MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS)

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Individuals with sickle cell disease (SCD) often endure multiple acute pain crises throughout their lives. The cumulative impact of these crises and physical complications contribute to the emergence of chronic pain syndromes, mental health conditions, and impaired health-related quality of life (HRQoL) in early adolescence that persist through adulthood. In their 2020 pain management guidelines for SCD, the American Society of Hematology acknowledged the limited effectiveness of pharmacologic approaches and the potential benefits of nonpharmacologic integrative approaches such as music therapy (MT). These guidelines identified research priorities including determining which nonpharmacologic therapies are most acceptable and developing manualized, accessible, and developmentally appropriate interventions for chronic SCD pain. In our prior single-site feasibility study, 24 adults with SCD and chronic pain were randomized to receive either an in-person 6-session MT intervention (n = 12) or waitlist control (WLC) (n = 12). We developed procedures for screening, recruitment, retention, and electronic data collection within this randomized controlled trial (RCT). The enrollment rate was 89%, all study measures were completed, and MT participants demonstrated 100% attendance as well as improvements in self-efficacy and HRQoL compared to WLC participants. While results from this pilot RCT are promising, to scale an intervention in preparation for a future, multi-site, pragmatic, definitive RCT, further steps are needed. Furthermore, with MT being increasingly adapted for virtual delivery, including among adults with SCD, trials are needed to investigate the feasibility of hybrid (i.e., one in-person and five virtual sessions) approaches to MT delivery. In this R01, we propose to examine the feasibility of a multi-site study enrolling (1) in-person MT (n=30), (2) hybrid MT (n=30), and (3) hybrid Health Education (HealthEd) (n=30). Our proposal includes the MULTI-MUSIQOLS Data Coordinating Center at University of California Irvine and two recruiting sites: University Hospitals/Case Western Reserve University and Prisma Health/University of South Carolina. A total of 90 subjects will be randomized to either in-person MT, hybrid MT, or hybrid Health Education (HealthED) (1:1:1 allocation) with a focus on feasibility of data collection, participant recruitment, delivery of interventions, and home practice. Our Specific Aims are: AIM 1) conduct a feasibility RCT to examine the data collection processes and intervention (in-person MT, hybrid MT, and hybrid HealthED) implementation overall and across 2 sites; and AIM 2) evaluate the implementation of the in-person MT, hybrid MT, and hybrid HealthED interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews). Successful conduct of the proposed, feasibility RCT will provide the necessary framework for conducting a future, multi-site, pragmatic, RCT of MT compared with HealthED. Completion of the proposed R01 and the subsequent RCT (UG3/UH3) could provide critical evidence to support inclusion of MT as a chronic pain intervention for individuals with SCD and other similar populations.