Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation

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).

Study Overview

• Status: Completed
• Conditions: Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Stem Cell Transplantation; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Intervention / Treatment: Behavioral: Mindfulness-based Music Therapy (MBMT); Behavioral: Mindfulness Meditation (MM)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based Music Therapy (MBMT); Participants will be in the MBMT group for 5 months.	Behavioral: Mindfulness-based Music Therapy (MBMT); 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.
Experimental: Mindfulness Meditation (MM); Participants will be in the MM group for 5 months.	Behavioral: Mindfulness Meditation (MM); Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Retained	Participant retention will be examined via the number of participants retained in the study.	Up to 18 months
Count of Participants Recruited	Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.	Baseline (T1)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.	Baseline (T1), up to 18 months
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised	Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.	Baseline (T1), up to 18 months
Change in Serum Cortisol as Measured by ELISA	Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation	Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Cytokines	Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation	Baseline (T1), up to 18 months
Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) assesses health-related quality of life in bone marrow transplant recipients. Scores range from 0-164, with higher scores indicating better quality of life.	Baseline (T1), up to 18 months
Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.	PROMIS® Pain Interference Short Form 8a is scored as a T-score, ranging from 40.7 to 77.0, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater pain interference.	Baseline (T1), up to 18 months
Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.	PROMIS® Fatigue Short Form 8a is scored as a T-score, ranging from 33.1 to 77.8, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater fatigue.	Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation	Fast Cognitive Evaluation (FaCE) score range from 0 to 27. Higher score indicates better cognitive function.	Baseline (T1), up to 18 months
Number of Days to Engraftment Measured From Infusion to Engraftment.	To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.	Up to 18 months
Number of Days of Hospitalization Measured From Admission to Engraftment.	To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.	Up to 18 months
Number of Hospital Readmissions After Hospital Discharge	To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.	Up to 100 days
Number of Infections From Hospital Admission	To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.	up to 100 Days Post-Infusion Day
Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7)	Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.	Baseline (T1), up to 18 months
Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9)	PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.	Baseline (T1), up to 18 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Frank J. Penedo, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): May 26, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: 20230726; 1R61CA263335-01A1 (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