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

NCT05968963 | Active Not Recruiting DMC

• 2 other identifiers: 202307261R61CA263335-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Count of Participants Recruited

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

  Baseline (T1)

• Number of Participants Retained

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

  Up to 18 months

• Mean Number of Intervention Sessions that Participants Completed

  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.

  Up to 100 days post-transplant

• Satisfaction Scores as Measured by Weekly Rating Satisfaction Score

  Scores per item range from 0 to 5. Higher scores indicate more satisfaction.

  Up to 100 days post-transplant

Secondary Outcomes (16)

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

  Baseline (T1), up to 18 months

• Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.

  Baseline (T1), up to 18 months

• Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.

  Baseline (T1), up to 18 months

• Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.

  Baseline (T1), up to 18 months

• Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index

  Baseline (T1), up to 18 months

Study Arms (2)

Mindfulness-based Music Therapy (MBMT)

EXPERIMENTAL

Participants will be in the MBMT group for 5 months.

Behavioral: Mindfulness-based Music Therapy (MBMT)

Mindfulness Meditation (MM)

EXPERIMENTAL

Participants will be in the MM group for 5 months.

Behavioral: Mindfulness Meditation (MM)

Interventions

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-based Music Therapy (MBMT)

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.

Mindfulness Meditation (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

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

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Frank J. Penedo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: November 28, 2023
• Primary Completion: May 26, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)