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

Study Overview
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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.

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

Conditions
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Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Behavioral: Passive music therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control