Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:04 AM
Study NCT ID:
NCT07469592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)'}, {'measure': 'Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': '(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.'}, {'measure': 'Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': '(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.'}, {'measure': 'Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.'}, {'measure': 'Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.'}, {'measure': 'Number of Days to Engraftment Measured from Infusion to Engraftment.', 'timeFrame': 'Up to 18 months', 'description': 'To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.'}, {'measure': 'Number of Days of Hospitalization Measured from Admission to Engraftment.', 'timeFrame': 'Up to 18 months', 'description': 'To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.'}, {'measure': 'Number of Hospital Readmissions after Hospital Discharge', 'timeFrame': 'Up to 100 days', 'description': 'To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.'}, {'measure': 'Number of Infections from Hospital Admission', 'timeFrame': 'up to 100 Days Post-Infusion Day', 'description': 'To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.'}, {'measure': 'Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.'}, {'measure': 'Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.'}, {'measure': 'Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.'}, {'measure': 'Change in Serum Cortisol as Measured by ELISA', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation'}, {'measure': 'Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a \\>3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.'}, {'measure': 'Change in Immunocompetence as Measured by Thymic Function', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.'}, {'measure': 'Change in Immunocompetence as Measured by Regulatory T cells', 'timeFrame': 'Baseline (T1), up to 18 months', 'description': 'Regulatory T cells measured as cells/mm\\^3'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stem Cell Transplantation', 'Myelodysplastic Syndromes', 'Leukemia, Myeloid, Acute', 'Precursor Cell Lymphoblastic Leukemia-Lymphoma', 'Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years of age\n* have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \\[MDS\\], acute myeloid leukemia \\[AML\\], acute lymphoblastic leukemia \\[ALL\\], or non Hodgkin's Lymphoma \\[NHL\\])\n* have a treatment plan for a hematopoietic stem cell transplant\n* Speak English or Spanish\n\nExclusion Criteria:\n\n* history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)\n* severe cognitive impairment (per the short portable mental status questionnaire)\n* hearing impairment\n* active alcohol or substance dependence within the past six months\n* participated in the prior pilot MBMT R61 phase\n* participated in music therapy or mindfulness programs in the past six months"}, 'identificationModule': {'nctId': 'NCT07469592', 'briefTitle': 'eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '20250732'}, 'secondaryIdInfos': [{'id': 'R33CA263335', 'link': 'https://reporter.nih.gov/quickSearch/R33CA263335', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eHealth Mindfulness-based Music Therapy (eMBMT)', 'description': 'Participants will be in the MBMT group for 5 months.', 'interventionNames': ['Behavioral: eHealth Mindfulness-based Music Therapy (eMBMT)']}, {'type': 'EXPERIMENTAL', 'label': 'eHealth Mindfulness Meditation (eMM)', 'description': 'Participants will be in the MM group for 5 months.', 'interventionNames': ['Behavioral: eHealth Mindfulness Meditation (eMM)']}], 'interventions': [{'name': 'eHealth Mindfulness-based Music Therapy (eMBMT)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.', 'armGroupLabels': ['eHealth Mindfulness-based Music Therapy (eMBMT)']}, {'name': 'eHealth Mindfulness Meditation (eMM)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.', 'armGroupLabels': ['eHealth Mindfulness Meditation (eMM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Juan Caffroni', 'role': 'CONTACT', 'email': 'jcc281@med.miami.edu', 'phone': '305-243-4445'}, {'name': 'Frank J Penedo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Frank J Penedo, PhD', 'role': 'CONTACT', 'email': 'fpenedo@miami.edu', 'phone': '(305) 284-4290'}, {'name': 'Sara E Fleszar-Pavlovic, PhD', 'role': 'CONTACT', 'email': 'sarafleszarpavlovic@med.miami.edu', 'phone': '(305) 243-4009'}], 'overallOfficials': [{'name': 'Frank J Penedo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Frank Penedo', 'investigatorAffiliation': 'University of Miami'}}}}