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

NCT07469592 | Not Yet Recruiting DMC

• 2 other identifiers: 20250732R33CA263335
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplantation; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (16)

• 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 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 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

• 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

• 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 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 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

• 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

Study Arms (2)

eHealth Mindfulness-based Music Therapy (eMBMT)

EXPERIMENTAL

Participants will be in the MBMT group for 5 months.

Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT)

eHealth Mindfulness Meditation (eMM)

EXPERIMENTAL

Participants will be in the MM group for 5 months.

Behavioral: eHealth Mindfulness Meditation (eMM)

Interventions

eHealth Mindfulness Meditation (eMM) BEHAVIORAL

Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.

eHealth Mindfulness Meditation (eMM)

eHealth Mindfulness-based Music Therapy (eMBMT) BEHAVIORAL

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.

eHealth Mindfulness-based Music Therapy (eMBMT)

Eligibility Criteria

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

You may qualify if:

• ≥ 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

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 the prior pilot MBMT R61 phase
• participated in music therapy or mindfulness programs in the past six months

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Study Officials

• Frank J Penedo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank J Penedo, PhD

CONTACT

(305) 284-4290; fpenedo@miami.edu

Sara E Fleszar-Pavlovic, PhD

CONTACT

(305) 243-4009; sarafleszarpavlovic@med.miami.edu

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: February 18, 2026
• First Posted: March 13, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)