Acute Myeloblastic LeukemiaNCT05696457
Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT
A study testing Passive music therapy in people with Acute Myeloblastic Leukemia and Hematopoietic Stem Cell Transplantation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Passive music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- Moderate-severe hearing impairment (unilateral or bilateral).
- Past history of psychiatric disorders.
- Performance status: ECOG ≥ 3.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Madrid, 28040
About this study
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
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?
Read more
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.
- Being tested
- Passive music therapy
- Keywords
- Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive music therapyBehavioural
Patients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion.
| Study group | Role | What they receive |
|---|---|---|
| AML-E | Experimental | Acute myeloblastic leukemia - experimental Receives: Behavioral: Passive music therapy |
| AML-C | No intervention | Acute myeloblastic leukemia - control |
| AlloSCT-E | Experimental | Allogeneic stem cell transplantation - experimental Receives: Behavioral: Passive music therapy |
| AlloSCT-C | No intervention | Allogeneic stem cell transplantation - control |
| AutoSCT-E(I) | Experimental | Autologous stem cell transplantation - experimental (inpatient) Receives: Behavioral: Passive music therapy |
| AutoSCT-C(I) | No intervention | Autologous stem cell transplantation - control (inpatient) |
| AutoSCT-E(O) | Experimental | Autologous stem cell transplantation - experimental (outpatient) Receives: Behavioral: Passive music therapy |
| AutoSCT-C(O) | No intervention | Autologous stem cell transplantation - control (outpatient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical and psychological symptom burden
Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)
Measured: 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 (2)
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)
Measured: 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
FACT-G score (0 to 108 points, higher scores mean better quality of life)
Measured: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Feb 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Lázaro García, MD, Principal investigator, Fundación Jiménez Díaz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696457
- Sponsor's protocol ID
- EC086-20
- Status last verified
- Jan 2023
- First submitted
- 24 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38447622
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05696457
- Acronym / sponsor ID
- EC086-20
- Keywords
- Acute Myeloblastic Leukemia, Hematopoietic Stem Cell Transplantation, Music therapy, Symptom control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| AML-E | Experimental | Behavioral: Passive music therapyAcute myeloblastic leukemia - experimental |
| AML-C | No intervention | –Acute myeloblastic leukemia - control |
| AlloSCT-E | Experimental | Behavioral: Passive music therapyAllogeneic stem cell transplantation - experimental |
| AlloSCT-C | No intervention | –Allogeneic stem cell transplantation - control |
| AutoSCT-E(I) | Experimental | Behavioral: Passive music therapyAutologous stem cell transplantation - experimental (inpatient) |
| AutoSCT-C(I) | No intervention | –Autologous stem cell transplantation - control (inpatient) |
| AutoSCT-E(O) | Experimental | Behavioral: Passive music therapyAutologous stem cell transplantation - experimental (outpatient) |
| AutoSCT-C(O) | No intervention | –Autologous stem cell transplantation - control (outpatient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (3 listed)
- Moderate-severe hearing impairment (unilateral or bilateral).
- Past history of psychiatric disorders.
- Performance status: ECOG ≥ 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive music therapyPatients included in the experimental group receive a 25 min passive music therapy session on a daily basis, which changes depending on their emotion. | Behavioural | AML-E, AlloSCT-E, AutoSCT-E(I), AutoSCT-E(O) |
Primary outcome
Change in physical and psychological 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)
Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)
2 secondary outcomes
Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score
Time frame: 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
Time frame: Once a week (from date of randomization until the date of discharge, up to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 38447622Lazaro-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Lázaro García, MD principal investigator
Fundación Jiménez Díaz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive music therapy in people with Acute Myeloblastic Leukemia and Hematopoietic Stem Cell Transplantation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical and psychological 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.