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

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease

• Registration Number: NCT06853158
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed 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).

Three wellbeing programs for individuals with SCD will be compared: (1) InMT, (2) HybMT, and (3) HybHE. Each intervention includes 6 sessions. The treatment period for each group will be 6 to 8 weeks. Each weekly session will last up to one hour in all arms of the study. MT sessions in the InMT and HybMT arms will include the topics of SCD education and MT rationale, breathing exercises, relaxation, imagery, music making, and review and creation of a coping plan for future challenges. The HybHE group will use an adapted version of Project Patients Empowered and Educated Providers (PEEP). Covered topics include: science of SCD, identifying barriers in the Emergency Department, tools for navigating the healthcare system, healthcare based communication, and review and planning for future challenges.

Semi-structured qualitative interview topics will focus on participants' perceptions of the interventions, perceived benefits and burdens of the interventions, and other barriers and facilitators to in-person and hybrid delivery.

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Study Start: 2025-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Be aged 14 years or older;
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 both sexes, younger and older participants, and 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes).	through study completion, an average of 1 year	There are 6 feasibility metrics: (1) Data quality (90%), (2) Screening rate (35%), (3) Recruitment rate (90%), (4) Retention rate (70%), (5) Individual attendance (70%) and (6) Home practice (70%). A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics are met.

Secondary Outcome Measures

Name	Time	Method
Data quality and completeness (90% goal)	through study completion, an average of 1 year	This variable is described as being the number of data elements that are correctly completed in the Multi Musiqols REDCap project. The feasibility goal is 90%
Successful Screening Rate of Enrolled Individuals (35% goal)	At enrollment	The screening rate as those who were enrolled (i.e., provide written informed consent) divided by those approached for the study who met eligibility criteria. The feasibility goal is 35%.
Successful Recruitment of Participants into the Study (90% goal)	At Enrollment	This translates into randomizing 90% participants who provided written informed consent
Successful Retention of Participants (70% goal)	through study completion, an average of 1 year	This metric is defined as the number of participants retained until the final survey time point (6-week follow-up) divided by the number of randomized participants.
Successful Individual Attendance of Study Sessions (70% goal)	through study completion, an average of 1 year	We will consider individual attendance to be acceptable if a given participant attends 4 of 6 sessions in 8 weeks. These 4 sessions must include the first session and any 3 out of the 4 sessions between sessions 2-5. Individual session attendance will be deemed complete if the participant attends 2/3 of the session including (1) the introduction (discussing experience with the MT or HybHE exercise over previous week, providing education on rationale for intervention); (2) setting of the agenda; and (3) the main intervention (e.g., co-creating the music for the intervention, customizing the place and imagery to participants' preferences, experiencing and recording the intervention).
Successful Individual Home Practice (70%)	At 6 week follow-up	If a given participant practices intervention exercises at least once per week, this will be coded as engaging in the minimum dose of home practice.

Trial Locations

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