Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT

January 23, 2023 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Effects of Music Therapy in Controlling Symptoms in Patients With Acute Myeloblastic Leukemia and Undergoing Hematopoietic Stem Cell Transplantation: a Randomized Controlled Clinical Trial

The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are:

- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?

Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session.

Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Instituto Investigacion Sanitaria Fundacion Jimenez Diaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years old.
  • Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).
  • Patients undergoing autologous or allogeneic stem cell transplantation.
  • Being able to understand and read Spanish properly.
  • Basic computer skills.

Exclusion Criteria:

  • Moderate-severe hearing impairment (unilateral or bilateral).
  • Past history of psychiatric disorders.
  • Performance status: ECOG ≥ 3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AML-E
Acute myeloblastic leukemia - experimental
Behavioral: Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
No Intervention: AML-C
Acute myeloblastic leukemia - control
Experimental: AlloSCT-E
Allogeneic stem cell transplantation - experimental
Behavioral: Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
No Intervention: AlloSCT-C
Allogeneic stem cell transplantation - control
Experimental: AutoSCT-E(I)
Autologous stem cell transplantation - experimental (inpatient)
Behavioral: Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
No Intervention: AutoSCT-C(I)
Autologous stem cell transplantation - control (inpatient)
Experimental: AutoSCT-E(O)
Autologous stem cell transplantation - experimental (outpatient)
Behavioral: Passive music therapy
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
No Intervention: AutoSCT-C(O)
Autologous stem cell transplantation - control (outpatient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical and psychological symptom burden
Time Frame: The ESAS global score is measured before and after the daily music therapy session (from date of randomization until the date of discharge, up to 8 weeks)
Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)
The ESAS global score is measured before and after the daily music therapy session (from date of randomization until the date of discharge, up to 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score
Time Frame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
HADS score (0 to 42 points, higher scores mean higher anxiety/depression)
Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score
Time Frame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
FACT-G score (0 to 108 points, higher scores mean better quality of life)
Once a week (from date of randomization until the date of discharge, up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

  • Principal Investigator: Alberto Lázaro García, MD, Fundacion Jimenez Diaz University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC086-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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