Clinical trial NCT04400071: Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment
Official title: Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Pediatric Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: National Institute of Nursing Research (NINR)
name: James Whitcomb Riley Hospital for Children
name: UCSF Benioff Children's Hospital Oakland
First posted: 2020-05-22
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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. In addition, few studies have examined dose-response relationships. Cancer treatment is an inherently stressful experience, and a significant number of young children and parents (caregivers) experience persistent, interrelated emotional distress and poor quality of life. Many parents also experience traumatic stress symptoms because of their child's cancer diagnosis and treatment. The investigators previously tested an Active Music Engagement (AME) intervention that uses active music play to diminish stressful attributes of cancer treatment to help manage emotional/traumatic distress experienced by young children (ages 3-8) and parents and improve quality of life. A recent AME trial is examining psychosocial mechanisms of action responsible for change in child/parent outcomes. The current study expands on this work by examining AME's effects on several biomarkers to provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve 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: 1) establish whether AME lowers child and parent cortisol, 2) examine cortisol as a mediator of AME effects on child and parent outcomes, and 3) examine the dose-response relationship of AME on child and parent cortisol. Child/parent dyads (n=250) will be stratified (by age, site, ALL risk level) and randomized in blocks of four to AME or attention control. Each group will receive one 45-minute session during weekly clinic visits for the duration of ALL consolidation (4 weeks standard risk; 8 weeks high risk). Parents will complete measures at baseline and following the last study session. Child and parent salivary cortisol samples will be taken pre and post-session for the first 4 AME or attention control sessions. Child blood samples will be reserved from routine blood draws prior to sessions 1 and 4 (all participants) and session 8 (high risk participants). Linear mixed models will be used to estimate AME's effect on child and parent cortisol. Examining child and parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting, fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate the indirect effect. Graphical plots and non-linear repeated measures models will be used to examine the dose-response relationship of AME on child and parent cortisol.

Eligibility 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).

Primary outcomes:
measure: Change in Child and Parent Stress (Salivary Cortisol)
timeFrame: Pre/Post-Sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).
measure: Change in Immunomodulatory Cytokines (children only) (blood)
timeFrame: Pre-Session Week 1 and Week 4 (all child participants); and Pre-Session Week 8 (only high risk child participants).
measure: Change in Child Health Questionnaire-Mental Health Subscale (CHQ)
timeFrame: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)
measure: Change in KINDLR Questionnaire for Measuring Health-Related Quality of Life in Children
timeFrame: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
measure: Change in Profile of Mood States - Short Form (POMS-SF)
timeFrame: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
measure: Change in Impact of Events Scale - Revised (IES-R)
timeFrame: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).
measure: Change in Index of Well-being
timeFrame: Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Indiana University
name: Sheri L Robb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robb SL, Clair AA, Watanabe M, Monahan PO, Azzouz F, Stouffer JW, Ebberts A, Darsie E, Whitmer C, Walker J, Nelson K, Hanson-Abromeit D, Lane D, Hannan A. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer. Psychooncology. 2008 Jul;17(7):699-708. doi: 10.1002/pon.1301.
citation: Robb SL, Haase JE, Perkins SM, Haut PR, Henley AK, Knafl KA, Tong Y. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. J Pediatr Psychol. 2017 Mar 1;42(2):208-219. doi: 10.1093/jpepsy/jsw050.
citation: Robb SL. The effect of therapeutic music interventions on the behavior of hospitalized children in isolation: developing a contextual support model of music therapy. J Music Ther. 2000 Summer;37(2):118-46. doi: 10.1093/jmt/37.2.118.