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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Music therapy; Other: Health education

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffery A Dusek, PhD; Phone Number: 949-824-8841; Email: jdusek@hs.uci.edu
• Study Contact Backup: Name: Coretta Jenerette, PhD, RN; Phone Number: 415-502-4242; Email: Coretta.Jenerette@ucsf.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center
      • Principal Investigator: Amma Owusu-Ansah, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Not yet recruiting
      • Prisma Health Lifespan Comprehensive SCD Program
      • Principal Investigator: Alan Anderson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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).	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.
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).	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data quality and completeness (90% goal)	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%	through study completion, an average of 1 year
Successful Screening Rate of Enrolled Individuals (35% goal)	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%.	At enrollment
Successful Recruitment of Participants into the Study (90% goal)	This translates into randomizing 90% participants who provided written informed consent	At Enrollment
Successful Retention of Participants (70% goal)	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.	through study completion, an average of 1 year
Successful Individual Attendance of Study Sessions (70% goal)	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).	through study completion, an average of 1 year
Successful Individual Home Practice (70%)	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.	At 6 week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction Question 1	Enrolled participants will be asked "How satisfied are you with how your pain was managed during your participation in the study" on the 5-point Likert scale (1-strongly dissatisfied-5-very satisfied). Qu 1 will be asked at treatment completion and at 6-week follow up.	At 6 week follow-up
Participant Satisfaction Question 2	Enrolled participants will be asked ""Overall how satisfied are you with your treatment during your study participation?" on the same 5-point Likert Scale. Qu 2 will be asked at treatment completion and at 6-week follow up.	At 6 week follow-up
Provider Satisfaction Question 1	Providers will be asked: "To what degree do you view the InMT, HybMT or HybHE intervention as useful or suitable for this population?" (1- very inappropriate-5-very appropriate).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, San Francisco; National Center for Complementary and Integrative Health (NCCIH); Case Western Reserve University; Prisma Health-Upstate; University of Massachusetts Chan Medical School, Worcester
• Investigators: Principal Investigator: Jeffery A Dusek, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: feasibility, music therapy, QoL, Sickle cell
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: 5448; 7R01AT012508-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No