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Music Therapy for Pediatric Cancer

N/A
Recruiting
Led By Sheri L Robb, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child has diagnosis of standard or high risk B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LyLy)
Child is 3 - 8 years of age at time of enrollment
Must not have
The parent does not speak English
Child is taking steroid medication for asthma and/or has asthma that is not well controlled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre/post-sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).
Awards & highlights

Summary

This trial is looking at the effects of music therapy on stress and immune function in children with cancer and their parents.

Who is the study for?
This trial is for children aged 3-8 with B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma, currently in induction therapy. A parent over 18 must attend all sessions. Excluded are children with Ph+ ALL, Cushing disease, certain treatment protocols, uncontrolled asthma, steroid medication for asthma, non-English speaking parents, or significant cognitive impairments.
What is being tested?
The study tests how Active Music Engagement (AME) and listening to audio storybooks affect stress hormones and immune function in young kids with cancer and their parents during ALL treatment. It's a randomized trial comparing the biological impact of these interventions.
What are the potential side effects?
Since this trial involves music play and audio storybooks as interventions rather than medications or invasive procedures, traditional side effects are not expected; however emotional responses to music therapy may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child has been diagnosed with a serious form of leukemia or lymphoma.
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My child is between 3 and 8 years old.
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My child is undergoing initial cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I, as a parent, do not speak English.
Select...
My child is on steroids for asthma or their asthma isn't well managed.
Select...
My child has Ph+ acute lymphoblastic leukemia.
Select...
My child has Cushing disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre/post-sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre/post-sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Child Health Questionnaire-Mental Health Subscale (CHQ)
Change in Child and Parent Stress (Salivary Cortisol)
Change in Immunomodulatory Cytokines (children only) (blood)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active Music EngagementExperimental Treatment1 Intervention
See intervention description.
Group II: Audio StorybooksActive Control1 Intervention
See intervention description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Music Engagement
2016
N/A
~140

Find a Location

Who is running the clinical trial?

UCSF Benioff Children's Hospital OaklandOTHER
79 Previous Clinical Trials
18,801 Total Patients Enrolled
James Whitcomb Riley Hospital for ChildrenOTHER
4 Previous Clinical Trials
2,112 Total Patients Enrolled
Riley Hospital for Children at Indiana University HealthUNKNOWN

Media Library

Active Music Engagement Clinical Trial Eligibility Overview. Trial Name: NCT04400071 — N/A
Acute Lymphoblastic Leukemia Research Study Groups: Audio Storybooks, Active Music Engagement
Acute Lymphoblastic Leukemia Clinical Trial 2023: Active Music Engagement Highlights & Side Effects. Trial Name: NCT04400071 — N/A
Active Music Engagement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04400071 — N/A
~39 spots leftby Jun 2025
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