Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control
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.
Interventions
BEHAVIORALPassive 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.
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Spain
Outcome results
None listed