MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)
University of California, Irvine
Summary
This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD). Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE). Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule. The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met. This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.
Description
The objectives of this study are to (1) conduct a feasibility randomized control trial (RCT), to examine the data collection processes, and intervention (in-person music therapy \[InMT\], hybrid MT \[HybMT\], and hybrid health education \[HybHE\]) implementation overall and across 2 sites (University Hospitals/Case Western Reserve University \[site 1\] and Prisma Health/University of South Carolina \[site 2\]); and (2) evaluate the implementation of the InMT, HybMT, and HybHE interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews). Thr…
Eligibility
- Age range
- 14+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be aged \>=14 years old 2. Have a diagnosis of SCD present in their electronic health record (EHR); 3. Meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain which includes: 3a. A diagnosis of SCD confirmed by laboratory testing (present in EHR per eligibility criteria 2) 3b. Reports of ongoing pain present on most days over the past 6 months either in a single location or in multiple locations (to be obtained at screening) 3c. Displaying at…
Interventions
- BehavioralMusic therapy
Participants in the 2 experimental MT conditions (In person MT (InMT) or hybrid (inperson.virtual (HybMT) will receive 6 MT sessions over 6 weeks. Each MT session will last no longer than one hour. This 6-week treatment period may be extended to up to 8 weeks if a scheduling conflict prevents a participant from receiving the 6 MT sessions over 6 consecutive weeks.
- OtherHealth education
The content for the HybHE control was adapted from Project PEEP: Patients Empowered and Educated Providers. The Sickle Cell Community Consortium developed Project PEEP with a grant from Global Blood Therapeutics. Project PEEP addresses unmet needs directly identified and prioritized by a collective of patients with SCD, caregivers, and community-based organizations. The objective is to provide the tools and resources to improve communication and increase positive patient-provider interactions to receive quality, timely care. For the proposed study, we will use modules from the curriculum developed for patients living with SCD.
Locations (2)
- UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia CenterCleveland, Ohio
- Prisma Health Lifespan Comprehensive SCD ProgramGreenville, South Carolina