Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 11:18 AM
Study NCT ID:
NCT04969367
Status:
WITHDRAWN
Last Update Posted:
2025-04-29
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-11', 'size': 578069, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-11T21:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Staffing', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accrual rate', 'timeFrame': 'Up to 90 days', 'description': 'accrual rate will be measured by counting subjects'}, {'measure': 'Acceptability', 'timeFrame': 'Up to 90 days', 'description': 'Acceptability will be measured by a short survey'}, {'measure': 'compliance with device', 'timeFrame': 'Up to 90 days', 'description': 'compliance with device (80% of the 90-day intervention time)'}, {'measure': 'retention rate', 'timeFrame': 'Up to 90 days', 'description': 'retention rate of subjects will be measured by counting at 90 days'}, {'measure': 'Acceptability', 'timeFrame': 'Up to 90 days', 'description': 'Acceptability will be measured by an interview addressing participant satisfaction'}], 'secondaryOutcomes': [{'measure': 'Daily step count', 'timeFrame': 'Up to 90 days', 'description': 'Daily step count'}, {'measure': 'Average daily resting heart rate', 'timeFrame': 'Up to 90 days', 'description': 'average daily resting heart rate'}, {'measure': 'Fact-An score (assessed twice a week),', 'timeFrame': 'Up to 90 days', 'description': 'Fact-An score (assessed twice a week),'}, {'measure': 'Hemoglobin level measured by CBC twice a week', 'timeFrame': 'Up to 90 days', 'description': 'Hemoglobin level measured by CBC twice a week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.', 'detailedDescription': 'This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed pathologic diagnosis of MDS\n* Requiring \\>= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =\\< 8 g/dL if newly diagnosed\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable)\n* Able to give informed consent\n* Willing to comply with all study procedures and available for the duration of the study\n* Able to read and/or understand English\n* Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device\n* Have access to Bluetooth low energy (LE) and internet connection for syncing\n\nExclusion Criteria:\n\n• Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT04969367', 'briefTitle': 'Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': '21D.214'}, 'secondaryIdInfos': [{'id': 'JT 16333', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (activity monitor)', 'description': 'Patients wear an activity monitor (Fitbit) for 90 days. Patients also undergo collection of blood samples and complete questionnaires twice weekly for up to 90 days.', 'interventionNames': ['Other: Medical Device Usage and Evaluation', 'Procedure: Biospecimen Collection', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear activity monitor (Fitbit)', 'armGroupLabels': ['Observational (activity monitor)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of blood samples', 'armGroupLabels': ['Observational (activity monitor)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (activity monitor)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (activity monitor)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}