eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation

The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Stem Cell Transplantation; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Intervention / Treatment: Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT); Behavioral: eHealth Mindfulness Meditation (eMM)

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank J Penedo, PhD; Phone Number: (305) 284-4290; Email: fpenedo@miami.edu
• Study Contact Backup: Name: Sara E Fleszar-Pavlovic, PhD; Phone Number: (305) 243-4009; Email: sarafleszarpavlovic@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Principal Investigator: Frank J Penedo, PhD
      • Contact: Juan Caffroni; Phone Number: 305-243-4445; Email: jcc281@med.miami.edu

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 a hematologic malignancy (e.g., myelodysplastic syndrome [MDS], acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or non Hodgkin's Lymphoma [NHL])
• have a treatment plan for a 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 the prior pilot MBMT R61 phase
• 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: eHealth Mindfulness-based Music Therapy (eMBMT); Participants will be in the MBMT group for 5 months.	Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT); 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: eHealth Mindfulness Meditation (eMM); Participants will be in the MM group for 5 months.	Behavioral: eHealth Mindfulness Meditation (eMM); 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
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.	(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.	Baseline (T1), up to 18 months
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.	(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.	Baseline (T1), up to 18 months
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
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 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 Thymic Function	Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.	Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Regulatory T cells	Regulatory T cells measured as cells/mm^3	Baseline (T1), up to 18 months
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)	Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)	Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).	The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.	Baseline (T1), up to 18 months
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)	PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.	Baseline (T1), up to 18 months
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).	GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.	Baseline (T1), up to 18 months
Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay	Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a >3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.	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

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 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
• Other Study ID Numbers: 20250732; R33CA263335 (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