Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT
1 other identifier
interventional
71
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2022
CompletedFirst Submitted
Initial submission to the registry
November 24, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedJanuary 25, 2023
January 1, 2023
1.8 years
November 24, 2022
January 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in physical and psychological symptom burden
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 Outcomes (2)
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score
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
Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Study Arms (8)
AML-E
EXPERIMENTALAcute myeloblastic leukemia - experimental
AML-C
NO INTERVENTIONAcute myeloblastic leukemia - control
AlloSCT-E
EXPERIMENTALAllogeneic stem cell transplantation - experimental
AlloSCT-C
NO INTERVENTIONAllogeneic stem cell transplantation - control
AutoSCT-E(I)
EXPERIMENTALAutologous stem cell transplantation - experimental (inpatient)
AutoSCT-C(I)
NO INTERVENTIONAutologous stem cell transplantation - control (inpatient)
AutoSCT-E(O)
EXPERIMENTALAutologous stem cell transplantation - experimental (outpatient)
AutoSCT-C(O)
NO INTERVENTIONAutologous stem cell transplantation - control (outpatient)
Interventions
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- Moderate-severe hearing impairment (unilateral or bilateral).
- Past history of psychiatric disorders.
- Performance status: ECOG ≥ 3.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Madrid, 28040, Spain
Related Publications (1)
Lazaro-Garcia A, Lainez-Gonzalez D, Gonzalez-Rodriguez M, Cano Alsua S, Suarez M EU, Solan-Blanco L, Cornago-Navascues J, Lopez-Lorenzo JL, Llamas-Sillero P, Alonso-Dominguez JM. Music Listening in Stem Cell Transplantation and Acute Myeloid Leukemia: A Randomized Clinical Trial. J Pain Symptom Manage. 2024 Jun;67(6):501-511.e12. doi: 10.1016/j.jpainsymman.2024.02.567. Epub 2024 Mar 4.
PMID: 38447622DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Lázaro García, MD
Fundación Jiménez Díaz University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2022
First Posted
January 25, 2023
Study Start
February 1, 2021
Primary Completion
November 21, 2022
Study Completion
November 21, 2022
Last Updated
January 25, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share