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

Primary Purpose

Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Passive music therapy
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloblastic Leukemia focused on measuring Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: Moderate-severe hearing impairment (unilateral or bilateral). Past history of psychiatric disorders. Performance status: ECOG ≥ 3.

Sites / Locations

  • Instituto Investigacion Sanitaria Fundacion Jimenez Diaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

AML-E

AML-C

AlloSCT-E

AlloSCT-C

AutoSCT-E(I)

AutoSCT-C(I)

AutoSCT-E(O)

AutoSCT-C(O)

Arm Description

Acute myeloblastic leukemia - experimental

Acute myeloblastic leukemia - control

Allogeneic stem cell transplantation - experimental

Allogeneic stem cell transplantation - control

Autologous stem cell transplantation - experimental (inpatient)

Autologous stem cell transplantation - control (inpatient)

Autologous stem cell transplantation - experimental (outpatient)

Autologous stem cell transplantation - control (outpatient)

Outcomes

Primary Outcome Measures

Change in physical and psychological symptom burden
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
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
FACT-G score (0 to 108 points, higher scores mean better quality of life)

Full Information

First Posted
November 24, 2022
Last Updated
January 23, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT05696457
Brief Title
Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation
Keywords
Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AML-E
Arm Type
Experimental
Arm Description
Acute myeloblastic leukemia - experimental
Arm Title
AML-C
Arm Type
No Intervention
Arm Description
Acute myeloblastic leukemia - control
Arm Title
AlloSCT-E
Arm Type
Experimental
Arm Description
Allogeneic stem cell transplantation - experimental
Arm Title
AlloSCT-C
Arm Type
No Intervention
Arm Description
Allogeneic stem cell transplantation - control
Arm Title
AutoSCT-E(I)
Arm Type
Experimental
Arm Description
Autologous stem cell transplantation - experimental (inpatient)
Arm Title
AutoSCT-C(I)
Arm Type
No Intervention
Arm Description
Autologous stem cell transplantation - control (inpatient)
Arm Title
AutoSCT-E(O)
Arm Type
Experimental
Arm Description
Autologous stem cell transplantation - experimental (outpatient)
Arm Title
AutoSCT-C(O)
Arm Type
No Intervention
Arm Description
Autologous stem cell transplantation - control (outpatient)
Intervention Type
Behavioral
Intervention Name(s)
Passive music therapy
Intervention Description
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
Primary Outcome Measure Information:
Title
Change in physical and psychological symptom burden
Description
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 Outcome Measure Information:
Title
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score
Description
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)
Title
Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score
Description
FACT-G score (0 to 108 points, higher scores mean better quality of life)
Time Frame
Once a week (from date of randomization until the date of discharge, up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Lázaro García, MD
Organizational Affiliation
Fundación Jiménez Díaz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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