Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-03 @ 12:25 AM
Study NCT ID:
NCT06628167
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Support Program for Lung Cancer Screening Volume II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014186', 'term': 'Transportation'}, {'id': 'D001071', 'term': 'Appointments and Schedules'}], 'ancestors': [{'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-21', 'size': 113225, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-26T11:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the impact of the community support program in improving adherence to lung cancer screening follow-up', 'timeFrame': '6 months', 'description': "The study will measure the impact of a CSP on a population level by using aggregated neighborhood level data. The database has records of patients who had baseline LCS with individual level residential address geocoded to determine neighborhood. West Philadelphia planning district is the intervention group because it's within the catchment area of Penn Medicine, has the highest number of LCS patients, and has consistent high rates of smoking and lung cancer mortality. The control group is patients from Southwest Philadelphia planning district which has a similar Yost score: composite index of socioeconomic status.\n\nThe study will compare the rate of appointment attendance between West Philadelphia patients with scheduled/ordered LCS (intervention group), and appointment attendance of Southwest Philadelphia patients with scheduled/ordered LCS. The study will measure if there's a significant difference made by a CSP on a patient's likelihood of LCS attendance."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "This is a West Philadelphia based community project to improve adherence to lung cancer screening. The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improve adherence to LCS follow-up guidelines in an urban environment. The study will target individuals in the Penn Medicine healthcare system residing in Philadelphia with an upcoming or missed follow-up screening or orders placed but who have not yet scheduled their screenings by offering free transportation coordination to and from the appointment. The study team will also offer to connect those with placed but unscheduled low dose CT orders to connect with Penn Medicine's scheduling staff."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upcoming or missed low dose CT for lung cancer screening\n* Philadelphia resident\n\nExclusion Criteria:\n\n* Lives outside Philadelphia city limits'}, 'identificationModule': {'nctId': 'NCT06628167', 'acronym': 'LCS II', 'briefTitle': 'Community Support Program for Lung Cancer Screening Volume II', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Community Support Program for Lung Cancer Screening Volume II', 'orgStudyIdInfo': {'id': '08524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'West Philadelphia', 'description': 'Eligible patient population lives in West Philadelphia', 'interventionNames': ['Behavioral: Transportation', 'Behavioral: Scheduling']}, {'type': 'NO_INTERVENTION', 'label': 'Southwest Philadelphia', 'description': 'Eligible patient population lives in Southwest Philadelphia'}], 'interventions': [{'name': 'Transportation', 'type': 'BEHAVIORAL', 'description': 'Participants with ordered low dose CT and participants with scheduled low dose CT are offered free transportation to and from appointment. Participants with ordered low dose CT are also offered assistance in connecting with scheduling staff.', 'armGroupLabels': ['West Philadelphia']}, {'name': 'Scheduling', 'type': 'BEHAVIORAL', 'description': 'Participants with ordered low dose CT are offered assistance in connecting with scheduling staff.', 'armGroupLabels': ['West Philadelphia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farouk Dako, MD, MPH', 'role': 'CONTACT', 'email': 'farouk.dako@pennmedicine.upenn.edu', 'phone': '267-309-1241'}, {'name': 'James Seward', 'role': 'CONTACT', 'email': 'james.seward@pennmedicine.upenn.edu', 'phone': '2156153388'}], 'facility': 'Univeristy of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Farouk Dako', 'role': 'CONTACT', 'email': 'farouk.dako@pennmedicine.upenn.edu', 'phone': '2673091241'}, {'name': 'Caroline Rosen', 'role': 'CONTACT', 'email': 'caroline.rosen@pennmedicine.upenn.edu'}], 'overallOfficials': [{'name': 'Farouk Dako, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'farouk.dako@pennmedicine.upenn.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}