Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06286332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Therapy in Acute Leukemia Patients With Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-10', 'releaseDate': '2025-11-24'}, {'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21.', 'timeFrame': 'Baseline and Day 21.', 'description': 'The TFRS and NRS-11 is validated, self-reported instrument assessing average fatigue intensify.\n\nThe TFRS comprises a total of 37 items, encompassing 15 questions related to physiological aspects, 12 questions addressing psychosocial factors, and 10 questions focusing on daily living activities. The scoring system ranges from 1 to 10, with higher scores indicating a greater level of fatigue.\n\nNRS-11 scores range from 0 (no fatigue) to 10 (worst possible fatigue). Change = (Day 21 score - Baseline score).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in neutrophil, hemoglobin, abumin at day 21.', 'timeFrame': 'Baseline and Day 21.', 'description': 'The alterations in hematologic parameters, specifically white blood cell count, hemoglobin levels, and albumin levels, were assessed through blood samples collected at baseline and on the 21st day.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'Music', 'Fatigue'], 'conditions': ['Acute Myeloid Leukemia', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '33500864', 'type': 'BACKGROUND', 'citation': 'AlFayyad I, Al-Tannir M, Yaqub M, Heena H, AlMukaibil N, Ghazwani M, Abu-Shaheen A. Clinically Significant Fatigue in Adult Leukemia Patients: Prevalence, Predictors, and Impact on Quality of Life. Cureus. 2020 Dec 23;12(12):e12245. doi: 10.7759/cureus.12245.'}, {'pmid': '11839378', 'type': 'BACKGROUND', 'citation': 'Schumacher A, Wewers D, Heinecke A, Sauerland C, Koch OM, van de Loo J, Buchner T, Berdel WE. Fatigue as an important aspect of quality of life in patients with acute myeloid leukemia. Leuk Res. 2002 Apr;26(4):355-62. doi: 10.1016/s0145-2126(01)00145-x.'}, {'pmid': '34403772', 'type': 'BACKGROUND', 'citation': 'Rutkowski S, Czech O, Wrzeciono A, Kiper P, Szczepanska-Gieracha J, Malicka I. Virtual reality as a chemotherapy support in treatment of anxiety and fatigue in patients with cancer: A systematic review and meta-analysis and future research directions. Complement Ther Med. 2021 Sep;61:102767. doi: 10.1016/j.ctim.2021.102767. Epub 2021 Aug 14.'}, {'pmid': '35689676', 'type': 'RESULT', 'citation': 'Sezgin MG, Bektas H. The effect of music therapy interventions on fatigue in patients with hematological cancers: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2022 Nov;30(11):8733-8744. doi: 10.1007/s00520-022-07198-w. Epub 2022 Jun 11.'}, {'pmid': '17891547', 'type': 'RESULT', 'citation': 'Burns DS, Azzouz F, Sledge R, Rutledge C, Hincher K, Monahan PO, Cripe LD. Music imagery for adults with acute leukemia in protective environments: a feasibility study. Support Care Cancer. 2008 May;16(5):507-13. doi: 10.1007/s00520-007-0330-z. Epub 2007 Sep 22.'}, {'pmid': '14669295', 'type': 'RESULT', 'citation': 'Cassileth BR, Vickers AJ, Magill LA. Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cancer. 2003 Dec 15;98(12):2723-9. doi: 10.1002/cncr.11842.'}, {'pmid': '31038430', 'type': 'RESULT', 'citation': 'Reimnitz L, Silverman MJ. A randomized pilot study of music therapy in the form of patient-preferred live music on fatigue, energy and pain in hospitalized adult oncology patients on a blood and marrow transplant unit. Arts Health. 2020 Jun;12(2):154-168. doi: 10.1080/17533015.2018.1534251. Epub 2018 Oct 18.'}, {'pmid': '34077243', 'type': 'RESULT', 'citation': 'Miladinia M, Voss JG, Molavynejad S, Malehi AS, Zarea K, Nouri EM, Ahmadzadeh A. Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Nov;17(11):e1614-e1621. doi: 10.1200/OP.21.00156. Epub 2021 Jun 2.'}, {'pmid': '28533058', 'type': 'RESULT', 'citation': 'Bates D, Bolwell B, Majhail NS, Rybicki L, Yurch M, Abounader D, Kohuth J, Jarancik S, Koniarczyk H, McLellan L, Dabney J, Lawrence C, Gallagher L, Kalaycio M, Sobecks R, Dean R, Hill B, Pohlman B, Hamilton BK, Gerds AT, Jagadeesh D, Liu HD. Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study. Biol Blood Marrow Transplant. 2017 Sep;23(9):1567-1572. doi: 10.1016/j.bbmt.2017.05.015. Epub 2017 May 19.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.', 'detailedDescription': 'The researchers will explain the study objectives and methods, obtain informed consent, and have participants sign the consent form before commencing the study. Participants are randomly assigned to Group A and Group B. Participants in Group A undergo 30 minutes of self-selected music playback every day in addition to receiving standard therapy, while participants in Group B only receive standard therapy. The entire study duration spans 21 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with acute myeloid leukemia by a clinical specialist.\n2. Patients undergoing chemotherapy for the first time.\n3. Aged 18 years or older, capable of communicating in Mandarin or Taiwanese.\n4. Normal hearing ability.\n5. No history of psychiatric disorders and clear consciousness.\n6. Participants with no prior involvement in any intervention studies related to fatigue management.\n7. Demonstrates understanding of the research objectives, willingly participates in the study, and completes the informed consent form.\n8. Willing to cooperate with study procedures throughout the research period.\n\nExclusion Criteria:\n\n1. Severe hearing impairment.\n2. Individuals with unstable vital signs or altered consciousness.'}, 'identificationModule': {'nctId': 'NCT06286332', 'briefTitle': 'Music Therapy in Acute Leukemia Patients With Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'officialTitle': 'The Effectiveness of Music Therapy on Fatigue and Laboratory Values in Acute Leukemia Patients Undergoing Chemotherapy', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Therapy', 'description': 'Participants received self-selected music app playback for 30 minutes every day and standard therapy. The entire study duration spans 21 days.', 'interventionNames': ['Other: Music Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Participants only received standard care during the entire study duration span of 21 days.'}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': '30 minutes of self-selected music playback every day.', 'armGroupLabels': ['Music Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chien-Yu Wu, Bachelor', 'role': 'CONTACT', 'email': 'k.kathleenwu@gmail.com', 'phone': '886905126618'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Chien-Yu Wu', 'investigatorAffiliation': 'Chang Gung University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-24', 'type': 'RELEASE'}, {'date': '2025-12-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chien-Yu Wu, Nurse, Chang Gung University'}}}}