MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University of California, Irvine
Study ID
NCT06853158
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Music therapy — BEHAVIORAL
    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.
  • Health education — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Jan 2026
Primary completion
Dec 14, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: InMT
    Participants in the InMT will receive 6 in-person MT sessions at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center).
  • Experimental: HybMT
    Individuals randomized to Hybrid MT will receive 1 in-person MT session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual MT sessions over secure telehealth platform (e.g. Zoom Health Professional).
  • Active Comparator: HybHE
    Participants in the HybHE condition will receive 1 in-person health education session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual sessions over secure telehealth platform (e.g. Zoom Health Professional).

Primary Outcome Measure

Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes). [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia CenterClevelandOhio44106
Amma Owusu-Ansah, MD (PRINCIPAL_INVESTIGATOR)
Prisma Health Lifespan Comprehensive SCD ProgramGreenvilleSouth Carolina29605
Alan Anderson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Sickle cell disease
By research site
UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center· Cleveland, OHPrisma Health Lifespan Comprehensive SCD Program· Greenville, SC

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