Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment

Not Applicable

Recruiting

• Conditions: Acute Lymphoblastic Leukemia, Pediatric; Pediatric Cancer
• Interventions: Behavioral: Active Music Engagement; Behavioral: Audio Storybooks

• Registration Number: NCT04400071
• Lead Sponsor: Indiana University

Brief 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. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and 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: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.

Detailed Description

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. The investigators previously tested an Active Music Engagement (AME) intervention that 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 provide 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=250) 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Study Start: 2020-08-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Child is 3 - 8 years of age at time of enrollment
• Child has diagnosis of standard or high risk B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LyLy)
• Child is currently receiving induction therapy
• One parent (>18 years of age) can be present for all sessions.

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Exclusion Criteria

• Child has Ph+ ALL,
• Child has Cushing disease,
• Child is taking steroid medication for asthma and/or has asthma that is not well controlled,
• The parent does not speak English, or
• The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Music Engagement	Active Music Engagement	See intervention description.
Audio Storybooks	Audio Storybooks	See intervention description.

Primary Outcome Measures

Name	Time	Method
Change in Immunomodulatory Cytokines (children only) (blood)	Pre-Session Week 1 and Week 4 (all child participants); and Pre-Session Week 8 (only high risk child participants).	We will measure serum levels of IL-1β, IL-6, TNF-α, IFN-γ, IL-4, IL-10, and IL-13. The activation of the HPA-axis has been reported to shift to promote the secretion of anti-inflammatory cytokines (IL-4, IL-10, IL-13) and decrease pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IFN-γ) and thus modulate immune function.
Change in Child and Parent Stress (Salivary Cortisol)	Pre/Post-Sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).	We will measure salivary cortisol (a steroid hormone) as a biological indicator of stress. Cortisol is one of the most frequently used biomarkers for stress and has been used in several cancer studies.
Change in Impact of Events Scale - Revised (IES-R)	Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).	A 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions. In our study, parents will respond to items in reference to their child's cancer treatment as the stressor. The scale includes three subscales: intrusion, avoidance, and hyperarousal. Parents respond to each item using a 5-point Likert scale (0 = not at all; 4 = extremely). Higher scores indicate greater traumatic stress symptoms. The IES-R has been used in studies of childhood cancer patients and their parents. Cronbach's alpha for Intrusion, Avoidance, and Hyperarousal scales were .91, .84, and .90 respectively.
Change in Profile of Mood States - Short Form (POMS-SF)	Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).	Measures mood disturbance. The scale is a self-report, 37-item instrument that yields scores on six subscales (tension-anxiety; depression-dejection; anger-hostility; vigor-activity; fatigue-inertia; confusion-bewilderment) and a total mood disturbance score. Respondents are given 37 adjectives used to describe feelings during the last week and asked to respond to each item using a 5-point Likert scale (0 = not at all; 4 = extremely). Higher scores equal greater mood disturbance. Construct validity is widely supported. The POMS-SF strongly correlates with the original 65-item POMS (r = 0.99) and is one of the most commonly used measures for parent emotional distress in pediatric cancer research.
Change in Child Health Questionnaire-Mental Health Subscale (CHQ)	Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)	Measures the frequency of both negative and positive states. Items capture anxiety, depression, and positive affect. We chose the parent-report version due to our targeted child age range of 3-8 years; parent-proxy and child self-report measures are scored differently, so we elected to use parent-proxy for all children. The subscale includes 16 parent-report items on a 5-point Likert-scale, ranging from 1 (none of the time) to 5 (all of the time). Scores range from 16-80 with higher scores indicating better mental health. Across 25 subgroups, the median Cronbach alpha coefficient for the subscale was .76, coefficients ranged from .67 to .86.
Change in Index of Well-being	Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)	A 9-item semantic differential scale describing present life using adjective extremes such as discouraging/hopeful. Higher scores mean greater well-being. The scale has well established construct validity and a reported Cronbach alpha of .93 for the total scale.
Change in KINDLR Questionnaire for Measuring Health-Related Quality of Life in Children	Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).	Measures global quality of life. The KINDL is used widely and has been translated into 11 languages. It was selected over other well-known measures for its positive health perspective, especially for younger children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale, ranging from 1 (never) to 5 (all the time). There are 6 subscales: Physical well-being, Emotional Well-being, Self-Esteem, Family, Friends, and Everyday Functioning. We will use 20 items in 5 subscales, omitting the Everyday Functioning subscale, because it is focused on school-related functioning and children may not be attending school. Scores range from 20 - 100 with higher scores indicating better quality of life. KINDL parent-report is a valid and reliable measure for children as young as age 3. The KINDL has satisfactory convergent and discriminant validity, and a Cronbach alpha of .89 for the total scale.

Trial Locations

Locations (4)

UCSF Benioff Children's Hospital; 🇺🇸 Oakland, California, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States