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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03085927.
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 PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorSheri Robb
