Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation

NCT ID: NCT05968963

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-06-01

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness-based Music Therapy (MBMT)

Participants will be in the MBMT group for 5 months.

Group Type EXPERIMENTAL

Mindfulness-based Music Therapy (MBMT)

Intervention Type 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)

Participants will be in the MM group for 5 months.

Group Type EXPERIMENTAL

Mindfulness Meditation (MM)

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-based Music Therapy (MBMT)

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.

Intervention Type BEHAVIORAL

Mindfulness Meditation (MM)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Frank Penedo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank J. Penedo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1R61CA263335-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20230726

Identifier Type: -

Identifier Source: org_study_id

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