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N/A Completed N=136 Randomized Supportive Care

Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents

Source: ClinicalTrials.gov NCT03085927 ↗
Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Family Normalcy Perspective - Family Management Measure (FaMM) — 35.3; 36.2; 34.8; 34.3 score on a scale

Summary

Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined the mechanisms by which music therapy interventions work. This study investigates behavioral, social, and psychological factors that may explain how an Active Music Engagement (AME) intervention (i.e., an interactive, music-based play intervention) works to manage emotional distress and improve positive health outcomes in parents and young children with cancer during treatment. Findings will provide scientific and clinically relevant practice knowledge to guide delivery of music therapy as a complementary therapy.

Outcome Measures

OutcomeResultp-value
PRIMARY
Family Normalcy Perspective - Family Management Measure (FaMM)
35.3; 36.2; 34.8; 34.3
PRIMARY
Parent Self-Efficacy - Parental Beliefs Scale (PBS).
79.0; 81.9; 81.1; 84.3
PRIMARY
Child Emotional Distress - Child Health Questionnaire (CHQ)
23.3; 24.0; 24.1; 22.2
PRIMARY
Child Quality of Life - KINDL.
67.6; 69.1; 70.6; 71.7
PRIMARY
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).
38.0; 42.1; 42.9; 43.4
PRIMARY
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)
2.5; 2.5; 4.7; 4.9
PRIMARY
Parent Quality of Life - Index of Well Being.
47.6; 47.9; 48.2; 46.9
PRIMARY
Family Function - Family Adaptability and Cohesion Scale (FACES II).
35.3; 36.2; 34.8; 34.3

Eligibility Criteria

Inclusion Criteria (Child/Parent):

  • Children ages 3-8 years inclusive.
  • Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.
  • A consistent parent who can be present for all sessions.

Exclusion Criteria (Child/Parent):

  • Child and/or parent do not speak English.
  • Child has a significant cognitive impairment that hinders participation (based on physician judgment).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03085927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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