥胖;过早罹患慢性疾病（如糖尿病、骨坏死、骨质疏松症、心血管疾病）的风险显著。患者的肌肉力量、耐力、骨密度和HRQL在功能减退后，通过治疗后期开始的短期身体活动干预得到改善。我们建议在药物治疗开始后7-10天开始干预，并延长至2.5年的治疗。这将是首个针对新诊断为ALL的儿童（5-18.99岁）量身定制的、以家长和儿童为中心的体育活动计划的多学科、随机、纵向试验，并将测试干预预防或减少早期身体功能限制和改善HRQL的能力。次要目的将评估动机和情感的中介作用，以及性别、年龄、收入和父母教育程度的调节作用。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，活动范围，耐力，大运动技能），骨密度和骨矿物质含量（仅135周）；2) HRQL。这项多地点试验将在208名ALL儿童中测试干预措施（104名接受干预，104名接受安慰剂“最小运动”标准护理策略）。这项研究产生的知识有潜力：(1)立即改善目前ALL儿童的临床实践，从而缓解他们通过治疗的过渡；2)提供基于动机的有效策略，支持终生行为改变，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以及其他有可能改变儿童癌症治疗后期效果的健康风险和健康保护行为。公共卫生相关性：在化疗期间，急性淋巴细胞白血病儿童的力量、活动范围、能量、骨矿物质密度(BMD)/骨矿物质含量（BMC）下降，生活质量下降。该应用程序将测试一种基于动机的身体活动干预，目标是患者及其家人，在治疗开始后10天内开始，这有可能：预防或减少这些早期身体限制，维持或增加BMD/BMC，并改善这些年轻患者的生活质量。