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

NCT06853158 | Recruiting DMC

• 2 other identifiers: 54487R01AT012508-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Keywords

feasibility, music therapy, QoL, Sickle cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Data quality and completeness (90% goal)

  through study completion, an average of 1 year

• Successful Screening Rate of Enrolled Individuals (35% goal)

  At enrollment

• Successful Recruitment of Participants into the Study (90% goal)

  At Enrollment

• Successful Retention of Participants (70% goal)

  through study completion, an average of 1 year

• Successful Individual Attendance of Study Sessions (70% goal)

  through study completion, an average of 1 year

Other Outcomes (3)

• Participant Satisfaction Question 1

  At 6 week follow-up

• Participant Satisfaction Question 2

  At 6 week follow-up

• Provider Satisfaction Question 1

  through study completion, an average of 1 year

Study Arms (3)

InMT

EXPERIMENTAL

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

HybMT

EXPERIMENTAL

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

HybHE

ACTIVE COMPARATOR

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

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.

HybMT; InMT

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.

HybHE

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a. A diagnosis of SCD confirmed by laboratory testing (present in EHR per eligibility criteria 2)
• b. 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)
• c. 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;
• d. There is no other diagnosis that better explains the signs and symptoms (to be obtained from providers following referral and pre-screening)
• \. Be able to speak and understand English;
• \. Have an email address and access to mobile device with a functioning data plan

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: collaborator
• Prisma Health-Upstate: collaborator
• University of Massachusetts Chan Medical School, Worcester: collaborator
• University of California, San Francisco: collaborator
• University of California, Irvine: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

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

Cleveland, Ohio, 44106, United States

RECRUITING

Prisma Health Lifespan Comprehensive SCD Program

Greenville, South Carolina, 29605, United States

NOT YET RECRUITING

Related Publications (1)

• 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):e115036. doi: 10.1136/bmjopen-2025-115036.

  PMID: 41802789 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jeffery A Dusek, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffery A Dusek, PhD

CONTACT

949-824-8841; jdusek@hs.uci.edu

Coretta Jenerette, PhD, RN

CONTACT

415-502-4242; Coretta.Jenerette@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Multiple Principal Investigators (Drs. Dusek and Jenerette) will be unaware of treatment assignment as will the site PIs. The statisticians who will be assessing feasibility will also be unaware of treatment assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Type/design of trial This is a multi-site, multi-visit feasibility RCT of three wellbeing interventions among patients aged 14 and older with SCD. Specific unit(s) of assignment and unit(s) of observation The unit of assignment is at the patient level. Specifically, patients with SCD enrolled from SCD centers will be randomly assigned to either InMT, HybMT or HybHE. The unit of observation is the patient.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 28, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)