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

NCT04400071 | Completed DMC

• 2 other identifiers: R01NR0191905R01NR019190-05
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric; Pediatric Cancer

Outcome Measures

Primary Outcomes (7)

• Change in Child and Parent Stress (Salivary Cortisol)

  We will measure salivary cortisol (a steroid hormone) as a biological indicator of stress. Cortisol is one of the most frequently used biomarkers for stress and has been used in several cancer studies.

  Pre/Post-Sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).

• Change in Immunomodulatory Cytokines (children only) (blood)

  We will measure serum levels of IL-1β, IL-6, TNF-α, IFN-γ, IL-4, IL-10, and IL-13. The activation of the HPA-axis has been reported to shift to promote the secretion of anti-inflammatory cytokines (IL-4, IL-10, IL-13) and decrease pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IFN-γ) and thus modulate immune function.

  Pre-Session Week 1 and Week 4 (all child participants); and Pre-Session Week 8 (only high risk child participants).

• Change in Child Health Questionnaire-Mental Health Subscale (CHQ)

  Measures the frequency of both negative and positive states. Items capture anxiety, depression, and positive affect. We chose the parent-report version due to our targeted child age range of 3-8 years; parent-proxy and child self-report measures are scored differently, so we elected to use parent-proxy for all children. The subscale includes 16 parent-report items on a 5-point Likert-scale, ranging from 1 (none of the time) to 5 (all of the time). Scores range from 16-80 with higher scores indicating better mental health. Across 25 subgroups, the median Cronbach alpha coefficient for the subscale was .76, coefficients ranged from .67 to .86.

  Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)

• Change in KINDLR Questionnaire for Measuring Health-Related Quality of Life in Children

  Measures global quality of life. The KINDL is used widely and has been translated into 11 languages. It was selected over other well-known measures for its positive health perspective, especially for younger children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale, ranging from 1 (never) to 5 (all the time). There are 6 subscales: Physical well-being, Emotional Well-being, Self-Esteem, Family, Friends, and Everyday Functioning. We will use 20 items in 5 subscales, omitting the Everyday Functioning subscale, because it is focused on school-related functioning and children may not be attending school. Scores range from 20 - 100 with higher scores indicating better quality of life. KINDL parent-report is a valid and reliable measure for children as young as age 3. The KINDL has satisfactory convergent and discriminant validity, and a Cronbach alpha of .89 for the total scale.

  Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).

• Change in Profile of Mood States - Short Form (POMS-SF)

  Measures mood disturbance. The scale is a self-report, 37-item instrument that yields scores on six subscales (tension-anxiety; depression-dejection; anger-hostility; vigor-activity; fatigue-inertia; confusion-bewilderment) and a total mood disturbance score. Respondents are given 37 adjectives used to describe feelings during the last week and asked to respond to each item using a 5-point Likert scale (0 = not at all; 4 = extremely). Higher scores equal greater mood disturbance. Construct validity is widely supported. The POMS-SF strongly correlates with the original 65-item POMS (r = 0.99) and is one of the most commonly used measures for parent emotional distress in pediatric cancer research.

  Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).

• Change in Impact of Events Scale - Revised (IES-R)

  A 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions. In our study, parents will respond to items in reference to their child's cancer treatment as the stressor. The scale includes three subscales: intrusion, avoidance, and hyperarousal. Parents respond to each item using a 5-point Likert scale (0 = not at all; 4 = extremely). Higher scores indicate greater traumatic stress symptoms. The IES-R has been used in studies of childhood cancer patients and their parents. Cronbach's alpha for Intrusion, Avoidance, and Hyperarousal scales were .91, .84, and .90 respectively.

  Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants).

• Change in Index of Well-being

  A 9-item semantic differential scale describing present life using adjective extremes such as discouraging/hopeful. Higher scores mean greater well-being. The scale has well established construct validity and a reported Cronbach alpha of .93 for the total scale.

  Baseline; Post-Session Week 4 (standard risk participants); Post-Session Week 8 (high risk participants)

Study Arms (2)

Active Music Engagement

EXPERIMENTAL

See intervention description.

Behavioral: Active Music Engagement

Audio Storybooks

ACTIVE COMPARATOR

See intervention description.

Behavioral: Audio Storybooks

Interventions

Active Music Engagement BEHAVIORAL

Weekly 45-minute sessions with a board-certified music therapist delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. During the first visit, parent and child will receive information on how they can use music play activities to help manage distress during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During subsequent visits the music therapist will lead parent and child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.

Active Music Engagement

Audio Storybooks BEHAVIORAL

Weekly 45-minute sessions with a trained provider delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. Each session children/parents will choose and listen to one of three illustrated children's books with audio-recorded narration.

Audio Storybooks

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead
• Children's Mercy Hospital Kansas City: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Institute of Nursing Research (NINR): collaborator
• James Whitcomb Riley Hospital for Children: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator

Study Sites (4)

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (4)

• 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.

  PMID: 18033724 BACKGROUND

• 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.

  PMID: 27289068 BACKGROUND

• 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.

  PMID: 10932125 BACKGROUND

• Robb SL, Russ KA, Holochwost SJ, Stegenga K, Perkins SM, Jacob SA, Henley AK, MacLean JA. Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents. BMC Complement Med Ther. 2023 Mar 27;23(1):90. doi: 10.1186/s12906-023-03909-w.

  PMID: 36973774 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sheri L Robb, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study personnel responsible for administering self report measures will be blinded to participant's study condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 22, 2020
• Study Start: August 7, 2020
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)