Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
2 other identifiers
interventional
61
1 country
1
Brief Summary
The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2025
CompletedResults Posted
Study results publicly available
August 12, 2026
CompletedAugust 12, 2026
July 1, 2026
1.5 years
July 19, 2023
May 23, 2026
July 20, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Count of Participants Recruited
Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.
Baseline (T1)
Number of Participants Retained
Participant retention will be examined via the number of participants retained in the study.
Up to 18 months
Mean Number of Intervention Sessions That Participants Completed
Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant.
Up to 100 days post-transplant
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
Up to 100 days post-transplant
Secondary Outcomes (14)
Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Baseline (T1), up to 18 months
Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.
Baseline (T1), up to 18 months
Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.
Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation
Baseline (T1), up to 18 months
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Baseline (T1), up to 18 months
- +9 more secondary outcomes
Study Arms (2)
Mindfulness-based Music Therapy (MBMT)
EXPERIMENTALParticipants will be in the MBMT group for 5 months.
Mindfulness Meditation (MM)
EXPERIMENTALParticipants will be in the MM group for 5 months.
Interventions
Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL)
- have a treatment plan for an allogeneic hematopoietic stem cell transplant
- Speak English or Spanish
You may not qualify if:
- history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
- severe cognitive impairment (per the short portable mental status questionnaire)
- hearing impairment
- active alcohol or substance dependence within the past six months
- participated in music therapy or mindfulness programs in the past six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Related Publications (1)
Fleszar-Pavlovic SE, Esquives BN, Brito AE, Sia AM, Kauffman MA, Lopes M, Moreno PI, Koru-Sengul T, Gong R, Wang T, Wieder ED, Rueda-Lara M, Antoni M, Komanduri K, Lesiuk T, Penedo FJ. eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107577. doi: 10.1016/j.cct.2024.107577. Epub 2024 May 17.
PMID: 38763308DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Frank Penedo
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Frank J. Penedo, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2023
First Posted
August 1, 2023
Study Start
November 28, 2023
Primary Completion
May 26, 2025
Study Completion
June 4, 2025
Last Updated
August 12, 2026
Results First Posted
August 12, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share