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

NCT ID: NCT05696457

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-11-21

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloblastic Leukemia Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AML-E

Acute myeloblastic leukemia - experimental

Group Type EXPERIMENTAL

Passive music therapy

Intervention Type BEHAVIORAL

Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.

AML-C

Acute myeloblastic leukemia - control

Group Type NO_INTERVENTION

No interventions assigned to this group

AlloSCT-E

Allogeneic stem cell transplantation - experimental

Group Type EXPERIMENTAL

Passive music therapy

Intervention Type BEHAVIORAL

Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.

AlloSCT-C

Allogeneic stem cell transplantation - control

Group Type NO_INTERVENTION

No interventions assigned to this group

AutoSCT-E(I)

Autologous stem cell transplantation - experimental (inpatient)

Group Type EXPERIMENTAL

Passive music therapy

Intervention Type BEHAVIORAL

Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.

AutoSCT-C(I)

Autologous stem cell transplantation - control (inpatient)

Group Type NO_INTERVENTION

No interventions assigned to this group

AutoSCT-E(O)

Autologous stem cell transplantation - experimental (outpatient)

Group Type EXPERIMENTAL

Passive music therapy

Intervention Type BEHAVIORAL

Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.

AutoSCT-C(O)

Autologous stem cell transplantation - control (outpatient)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Lázaro García, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Jiménez Díaz University Hospital

Locations

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Instituto Investigacion Sanitaria Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 38447622 (View on PubMed)

Other Identifiers

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EC086-20

Identifier Type: -

Identifier Source: org_study_id

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