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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML-E | Experimental | Acute myeloblastic leukemia - experimental |
|
| AML-C | No Intervention | Acute myeloblastic leukemia - control | |
| AlloSCT-E | Experimental | Allogeneic stem cell transplantation - experimental |
|
| AlloSCT-C | No Intervention | Allogeneic stem cell transplantation - control | |
| AutoSCT-E(I) | Experimental | Autologous stem cell transplantation - experimental (inpatient) |
|
| AutoSCT-C(I) | No Intervention | Autologous stem cell transplantation - control (inpatient) | |
| AutoSCT-E(O) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive music therapy | Behavioral | Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical and psychological symptom burden | Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Once a week (from date of randomization until the date of discharge, up to 8 weeks) |
| Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Lázaro GarcÃa, MD | Fundación Jiménez DÃaz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Investigacion Sanitaria Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38447622 | Derived | Lazaro-Garcia A, Lainez-Gonzalez D, Gonzalez-Rodriguez M, Cano Alsua S, Suarez M EU, Solan-Blanco L, Cornago-Navascues J, Lopez-Lorenzo JL, Llamas-Sillero P, Alonso-Dominguez JM. Music Listening in Stem Cell Transplantation and Acute Myeloid Leukemia: A Randomized Clinical Trial. J Pain Symptom Manage. 2024 Jun;67(6):501-511.e12. doi: 10.1016/j.jpainsymman.2024.02.567. Epub 2024 Mar 4. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Randomized controlled clinical trial
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Autologous stem cell transplantation - experimental (outpatient) |
|
| AutoSCT-C(O) | No Intervention | Autologous stem cell transplantation - control (outpatient) |
FACT-G score (0 to 108 points, higher scores mean better quality of life) |
| Once a week (from date of randomization until the date of discharge, up to 8 weeks) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |