Biologic Mechanisms and Dosing of Active Music Engagement to Manage Acute Treatment Distress and Improve Health Outcomes in Young Children with Acute Lymphoblastic Leukemia and Parents

积极音乐参与管理急性治疗困扰并改善急性淋巴细胞白血病幼儿及其父母健康结果的生物机制和剂量

• 批准号: 10181082
• 负责人: Sheri L Robb
• 金额: $ 39.42万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10181082
• 关键词: Acute; Acute Lymphocytic Leukemia; Address; Adult; Affect; Age; Analysis of Covariance; Area; Behavior; Behavioral; Biological; Biological Markers; Blood; Blood specimen; Caregivers; Child; Childhood; Chronic Disease; Clinic Visits; Clinical; Clinical Research; Dimensions; Disease; Distress; Dose; Emotional; Environment; Funding; Glucocorticoids; Health; Hospitals; Hydrocortisone; Individual; Intervention; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Mediating; Mediation; Mediator of activation protein; Modeling; Music; Music Therapy; Oncology; Outcome; Palliative Care; Parents; Participant; Pediatric Oncology; Phase; Play; Population; Production; Quality of life; Randomized; Randomized Controlled Trials; Relapse; Risk; Salivary; Sampling; Site; Sociology; Stress; Symptoms; Target Populations; Testing; Therapeutic Studies; Time; Treatment Failure; Work; attentional control; biobehavior; burden of illness; cancer diagnosis; cancer therapy; care systems; clinical practice; cytokine; design; emotional distress; evidence base; experience; high risk; hypothalamic-pituitary-adrenal axis; immune function; immunoregulation; improved; interest; leukemia treatment; multidisciplinary; palliative; primary caregiver; psychologic; psychosocial; response; stress symptom; therapy design; translational study; traumatic stress

PROJECT SUMMARY Music therapy has become a standard palliative care service in many pediatric and adult hospitals. However, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. In addition, few studies have examined dose-response relationships. Cancer treatment is an inherently stressful experience, and a significant number of young children and parents (caregivers) experience persistent, interrelated emotional distress and poor quality of life. Many parents also experience traumatic stress symptoms because of their child's cancer diagnosis and treatment. Our previously tested Active Music Engagement (AME) intervention uses active music play to diminish stressful attributes of cancer treatment to help manage emotional/traumatic distress experienced by young children (ages 3-8) and parents and improve quality of life. A recent AME trial is examining psychosocial mechanisms of action responsible for change in child/parent outcomes. The current study expands on this work by examining AME's effects on several biomarkers to povide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: 1) establish whether AME lowers child and parent cortisol, 2) examine cortisol as a mediator of AME effects on child and parent outcomes, and 3) examine the dose-response relationship of AME on child and parent cortisol. Child/parent dyads (n=228) will be stratified (by age, site, ALL risk level) and randomized in blocks of four to AME or attention control. Each group will receive one 45-minute session during weekly clinic visits for the duration of ALL consolidation (4 weeks standard risk; 8 weeks high risk). Parents will complete measures at baseline and following the last study session. Child and parent salivary cortisol samples will be taken pre and post-session for the first 4 AME or attention control sessions. Child blood samples will be reserved from routine blood draws prior to sessions 1 and 4 (all participants) and session 8 (high risk participants). Linear mixed models will be used to estimate AME's effect on child and parent cortisol. Examining child and parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting, fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate the indirect effect. Graphical plots and non-linear repeated measures models will be used to examine the dose-response relationship of AME on child and parent cortisol. Findings will increase mechanistic understanding of the effects of active music interventions on multiple biomarkers and understanding of dose-response effects, with direct implications for the evidence-based use of music to improve health.

项目摘要 音乐疗法已成为许多儿科和成人医院的标准姑息治疗服务。但是， 大多数音乐疗法研究都集中在使用音乐来改善心理心理维度 健康，不考虑生物学维度。此外，很少有研究检查剂量反应 关系。癌症治疗是一种固有的压力经历，大量的年轻人 儿童和父母（照顾者）经历了持久，相互关联的情绪困扰和生活质量差。 由于孩子的癌症诊断和 治疗。我们先前测试过的主动音乐参与（AME）干预使用主动音乐播放 减少癌症治疗的压力属性，以帮助管理经历的情绪/创伤困扰 幼儿（3-8岁）和父母，并改善生活质量。最近的AME试验正在检查社会心理 负责儿童/父母结果变化的行动机制。当前的研究对此进行了扩展 通过检查AME对几种生物标志物的影响来进行工作，以对如何进行更全面的了解 主动音乐干预措施可减轻与癌症相关的压力及其改善免疫功能的潜力。 这两个组，随机对照试验的目的是检查效应的生物学机制和 AME在急性合并阶段对儿童/父胁迫的剂量反应关系 淋巴细胞白血病（全）。具体目的是：1）确定AME是否降低儿童和 父皮质醇，2）将皮质醇作为对儿童和父母结果的影响的介体，3） 检查AME对子女皮质醇的剂量反应关系。儿童/家长二元组（n = 228）将 分层（按年龄，现场，所有风险水平）进行分层，并在四个块中随机分为AME或注意力控制。每个 在所有合并期间，小组将在每周诊所访问期间接受一次45分钟的会议（4个 周标准风险； 8周高风险）。父母将在基线和最后一个措施完成措施 学习课程。儿童和家长唾液皮质醇样品将在前4个AME进行前后。 或注意力控制会议。儿童血液样本将在会议之前从常规的血液中保留。 和4（所有参与者）和第8节（高风险参与者）。线性混合模型将用于估计 AME对子女皮质醇的影响。检查子女皮质醇作为AME影响的介体 儿童和父母的结果将在ANCOVA环境中进行，适合适当的调解模型 使用MPLUS，然后使用百分位自举方法测试间接效应以估计间接效果 影响。图形图和非线性重复测量模型将用于检查剂量反应 AME与子女皮质醇的关系。调查结果将增加对 主动音乐干预对多种生物标志物的影响以及对剂量反应效应的理解 直接对基于循证音乐改善健康的影响。