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

Official title

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

Overview

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.

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

Primary outcome measures

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

Secondary outcome measures (6)

• Data quality and completeness (90% goal) [Time frame: through study completion, an average of 1 year]
• Successful Screening Rate of Enrolled Individuals (35% goal) [Time frame: At enrollment]
• Successful Recruitment of Participants into the Study (90% goal) [Time frame: At Enrollment]
• Successful Retention of Participants (70% goal) [Time frame: through study completion, an average of 1 year]
• Successful Individual Attendance of Study Sessions (70% goal) [Time frame: through study completion, an average of 1 year]
• Successful Individual Home Practice (70%) [Time frame: At 6 week follow-up]

Eligibility criteria

Inclusion criteria

• Be aged >=14 years old
• Have a diagnosis of SCD present in their electronic health record (EHR);
• 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

• Have a significant visual, hearing, or cognitive impairment
• Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
• Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 2 centers

• UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sic — Cleveland
• Prisma Health Lifespan Comprehensive SCD Program — Greenville

Publications

• Rodgers-Melnick SN, Gorthi V, Foss A, Erande A, DiFrancesco K, Owusu-Ansah A, Anim S, Bretz S, Ketter P, Fuqua T, Anderson AR, Karasz A, Bailey L, Ezenwa M, Jenerette C, Dusek JA. MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres. BMJ Open. 2026 Mar 9;16(3):e1 PMID 41802789

Identifiers

NCT: NCT06853158 · 5448 · 7R01AT012508-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗