Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07375992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will assess the feasibility of Music Therapy in the high-risk, high-needs population of individuals newly diagnosed with GBM and undergoing standard of care adjuvant chemotherapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of Music Therapy intervention for GBM patients', 'timeFrame': '6 months', 'description': 'Determine success rate of the delivery of individualized virtual music therapy (MT) in participants undergoing standard of care treatment for newly diagnosed glioblastoma.'}], 'secondaryOutcomes': [{'measure': 'Rate of survey completion', 'timeFrame': '2 years', 'description': 'Rate of participants completing all surveys.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newly diagnosed', 'Glioblastoma', 'Music Therapy'], 'conditions': ['Feasibility Studies']}, 'descriptionModule': {'briefSummary': 'The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.', 'detailedDescription': 'Virtually via Zoom, all participants will meet with Music Therapists to create playlists and learn how to complete surveys measuring quality of life.\n\nParticipants will be randomly assigned, half to each arm. Arm A will interact with Music Therapists and listen to music twice a week, then independently fill out quality of life questionnaires.\n\nArm B will listen to music independently twice a week, then independently fill out quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glioblastoma\n* Cognitive capacity to respond to surveys\n* Access to computer and web access\n* Ability to attend virtual music therapy sessions\n* Audibly process music\n* Proficient in English\n\nExclusion Criteria:\n\n* Not planning to undergo standard of care radiation therapy and concurrent and adjuvant temozolomide.\n* A life expectancy of less than 6 months.\n* Concurrent use of any other standard or investigational agents (excepting tumor treating fields).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit adherence with study requirements.'}, 'identificationModule': {'nctId': 'NCT07375992', 'acronym': 'MELODY', 'briefTitle': 'Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556', 'orgStudyIdInfo': {'id': 'J2556'}, 'secondaryIdInfos': [{'id': 'IRB00493841', 'type': 'OTHER', 'domain': 'JHU IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A- with Music Therapists', 'description': 'Arm A of the study will involve individuals who are assigned to receive twice weekly music therapy sessions with a Music Therapist. These live sessions will be conducted virtually via a Johns Hopkins Compliance virtual platform (e.g., Zoom) each session will last 30 minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.', 'interventionNames': ['Other: Music intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B- without Music Therapists', 'description': 'Arm B of the study participants will meet with a music therapist to create a curated playlist. The participant will then listen independently to music therapy sessions twice a week for thirty minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.', 'interventionNames': ['Other: Music intervention']}], 'interventions': [{'name': 'Music intervention', 'type': 'OTHER', 'description': "Each GBM study participant in Arm A will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be curated by a board-certified music therapist. Arm B participants will receive curated playlists of music created by a music therapist. Participants will then listen to the curated music playlists on the participant's own device twice per week.\n\nAll participants will complete a total of 16 music therapy sessions, scheduled twice per week over 8 weeks. Each session will last approximately 30 minutes.", 'armGroupLabels': ['Arm A- with Music Therapists', 'Arm B- without Music Therapists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'oncology- Broadway', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Principal Investigator, MD', 'role': 'CONTACT', 'email': 'bcp-iss@jh.edu', 'phone': '410-995-8837', 'phoneExt': '410-955-8837'}], 'overallOfficials': [{'name': 'Matthias Holdhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins -Sidney Kimmel Cancer Center'}, {'name': 'Grace Tobin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Keep Punching Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}