Using music and stories to help kids and parents during leukemia treatment
Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents
NA · Indiana University · NCT04400071
This study tests if using music and audio stories can help reduce stress and improve health for young kids with leukemia and their parents during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 4 sites (Oakland, California and 3 other locations) |
| Trial ID | NCT04400071 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Active Music Engagement (AME) and audio storybooks on young children with Acute Lymphoblastic Leukemia (ALL) and their parents. It aims to understand how these interventions can lower stress levels and improve immune function by measuring biomarkers such as cortisol. The study involves a randomized controlled design with two groups to assess the biological mechanisms and dose-response relationships of AME during the consolidation phase of treatment. By focusing on both emotional and biological outcomes, the research seeks to provide a comprehensive understanding of the benefits of music therapy in pediatric cancer care.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 8 years diagnosed with standard or high-risk B- or T-cell acute lymphoblastic leukemia currently receiving induction therapy, along with a parent who can attend sessions.
Not a fit: Patients with Ph+ ALL, significant cognitive impairments, or those whose parents do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce stress and improve health outcomes for children undergoing leukemia treatment and their parents.
How similar studies have performed: Previous studies have shown promising results with music therapy in improving psychosocial outcomes, but this study uniquely focuses on biological mechanisms, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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).
Where this trial is running
Oakland, California and 3 other locations
- UCSF Benioff Children's Hospital — Oakland, California, United States (RECRUITING)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
- Riley Hospital for Children — Indianapolis, Indiana, United States (RECRUITING)
- Children's Mercy Hospital — Kansas City, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Sheri L Robb, PhD — Indiana University
- Study coordinator: Sheri L Robb, PhD
- Email: shrobb@iu.edu
- Phone: 317-274-3152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Pediatric, Pediatric Cancer