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Completed

NCT Number: NCT05968963

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).

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Key information

Conditions

Stem Cell Transplantation Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Music Therapy (MBMT)

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.

Mindfulness Meditation (MM)

Behavioral

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

Primary outcomes

  1. Count of Participants Recruited

    Time frame: Baseline (T1)

    Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.

  2. Number of Participants Retained

    Time frame: Up to 18 months

    Participant retention will be examined via the number of participants retained in the study.

  3. Mean Number of Intervention Sessions That Participants Completed

    Time frame: Up to 100 days post-transplant

    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.

  4. Satisfaction Scores as Measured by Weekly Rating Satisfaction Score

    Time frame: Up to 100 days post-transplant

    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.

Secondary outcomes

  1. Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

    Time frame: Baseline (T1), up to 18 months

    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.

  2. Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.

    Time frame: Baseline (T1), up to 18 months

    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.

  3. Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.

    Time frame: Baseline (T1), up to 18 months

    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.

  4. Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation

    Time frame: Baseline (T1), up to 18 months

    Fast Cognitive Evaluation (FaCE) score range from 0 to 27. Higher score indicates better cognitive function.

  5. Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index

    Time frame: Baseline (T1), up to 18 months

    Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.

  6. Number of Days to Engraftment Measured From Infusion to Engraftment.

    Time frame: Up to 18 months

    To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.

  7. Number of Days of Hospitalization Measured From Admission to Engraftment.

    Time frame: Up to 18 months

    To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.

  8. Number of Hospital Readmissions After Hospital Discharge

    Time frame: Up to 100 days

    To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.

  9. Number of Infections From Hospital Admission

    Time frame: up to 100 Days Post-Infusion Day

    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.

  10. Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7)

    Time frame: Baseline (T1), up to 18 months

    Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.

  11. Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline (T1), up to 18 months

    PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.

  12. Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised

    Time frame: Baseline (T1), up to 18 months

    Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.

  13. Change in Serum Cortisol as Measured by ELISA

    Time frame: Baseline (T1), up to 18 months

    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

  14. Change in Immunocompetence as Measured by Cytokines

    Time frame: Baseline (T1), up to 18 months

    Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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