COMPLETED

Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents

Quick Facts

Study Start:2020-08-07
Study Completion:2025-04-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04400071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Child is 3 - 8 years of age at time of enrollment
  2. * Child has diagnosis of standard or high risk B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LyLy)
  3. * Child is currently receiving induction therapy
  4. * One parent (\>18 years of age) can be present for all sessions.
  1. * Child has Ph+ ALL,
  2. * Child has Cushing disease,
  3. * Child is taking steroid medication for asthma and/or has asthma that is not well controlled,
  4. * The parent does not speak English, or
  5. * The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents).

Contacts and Locations

Principal Investigator

Sheri L Robb, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

UCSF Benioff Children's Hospital
Oakland, California, 94609
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Sheri L Robb, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07
Study Completion Date2025-04-11

Study Record Updates

Study Start Date2020-08-07
Study Completion Date2025-04-11

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia, Pediatric
  • Pediatric Cancer