Clinical trial NCT03085927: Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
Official title: Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: music therapy
neoplasms
play
children
parents
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
name: Children's Mercy Hospital Kansas City
name: M.D. Anderson Cancer Center
First posted: 2017-03-21
Enrollment: 137
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, 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.

Detailed description: Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined mechanisms by which music therapy interventions work.Based on the Contextual Support Model of Music Therapy, the investigators developed and tested the Active Music Engagement (AME) intervention, establishing it as a feasible and acceptable intervention that reduces emotional distress in young children (ages 3-8) hospitalized for cancer treatment.Emotional distress in young children with cancer during acute treatment and their parents is a prevalent,persistent problem associated with physical symptom distress and diminished quality of life and family function. The music therapist-led AME uses music-based play and parent education/support (music play resource kit; tip sheets), is easy to implement, and teaches parents/children how to therapeutically use a familiar activity to manage distress. The purpose of this two group randomized controlled trial is to identify behavioral, sociological, and psychological variables contributing to positive outcomes observed in previous AME studies (i.e., mediators) and identify for whom the intervention works (i.e., moderators). The investigators will examine proximal mediators of child engagement and parent-child interaction and distal mediators of perceived family normalcy, parent confidence (self-efficacy) about their ability to support their child during treatment, and independent parent/child use of music and play activities to manage distress during hospitalization. The investigators hypothesize these factors mediate change in outcomes of child emotional distress, physical symptom distress, and quality of life; parent emotional/traumatic distress and quality of life; and family function. Specific aims are to examine: 1) effects of proximal and distal mediators of AME on young child/parent outcomes; 2) moderators of AME on young child/parent distress; 3) explore child physical symptom distress (pain, fatigue, nausea) in mediation and moderation models. Child/parent dyads (n=184) will be stratified by age and randomized in blocks of 6 to AME or audio-storybooks; each group will receive three 45-minute sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention, and 30 days later. Mediation effects will be estimated using ANCOVA, fitting appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate indirect effect. Moderation effects will be tested by including appropriate interaction terms of the potential moderator with the intervention indicator in our models.

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).

Primary outcomes:
measure: Family Normalcy Perspective - Family Management Measure (FaMM)
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Parent Self-Efficacy - Parental Beliefs Scale (PBS).
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Child Emotional Distress - Child Health Questionnaire (CHQ)
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Child Quality of Life - KINDL.
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Parent Quality of Life - Index of Well Being.
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
measure: Family Function - Family Adaptability and Cohesion Scale (FACES II).
timeFrame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
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.