NCT04400071Completed
Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment
Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 192 (actual)
- First submitted
- 15 May 2020
- Start date
- 7 Aug 2020
- Primary completion date
- 11 Apr 2025
- Lead sponsor
- Indiana University
- NCT number
- NCT04400071
What you commit to
- Study type: Interventional
- Participants enrolled: 192
- From 7 Aug 2020 to the primary completion date, 11 Apr 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child is taking steroid medication for asthma and/or has asthma that is not well controlled,
Other illness
- Child has Cushing disease,
- The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents).
Other
- Child has Ph+ ALL,
- The parent does not speak English, or
Who the study is looking for
- 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.
Age in the registry: 3 years to 8 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UCSF Benioff Children s Hospital Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.