Clinical trial NCT05696457: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloblastic Leukemia
Hematopoietic Stem Cell Transplantation
Keywords: Acute Myeloblastic Leukemia
Hematopoietic Stem Cell Transplantation
Music therapy
Symptom control
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in physical and psychological symptom burden
timeFrame: 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:
measure: Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
measure: Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score
timeFrame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Study officials:
affiliation: Fundación Jiménez Díaz University Hospital
name: Alberto Lázaro García, MD
role: PRINCIPAL_INVESTIGATOR
References: