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

University of Miami logo

University of Miami

Status

Enrolling

Conditions

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

Treatments

Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT)
Behavioral: eHealth Mindfulness Meditation (eMM)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07469592
R33CA263335 (U.S. NIH Grant/Contract)
20250732

Details and patient eligibility

About

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.

Enrollment

165 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

165 participants in 2 patient groups

eHealth Mindfulness-based Music Therapy (eMBMT)
Experimental group
Description:
Participants will be in the MBMT group for 5 months.
Treatment:
Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT)
eHealth Mindfulness Meditation (eMM)
Experimental group
Description:
Participants will be in the MM group for 5 months.
Treatment:
Behavioral: eHealth Mindfulness Meditation (eMM)

Trial contacts and locations

1

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Central trial contact

Sara E Fleszar-Pavlovic, PhD; Frank J Penedo, PhD

Data sourced from clinicaltrials.gov

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