Recruiting

Mindfulness-Based Music Therapy

Sponsor:

University of Miami

Code:

NCT07469592

Conditions

Stem Cell Transplantation

Myelodysplastic Syndromes

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

eHealth Mindfulness-based Music Therapy (eMBMT)

eHealth Mindfulness Meditation (eMM)

Study Details

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

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Non-Hodgkin

Study ID

NCT07469592

Start date

Jul 22, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: eHealth Mindfulness-based Music Therapy (eMBMT)

Participants will be in the MBMT group for 5 months.

experimental: eHealth Mindfulness Meditation (eMM)

Participants will be in the MM group for 5 months.

Interventions

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.

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.

Primary outcome measure

  • Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale. [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale. [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE). [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index [ Time Frame: Baseline (T1), up to 18 months ]
  • Number of Days to Engraftment Measured from Infusion to Engraftment. [ Time Frame: Up to 18 months ]
  • Number of Days of Hospitalization Measured from Admission to Engraftment. [ Time Frame: Up to 18 months ]
  • Number of Hospital Readmissions after Hospital Discharge [ Time Frame: Up to 100 days ]
  • Number of Infections from Hospital Admission [ Time Frame: up to 100 Days Post-Infusion Day ]
  • Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9) [ Time Frame: Baseline (T1), up to 18 months ]
  • Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7). [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Serum Cortisol as Measured by ELISA [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Immunocompetence as Measured by Thymic Function [ Time Frame: Baseline (T1), up to 18 months ]
  • Change in Immunocompetence as Measured by Regulatory T cells [ Time Frame: Baseline (T1), up to 18 months ]

Central Contacts and Locations

Central contacts

Frank J Penedo, PhD

(305) 284-4290fpenedo@miami.edu

Sara E Fleszar-Pavlovic, PhD

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

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tea Kostreni

305-243-4445txk706@med.miami.edu

Principal Investigator:

Frank J Penedo, PhD

More Information

Sponsor

University of Miami

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-13.