MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 14 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 6 visits, 1 visit, 5 visits
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a larger study of music therapy for quality of life in people with sickle cell disease is practical. It is for people age 14 and older with long-term sickle cell pain. Participants are assigned by chance to six visits of music therapy or health education, either all in person or partly online.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 14 or older.
- Have sickle cell disease confirmed by lab tests and listed in your electronic health record.
- Have pain on most days for the past 6 months, in one or more areas.
- Have at least one exam or scan finding in the painful area: pain with touch or movement, limited movement, weakness, a skin sore, or certain changes in organs or bones.
- Have no other diagnosis that better explains the pain and related signs.
- Be able to speak and understand English.
- Have an email address and a mobile device with a working data plan.
- Report that pain affected daily activities on at least 1–2 days in the past week.
Who can't join
- Have major problems with vision, hearing, or thinking.
- Took part in the MUSIQOLS pilot study at University Hospitals in 2018.
- Currently use mind-body therapies specifically for pain under a health professional’s supervision.
- Have a major medical event planned in the next 14 weeks, such as childbirth, bone or joint surgery, gene therapy, or a stem cell transplant. Blood transfusions, exchange transfusions, and pain medicines do not count.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (2)
OH
- UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center · Cleveland, OH 44106Amma Owusu-Ansah, MD · Principal investigatorMore trials in Cleveland
SC
- Prisma Health Lifespan Comprehensive SCD Program · Greenville, SC 29605Alan Anderson, MD · Principal investigatorMore trials in Greenville