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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz71 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Myeloblastic Leukemia Hematopoietic Stem Cell Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in physical and psychological symptom burden

Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher 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)

Secondary Outcomes

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)

Time frame: 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)