This clinical trial finds out the biology and benefits of music play and stories for children and their parents during B cell acute lymphoblastic leukemia treatment. Play activities, like stories and music, may be used to help decrease parent and child’s stress and improve quality of life during cancer treatment. These programs may also help them both cope better with treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04400071.
PRIMARY OBJECTIVES:
I. Compare the magnitude of change in child and parent cortisol levels between active music engagement (AME) and control during acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LyLy) treatment.
II. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL and LyLy treatment.
EXPLORATORY OBJECTIVE:
I. Examine the dose-response relationship of AME on child and parent cortisol during ALL and LyLy treatment.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (AME): Participants attend weekly sessions over 30 minutes each with a board-certified music therapist for 4 weeks for children with standard risk and 8 weeks for children with high risk. During the sessions, the music therapist leads the participants in a variety of music play activities. Participants also receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. Parents participate in interviews to understand any perceived benefits, as well as potential mechanisms action.
GROUP II (ATTENTION CONTROL): Participants attend weekly sessions over 30 minutes each with a board-certified music therapist for 4 weeks for children with standard risk and 8 weeks for children with high risk. During the sessions, participants choose, view and listen to an illustrated storybook with audio-recorded narration.
In both groups, parents and children undergo saliva collection before and after the first 4 sessions with the music therapist. Children undergo blood sample collection.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorSheri Robb