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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
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
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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?
James Whitcomb Riley Hospital for ChildrenOTHER
4 Previous Clinical Trials
2,112 Total Patients Enrolled
Riley Hospital for Children at Indiana University HealthUNKNOWN
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
258 Previous Clinical Trials
5,188,880 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies possible for individuals to join this investigation?
"According to clinicaltrials.gov, the initial posting for this medical experiment was made on August 7th 2020 and its details were revised lastly on October 18th 2022. The trial is still actively recruiting participants."
Answered by AI
Does this clinical research include elderly participants?
"In keeping with the study requirements, only children between the ages of 3 and 8 are eligible for participation."
Answered by AI
Are there any restrictions for becoming a study participant in this trial?
"The current trial is hoping to recruit 250 individuals diagnosed with Acute Lymphocytic Leukemia, aged between 3 and 8."
Answered by AI
What is the current enrollment level for this clinical research?
"Affirmative, as clinicaltrials.gov suggests that this investigation is currently inviting participants to take part in the study. This trial commenced on August 7th 2020 and has seen its last update on October 18th 2022; furthermore, 250 individuals are being sought from 3 distinct medical establishments."
Answered by AI
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