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: 10411927
• 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/10411927
• 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 Research; Dimensions; Disease; Distress; Dose; Emotional; Environment; Funding; Glucocorticoids; Health; Hospitals; Hydrocortisone; Individual; Intervention; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Mediating; Mediation; Mediator; Modeling; Music; Music Therapy; National Center for Complementary and Integrative Health; 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; Stressful Event; Symptoms; Target Populations; Testing; Therapeutic Studies; Time; Treatment Failure; Work; attentional control; biobehavior; burden of illness; cancer diagnosis; cancer therapy; care systems; clinical practice; clinical translation; 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; 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.

项目概要 音乐治疗已成为许多儿科和成人医院的标准姑息治疗服务。然而，一个 大多数音乐治疗研究都集中在使用音乐来改善心理方面 健康，而不考虑生物学维度。此外，很少有研究检查剂量反应 关系。癌症治疗本质上是一种充满压力的经历，并且相当多的年轻人 儿童和父母（照顾者）经历持续的、相互关联的情绪困扰和生活质量差。 许多父母也会因为孩子的癌症诊断和治疗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，以帮助管理患者所经历的情绪/创伤性困扰 幼儿（3-8 岁）和父母，提高生活质量。最近的 AME 试验正在检查社会心理 负责改变儿童/家长结果的行动机制。目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提供更全面的了解 积极的音乐干预有助于减轻与癌症相关的压力及其改善免疫功能的潜力。 这两组随机对照试验的目的是检查效应的生物学机制和 急性巩固期 AME 对儿童/父母压力的剂量反应关系 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 对儿童和父母结果影响的中介因素，以及 3) 检查 AME 对儿童和父母皮质醇的剂量反应关系。孩子/父母二人组 (n=228) 将 分层（按年龄、部位、ALL 风险水平）并随机分为 AME 或注意力控制组，每组 4 组。每个 在 ALL 巩固期间（4 周标准风险； 8 周高风险）。家长将在基线和最后一次之后完成措施 学习会。前 4 次 AME 会前和会后将采集儿童和家长唾液皮质醇样本 或注意力控制课程。儿童血液样本将从第 1 次会议之前的常规抽血中保留 第 4 节（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 对儿童和父母皮质醇的影响。检查儿童和父母皮质醇作为 AME 影响的调节因素 儿童和家长的结果将在 ANCOVA 设置中进行，拟合适当的中介模型 使用 MPlus，然后使用百分位引导法测试间接影响来估计间接影响 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 与儿童和父母皮质醇的关系。研究结果将增加对机制的理解 积极的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， 对基于证据的使用音乐来改善健康的直接影响。

项目成果

Implementing NIH Behavior Change Consortium Treatment Fidelity Recommendations in a Multi-Site Randomized Controlled Trial of an Active Music Engagement Intervention for Young Children with Cancer and Parents.

在对患有癌症的幼儿和父母进行积极音乐参与干预的多中心随机对照试验中实施美国国立卫生研究院行为改变联盟的治疗保真度建议。

• 发表时间: 2022
• 影响因子: 2.9
• 作者: MacLean, Jessica A;Stegenga, Kristin A;Henley, Amanda K;Robb, Sheri L
• 通讯作者: Robb, Sheri L