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

NCT03085927 | Completed Results DMC

• 1 other identifier: R01NR015789
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer

Keywords

music therapy; neoplasms; play; children; parents

Outcome Measures

Primary Outcomes (8)

• Family Normalcy Perspective - Family Management Measure (FaMM)

  Family Normalcy is assessed through The Family Management Measure (FaMM) - Family Life Difficulty Subscale includes 14-items rated on a 5-point Likert-type scale. Subscale items address parents' perceptions of the extent to which having a child with a chronic condition makes family life difficult. Higher values indicate more difficulty managing the condition. Score range 14 - 70.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Parent Self-Efficacy - Parental Beliefs Scale (PBS).

  Parent Self-Efficacy is assessed through the Parental Beliefs Scale (PBS) for Hospitalized Children, a 20-item scale that measures parental beliefs about their confidence in anticipating changes in their hospitalized child's behavior and confidence in their parental role during hospitalization. Scores range from 20-100, with higher scores indicating more positive beliefs.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Child Emotional Distress - Child Health Questionnaire (CHQ)

  Child Emotional Distress is assessed through the Child Health Questionnaire (CHQ-PF98) Mental Health Subscale (Landgraf et al., 1999). This subscale consists of 16 items rated on a 5-point Likert-scale. Scores range from 16 to 80 with lower scores indicating better mental health.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Child Quality of Life - KINDL.

  Child Quality of Life is assessed through the KINDL Questionnaire for Measuring Health-Related Quality of Life in Children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale for each subscale. Scores range from 20-100 with higher scores indicating better quality of life.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).

  Parent Emotional and Traumatic Distress was assessed through the Profile of Mood States - Short Form (POMS-SF) which measures mood disturbance. There are 37 items which respondents rate on a 5-point Likert scale. Scores range from 0 to 148 with higher scores indicating greater mood disturbance.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)

  Stress Symptoms assessed through the 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. Parents respond to each item using a 5-point Likert scale. Scores range from 0 to 12 with higher scores indicating greater traumatic stress symptoms.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Parent Quality of Life - Index of Well Being.

  Parent Quality of Life is assessed through the Index of Well-being, a 9-item semantic differential scale describing present life using adjective extremes. Scores range from 7 to 63 with higher scores meaning greater well-being.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

• Family Function - Family Adaptability and Cohesion Scale (FACES II).

  Family Function is assessed through the Family Adaptability and Cohesion Scale II (FACES II), a 30-item scale of items rated using a 5-point Likert scale. Scores range from 1 to 5, with higher scores meaning higher family adaptability and cohesion.

  Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

Study Arms (2)

Arm 1-Active Music Engagement

EXPERIMENTAL

Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child 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 the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.

Behavioral: Active Music Engagement

Arm II- Audio-Storybooks

EXPERIMENTAL

Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.

Behavioral: Audio Storybooks

Interventions

Active Music Engagement BEHAVIORAL

Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child 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 the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.

Arm 1-Active Music Engagement

Audio Storybooks BEHAVIORAL

Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.

Arm II- Audio-Storybooks

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Children's Healthcare of Atlanta: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (4)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64155, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, 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, Stegenga K, Perkins SM, Stump TE, Moody KM, Henley AK, MacLean J, Jacob SA, Delgado D, Haut PR. Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218266. doi: 10.1177/15347354231218266.

  PMID: 38145309 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Sheri Robb, MT-BC
• Organization: Indiana University School of Nursing

shrobb@iu.edu

317-274-3152

Study Officials

• Sheri L Robb, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 21, 2017
• Study Start: September 26, 2016
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)