Mechanisms of Active Music Engagement in Managing Acute Distress and in Improving Positive Health Outcomes in Young Children with Cancer and Their Parents

Status: Active

Description

This early phase I trial studies the mechanisms of active music engagement (AME) in managing acute distress and in improving positive health outcomes in young children with cancer and their parents. AME includes a variety of music play activities and may help decrease parent and young child distress and improve quality of life during cancer treatment.

Eligibility Criteria

Inclusion Criteria

  • The child is 3-8 years of age at time of enrollment
  • Patients with an expected treatment course of at least 3 days to receive moderate to high intensity chemotherapy or anti-microbial therapy (children receiving chemotherapy/anti-microbial therapy are at risk for high symptom distress; 3-day treatment course is required to deliver study conditions and contributes to sample homogeneity)
  • One parent/caregiver (>= 18 years of age) can be present for all sessions (study targets both child and parent/caregiver)

Exclusion Criteria

  • The child and/or parent/caregiver do not speak English
  • The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents)

Locations & Contacts

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Amanda Kay Henley
Phone: 317-278-7749
Email: henley@iu.edu

Missouri

Kansas City
Children's Mercy Hospitals and Clinics
Status: Active
Contact: Kristin Stegenga
Phone: 816-234-3292
Email: kstegenga@cmh.edu

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Min Fu
Phone: 731-563-0529
Email: minfu@mdanderson.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Examine the effects of proximal and distal mediators of the Active Music Engagement (AME) intervention on outcomes for young children with cancer and parents.

II. Examine moderators of the AME intervention on outcomes for young child and parent distress.

III. Explore child physical symptom distress in mediation and moderation models. (Exploratory)

OUTLINE: Participants are randomized to 1 of 2 programs.

PROGRAM A: Participants receive 3 interactive visits from a board-certified music therapist (MT-BC) for 45-60 minutes in the child's hospital room over 3 days. Participants also receive a music kit that includes hand-held rhythm instruments, puppets, and a music compact disc (CD) to use between therapist-led sessions.

PROGRAM B: Participants receive 3 visits from an MT-BC for 45-60 minutes in the child's hospital room over 3 days, and receive an illustrated storybook with audio-taped narration.

After the last visit by the music therapist, participants are followed up at 30 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Indiana University / Melvin and Bren Simon Cancer Center

Principal Investigator
Sheri Robb

Trial IDs

Primary ID IUSCC-0578
Secondary IDs NCI-2018-00513
Clinicaltrials.gov ID NCT03085927