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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

Study 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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t1), up to 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Count of Participants Recruited

Mean Number of Intervention Sessions that Participants Completed

Number of Participants Retained

+1 more

Secondary outcome measures

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

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)

2018

N/A

~520

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,016 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,742 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

Acute Myeloid Leukemia Research Study Groups: Mindfulness-based Music Therapy (MBMT), Mindfulness Meditation (MM)

Acute Myeloid Leukemia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this clinical research currently available for individuals?

"Current data on clinicaltrials.gov indicates that this study is not actively enrolling patients, despite having been initially posted September 1st 2023 and last updated August 1st 2023. Fortunately for those seeking to participate in a medical trial, there are 3,049 other studies recruiting at present."

Answered by AI

What aims are researchers expecting to achieve from this clinical trial?

"The primary aim of this clinical trial, which will be monitored from baseline (T1) is to track the number of participants retained. Secondary objectives involve evaluating patient-reported outcome measures such as PROMIS® Pain Scale (range 3 - 15; higher scores signify greater pain), PROMIS® Fatigue Scale (Range 8 - 40; higher values indicate more exhaustion), and RBANS Scores (Range 40 - 160 with better cognitive function corresponding to larger numbers)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Frank Penedo 2023. "Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968963.

All > Acute Lymphocytic Leukemia > Aml