Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 4:59 PM
Study NCT ID:
NCT05696457
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2022-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)'}], 'secondaryOutcomes': [{'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)', 'description': 'HADS score (0 to 42 points, higher scores mean higher anxiety/depression)'}, {'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)', 'description': 'FACT-G score (0 to 108 points, higher scores mean better quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloblastic Leukemia', 'Hematopoietic Stem Cell Transplantation', 'Music therapy', 'Symptom control'], 'conditions': ['Acute Myeloblastic Leukemia', 'Hematopoietic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '38447622', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n\\- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?\n\nParticipants 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.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old.\n* Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).\n* Patients undergoing autologous or allogeneic stem cell transplantation.\n* Being able to understand and read Spanish properly.\n* Basic computer skills.\n\nExclusion Criteria:\n\n* Moderate-severe hearing impairment (unilateral or bilateral).\n* Past history of psychiatric disorders.\n* Performance status: ECOG ≥ 3.'}, 'identificationModule': {'nctId': 'NCT05696457', 'briefTitle': 'Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Effects of Music Therapy in Controlling Symptoms in Patients With Acute Myeloblastic Leukemia and Undergoing Hematopoietic Stem Cell Transplantation: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'EC086-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AML-E', 'description': 'Acute myeloblastic leukemia - experimental', 'interventionNames': ['Behavioral: Passive music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'AML-C', 'description': 'Acute myeloblastic leukemia - control'}, {'type': 'EXPERIMENTAL', 'label': 'AlloSCT-E', 'description': 'Allogeneic stem cell transplantation - experimental', 'interventionNames': ['Behavioral: Passive music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'AlloSCT-C', 'description': 'Allogeneic stem cell transplantation - control'}, {'type': 'EXPERIMENTAL', 'label': 'AutoSCT-E(I)', 'description': 'Autologous stem cell transplantation - experimental (inpatient)', 'interventionNames': ['Behavioral: Passive music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'AutoSCT-C(I)', 'description': 'Autologous stem cell transplantation - control (inpatient)'}, {'type': 'EXPERIMENTAL', 'label': 'AutoSCT-E(O)', 'description': 'Autologous stem cell transplantation - experimental (outpatient)', 'interventionNames': ['Behavioral: Passive music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'AutoSCT-C(O)', 'description': 'Autologous stem cell transplantation - control (outpatient)'}], 'interventions': [{'name': 'Passive music therapy', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['AML-E', 'AlloSCT-E', 'AutoSCT-E(I)', 'AutoSCT-E(O)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Instituto Investigacion Sanitaria Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Alberto Lázaro García, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación Jiménez Díaz University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}