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

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplantation; Acute Myeloblastic Leukemia
• Interventions: Behavioral: Passive music therapy

• Registration Number: NCT05696457
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Study First Submitted: 2022-11-24
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AutoSCT-E(O)	Passive music therapy	Autologous stem cell transplantation - experimental (outpatient)
AutoSCT-E(I)	Passive music therapy	Autologous stem cell transplantation - experimental (inpatient)
AML-E	Passive music therapy	Acute myeloblastic leukemia - experimental
AlloSCT-E	Passive music therapy	Allogeneic stem cell transplantation - experimental

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Instituto Investigacion Sanitaria Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain