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

项目总结 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。然而，a 大多数音乐治疗研究都集中在使用音乐来改善心理社会维度 健康，不考虑生物层面。此外，很少有研究考察剂量反应。 两性关系。癌症治疗是一种与生俱来的压力经历，相当数量的年轻人 儿童和父母(照顾者)经历着持续的、相互关联的情绪困扰和糟糕的生活质量。 许多父母还因为孩子被诊断出癌症而经历创伤性应激症状 治疗。我们之前测试过的主动音乐参与(AME)干预使用主动音乐播放来 减少癌症治疗的压力属性，以帮助管理经历的情绪/创伤痛苦 幼儿(3-8岁)和父母，并提高生活质量。最近的一项AME试验正在研究心理社会 负责改变子女/父母结果的行动机制。目前的研究在此基础上进行了扩展 通过检查AME对几个生物标记物的影响来提供对如何 积极的音乐干预有助于减轻癌症相关的压力及其提高免疫功能的潜力。 这两组随机对照试验的目的是检查作用的生物学机制和 急性加重期AME对儿童/父母应激的剂量-反应关系 淋巴细胞白血病(ALL)治疗。具体目标是：1)确定AME是否会降低儿童和 父母皮质醇，2)检查皮质醇作为AME对孩子和父母结果影响的中介，以及3) 研究AME对儿童和家长皮质醇的剂量-反应关系。孩子/父母二元(n=228)将 进行分层(按年龄、地点、所有风险水平)，并随机分成四个区组进行AME或注意力控制。每个人 在所有合并期间，小组将在每周门诊期间接受一次45分钟的疗程(4 周标准风险；8周高风险)。家长将在基线上完成测量，并在最后一个测量之后完成 学习时间。儿童和家长的唾液皮质醇样本将在前4个AME的会前和会后采集 或者注意力控制课程。儿童血液样本将在第一阶段之前从常规抽血中保留 和4(所有参与者)和第8次会议(高危参与者)。将使用线性混合模型来估计 AME对儿童和父母皮质醇的影响。检测儿童和父母皮质醇作为AME影响的中介因子 孩子和父母的结果将在ANCOVA环境中执行，符合适当的调解模型 使用MPlus，然后使用百分位数Bootstrap方法测试间接效应以估计间接效应 效果。将使用图解和非线性重复测量模型来检查剂量-反应 AME与儿童及家长皮质醇的关系这些发现将增加对这一现象的机械理解 主动音乐干预对多个生物标志物的影响和对剂量-反应效应的理解 对以证据为基础的使用音乐改善健康的直接影响。

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.