Study Protocol for MULTI-MUSIQOLS- Feasibility of Music Therapy in Sickle Cell Disease
Authors: Jenerette Coretta , Rodgers-Melnick Samuel N , Segall Tracy , Dusek Jeffery 
Published: June 2024

Abstract

Presentation Date: 6/9/2024
Presentation Start Time: 1:51:00 PM

Background
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 a longitudinal etiologic study of 232 adults with SCD, patients scored significantly worse than national norms on HRQoL. In their 2020 guidelines for pain management in SCD, the American Society of Hematology acknowledged that pharmacologic approaches have limited effectiveness and non-pharmacologic integrative approaches are beneficial but may have limited accessibility for individuals with SCD. In our prior feasibility study, 24 adults with SCD and chronic pain were randomized to receive either an in-person 6-session music therapy (MT) intervention (n = 12) or waitlist control (WLC) (n = 12). We developed procedures for screening, recruitment, retention, and electronic data collection within this single-site randomized controlled trial (RCT). The enrollment rate was 89%, and 100% of study measures were completed. MT participants demonstrated 100% attendance to in-person MT sessions at the cancer center where the SCD clinic was located. In preliminary analyses, MT participants demonstrated significant mean improvements in self-efficacy (5.42), sleep disturbance (-1.49), pain interference (-2.10), and social functioning impact (2.97) compared to WLC participants. However, this pilot was not adequately powered to detect differences across groups nor is a WLC group an adequate comparison group for RCTs. Furthermore, since that pilot and due to the COVID-19 pandemic, our MT program has been adapted for virtual delivery, with several virtual MT sessions being successfully provided to adults with SCD. We contend that use of a hybrid (i.e., 1 in-person session followed by 5 virtual sessions) MT intervention will be feasible and accessible for adolescents and adults aged 14 and older with SCD. The primary objective is to refine procedures for conducting a future fully-powered multi-site RCT. The secondary objective of the study is to examine the feasibility of completeness of data collection, participant recruitment and rate, participant retention, as well as assessment of hybrid intervention implementation and home practice using study records across the 2 sites. This study will include qualitative interviews to assess feasibility of implementation.

Methods
This is a multi-site, multi-visit feasibility RCT of three wellbeing interventions among patient aged 14 years and older with SCD. Ninety subjects will be recruited from: UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children’s Hospital Sickle Cell Anemia Center (site 1) and Prisma Health Lifespan Comprehensive SCD Program (site 2). Patients with SCD enrolled from SCD centers will be randomly assigned to either in-person MT (InMT), hybrid MT (HybMT) or hybrid health education (HybHE). Subjects will be enrolled for 12 to 14 weeks (6-8 weeks for the intervention and 6 weeks for the final follow-up measures). Participants in the InMT condition will receive 6 in-person MT sessions. Participants in either the HybMT or the HybHE condition will receive 1 in-person session and 5 virtual sessions over a secure telehealth platform. Participant interviews will take place during their 12 to 14 weeks of enrollment, approximately 2-3 weeks after their last session. Participants will enter their responses to the patient reported outcome (PRO) measures directly into REDCap using an iPad provided at baseline or using their own devices (post-intervention and 6-week follow-up). We will also collect data via an electronic health record review for clinical characteristics. Implementation outcomes (acceptability, use of MT exercises and HybHE assignments during and post-intervention will be evaluated with Likert scales, self-report, and REDCap surveys.

Results
Recruitment for this feasibility RCT will begin in May 2024. The study protocol and any updates will be presented.

Conclusions
Successful conduct of the proposed, feasibility RCT will provide the necessary framework for our long-term goal: conducting a future, multi-site, definitive RCT of music therapy compared with health education at multiple sites using the UG3/UH3 mechanism. Completion of the proposed R01 and the subsequent RCT (UG3/UH3) could provide critical evidence to support the inclusion of music therapy as a chronic pain intervention for individuals with SCD. Such an expansion could provide individuals with SCD with culturally relevant, non-pharmacologic methods for managing pain, improving self-efficacy, and reducing the psychosocial burden of SCD.