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

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)

Overall Status

Completed

CT.gov ID

NCT05696457

Collaborator

(none)

Enrollment

Location

Arms

21.6

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloblastic Leukemia Hematopoietic Stem Cell Transplantation	Behavioral: Passive music therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled clinical trialRandomized controlled clinical trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Nov 21, 2022

Actual Study Completion Date :

Nov 21, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Change in physical and psychological 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)]
Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)

Secondary Outcome Measures

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)]
HADS score (0 to 42 points, higher scores mean higher anxiety/depression)
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)]
FACT-G score (0 to 108 points, higher scores mean better quality of life)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.