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.
Age range
3 Years – 8 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in Child and Parent Stress (Salivary Cortisol)
Timeframe: Pre/Post-Sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).
Change in Immunomodulatory Cytokines (children only) (blood)
Timeframe: Pre-Session Week 1 and Week 4 (all child participants); and Pre-Session Week 8 (only high risk child participants).
Change in Child Health Questionnaire-Mental Health Subscale (CHQ)
Timeframe: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)
Change in KINDLR Questionnaire for Measuring Health-Related Quality of Life in Children
Timeframe: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
Change in Profile of Mood States - Short Form (POMS-SF)
Timeframe: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
Change in Impact of Events Scale - Revised (IES-R)
Timeframe: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
Change in Index of Well-being
Timeframe: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)