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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
No Placebo-Only Group
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 belowSelect...
My child has been diagnosed with a serious form of leukemia or lymphoma.
Select...
My child is between 3 and 8 years old.
Select...
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 weeks3 visits
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).
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).
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,100 Total Patients Enrolled
Riley Hospital for Children at Indiana University HealthUNKNOWN
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
273 Previous Clinical Trials
5,185,323 Total Patients Enrolled
Children's Mercy Hospital Kansas CityOTHER
257 Previous Clinical Trials
940,246 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,634 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,466 Total Patients Enrolled
Sheri L Robb, PhDPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I, as a parent, do not speak English.My child is on steroids for asthma or their asthma isn't well managed.My child has Ph+ acute lymphoblastic leukemia.I can have a parent over 18 with me at all sessions.My child has been diagnosed with a serious form of leukemia or lymphoma.My child has Cushing disease.My child is between 3 and 8 years old.My child is undergoing initial cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Audio Storybooks
- Group 2: Active Music Engagement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.