Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT07222358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "A one-time blood sample (30 mL) will be collected from each participant either at home or at a local facility. The sample will include clinical laboratory tests such as Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), lipids, HbA1c, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). The remaining portion of the sample will be banked at St. Jude Children's Research Hospital for future research.\n\nRetained blood samples may contain DNA and could be used for future genetic or molecular analyses."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-10-27', 'studyFirstSubmitQcDate': '2025-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation rate', 'timeFrame': 'Assessed at contact for enrollment of each participant (baseline/screening).', 'description': 'The proportion of eligible survivors approached who enroll in the intervention'}, {'measure': 'On-boarding rate', 'timeFrame': 'Baseline at study entry through week 12', 'description': 'The proportion of consented participants who successful onboard with the vendor and contribute any study data beyond baseline'}, {'measure': 'Completion rate', 'timeFrame': 'Baseline at study entry through week 12', 'description': 'The proportion of enrolled survivors who remain on study and complete both baseline and week 12/end of study assessments.'}, {'measure': 'Adherence to the remote monitoring intervention', 'timeFrame': 'Baseline at study entry through week 12', 'description': 'The proportion of enrolled survivors who complete at least 2/3 of the pre-specified remote monitoring study components'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['St. Jude Alumni', 'St. Jude Life Participants'], 'conditions': ['Childhood Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'This feasibility study evaluates a 12-week, multi-component remote assessment program for adult survivors of childhood cancer. The study aims to determine the participation and adherence rates to remote monitoring of cardiometabolic health using wearable devices, surveys, and laboratory testing facilitated by a third-party vendor.\n\nPrimary Objective - To establish the feasibility of a multi-component remote assessment program for adult survivors.\n\n* The primary outcome for feasibility will be the participation rate (# eligible survivors approached who enroll) and completion rate (# of eligible survivors who enroll and remain on study through completion).\n* An additional outcome for feasibility will be adherence to the multicomponent remote assessment among participants.\n\nSecondary Objective\n\n* To estimate the proportion of participants who complete each individual study component (adherence to each individual component monitoring).', 'detailedDescription': 'Survivors of childhood cancer face increased risks of late effects, including cardiometabolic conditions. Due to geographic diversity and mobility limitations, remote research participation is essential. This study pilots a remote assessment platform to monitor cardiometabolic health indicators such as blood pressure, heart rate variability, glucose control, physical activity, sleep, diet, and laboratory biomarkers. Participants will be on-boarded by a vendor, receive devices, and complete assessments remotely. A subset will participate in interviews to evaluate platform acceptability and barriers. The study will assess feasibility through participation and adherence rates, aiming to inform future remote intervention trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants who meet eligibility criteria and consent to enrollment on the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is ≥18 years of age\n* Participant is enrolled in the St. Jude Life (SJLIFE) cohort\n* Participant is able and willing to provide informed consent\n* Participant has signed a separate consent for the St. Jude banking protocol (TBANK)\n* Participant received anthracycline (≥100 mg/m²), chest or abdominal radiation as part of childhood cancer treatment\n* Participant owns a SmartPhone compatible with the vendor platform, Apple HealthKit, and Dexcom (a wearable device that continuously tracks glucose levels)\n* Participant verbalizes understanding directions for completing remote study activities with the third-party partner\n* Participant is fluent in English\n\nExclusion Criteria:\n\n* Participant uses a continuous glucose monitor for diabetes management or has diabetes requiring insulin or more than 1 agent for treatment at baseline\n* Participant is currently enrolled on an intervention or active longitudinal monitoring ancillary study'}, 'identificationModule': {'nctId': 'NCT07222358', 'briefTitle': 'Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery', 'orgStudyIdInfo': {'id': 'RAIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remote Monitoring Group', 'description': 'Participants will undergo a 12-week remote monitoring program using wearable devices and complete surveys and a one-time lab draw. A subset will participate in interviews post-intervention.', 'interventionNames': ['Behavioral: Remote Monitoring Program']}], 'interventions': [{'name': 'Remote Monitoring Program', 'type': 'BEHAVIORAL', 'description': '* Participants receive devices (Apple Watch, blood pressure monitor, Continuous Glucose Monitor (CGM), scale, measuring tape).\n* Monitoring includes ECG, blood pressure, glucose, weight, waist circumference, physical activity, and sleep.\n* Surveys include health status, medication use, personality traits, and acceptability measures.\n* One-time blood draw includes CBC, CMP, lipids, HbA1c, NT-proBNP\n* Food logging during CGM use.\n* Semi-structured interviews post-study for a subset.', 'armGroupLabels': ['Remote Monitoring Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Stephanie Dixon, MD, MPH', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}, {'name': 'Stephanie E Dixon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Stephanie Dixon, MD, MPH', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'overallOfficials': [{'name': 'Stephanie E Dixon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}