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RECRUITING

NCT06853158

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Official title: MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-02

Completion Date

2027-01-31

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Sickle Cell Disease

Interventions

BEHAVIORAL

Music 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.

OTHER

Health 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.

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 least one of the following signs on clinical exam (to be obtained from providers' clinical notes in the EHR * Palpation of the region of reported pain elicits focal pain or tenderness; * Movement of the region of reported pain elicits focal pain; * Decreased range of motion or weakness in the region of reported pain; * Evidence of skin ulcer in the region of reported pain; * Evidence of hepatobiliary or splenic imaging abnormalities (e.g., splenic infarct, chronic pancreatitis) consistent with the region of reported pain; or * Evidence of imaging abnormalities consistent with bone infarction or avascular necrosis in the region of reported; 3d. There is no other diagnosis that better explains the signs and symptoms (to be obtained from providers following referral and pre-screening) 4\. Be able to speak and understand English; 5\. Have an email address and access to mobile device with a functioning data plan 6\. Reporting that pain interfered with daily activities at least 1-2 days in the past week. Exclusion Criteria: 1. Have a significant visual, hearing, or cognitive impairment 2. Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018 3. Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management 4. Have a planned major medical event in the next 14 weeks such as (but not limited to) childbirth, orthopedic surgery, gene therapy, or stem cell transplant (These criteria do not include blood transfusions, exchange transfusions, or other pharmacologic pain treatment). Qualitative interviews will be conducted with \~24 participants who received the interventions (with equal numbers across the InMT, HybMT and HybHE groups). Participants will be purposively sampled to include equal distribution across sites in proportion to recruitment. Stakeholder surveys and qualitative interviews will be conducted among \~20 relevant staff stakeholders (\~10 per site), including healthcare providers \& staff, music therapists and HybHE interventionists.

Locations (2)

UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center

Cleveland, Ohio, United States

Prisma Health Lifespan Comprehensive SCD Program

Greenville, South Carolina, United States