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Not yet recruiting NCT07469592

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

No phase Interventional Stem Cell Transplantation Myelodysplastic Syndromes Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eHealth Mindfulness-based Music Therapy (eMBMT), eHealth Mindfulness Meditation (eMM).
Who it may be relevant to
Registry conditions: Stem Cell Transplantation, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07469592 · 20250732 · R33CA263335

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗