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

Completed · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia, Pediatric, Pediatric Cancer

In brief

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.

Key facts

Study ID

NCT04400071

Run by

Indiana University

People needed

192

Starts

2020-08-07

Expected to finish

2025-04-11

Last updated by the study team

2025-06-26

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• UCSF Benioff Children's Hospital — Oakland, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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