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Behavioral Intervention

Mindfulness-based Music Therapy for Stem Cell Transplantation

N/A
Recruiting
Led By Frank J. Penedo, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t1), up to 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a music therapy to improve quality of life and reduce symptoms in patients getting a stem cell transplant.

Who is the study for?
This trial is for English or Spanish speakers aged 18+ with myelodysplastic syndrome, acute myeloid leukemia, acute lymphoblastic leukemia, or non-Hodgkin's Lymphoma who are planning to undergo allogeneic stem cell transplantation. It excludes those with severe psychiatric issues, cognitive impairments, recent substance dependence, hearing problems, or recent mindfulness/music therapy participation.
What is being tested?
The study tests an electronic health mindfulness-based music therapy intervention aimed at improving life quality and reducing symptoms in patients undergoing allogeneic stem cell transplants. Participants will receive either Mindfulness Meditation (MM) or Mindfulness-based Music Therapy (MBMT).
What are the potential side effects?
Since the interventions involve meditation and music therapy rather than drugs or invasive procedures, significant side effects are not expected. However, participants may experience emotional discomfort due to the nature of mindfulness practices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t1), up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1), up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Count of Participants Recruited
Mean Number of Intervention Sessions that Participants Completed
Number of Participants Retained
+1 more
Secondary study objectives
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Change in Cognitive Function Scores as Measured by The Repeatable Battery for the Assessment of Neuropsychological Status.
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mindfulness-based Music Therapy (MBMT)Experimental Treatment1 Intervention
Participants will be in the MBMT group for 5 months.
Group II: Mindfulness Meditation (MM)Experimental Treatment1 Intervention
Participants will be in the MM group for 5 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Meditation (MM)
2021
N/A
~850

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,397 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,945 Total Patients Enrolled
Frank J. Penedo, PhDPrincipal InvestigatorUniversity of Miami

Media Library

Electronic Health Mindfulness-based Music Therapy Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05968963 — N/A
Lymphoblastic Leukemia-Lymphoma Research Study Groups: Mindfulness-based Music Therapy (MBMT), Mindfulness Meditation (MM)
Lymphoblastic Leukemia-Lymphoma Clinical Trial 2023: Electronic Health Mindfulness-based Music Therapy Intervention Highlights & Side Effects. Trial Name: NCT05968963 — N/A
Electronic Health Mindfulness-based Music Therapy Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968963 — N/A
~9 spots leftby Feb 2025
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