Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT06207435
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2023-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Community Support Program for Lung Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}], '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'}], 'ancestors': [{'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'farouk.dako@pennmedicine.upenn.edu', 'phone': '2673091241', 'title': 'Dr. Farouk Dako', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': "Adverse events were not assessed. The only intervention provided was optional transportation for a clinical scan already scheduled by the patient's care team.", 'eventGroups': [{'id': 'EG000', 'title': 'West Philadelphia Residents', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions\n\nTransportation: Eligible patients are contacted and offered free transportation to and from their upcoming appointment.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non West Philadelphia Residents', 'description': 'For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Scheduled Lung Cancer Screening Appointments Attended by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'West Philadelphia CSP Participants', 'description': 'West Philadelphia CSP Participants For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group opted into the CSP.'}, {'id': 'OG001', 'title': 'West Philadelphia Non CSP Participants', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group did not opt into the CSP.'}, {'id': 'OG002', 'title': 'Southwest Philadelphia Residents', 'description': 'For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The Primary Outcome measures the rate of appointment attendance across three groups: West Philadelphia CSP Participants (eligible West Philadelphia residents who opted into the CSP), West Philadelphia Non CSP Participants (eligible West Philadelphia residents who did not opt into the CSP), and Southwest Philadelphia Residents (patients who did not receive an option to participate in the CSP).', 'unitOfMeasure': '% of lcs appointment attendance', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of CSP Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'West Philadelphia Residents', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The Secondary outcome is a measurement of the percentage of eligible participants (West Philadelphia residents) who chose to opt into the CSP (as opposed to eligible participants who did not).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'West Philadelphia CSP Participants', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group opted into the CSP.'}, {'id': 'FG001', 'title': 'West Philadelphia Non CSP Participants', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group did not opt into the CSP.'}, {'id': 'FG002', 'title': 'Southwest Philadelphia Residents', 'description': 'For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'West Philadelphia CSP Participants', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group opted into the CSP.'}, {'id': 'BG001', 'title': 'West Philadelphia Non CSP Participants', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions. This group did not opt into the CSP.'}, {'id': 'BG002', 'title': 'Southwest Philadelphia Residents', 'description': 'For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18-89', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Scheduled Lung Cancer Screening', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-13', 'size': 829879, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-27T16:31', 'hasProtocol': True}, {'date': '2023-12-01', 'size': 395090, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-27T16:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2023-12-20', 'resultsFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-28', 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Scheduled Lung Cancer Screening Appointments Attended by Participants', 'timeFrame': '12 months', 'description': 'The Primary Outcome measures the rate of appointment attendance across three groups: West Philadelphia CSP Participants (eligible West Philadelphia residents who opted into the CSP), West Philadelphia Non CSP Participants (eligible West Philadelphia residents who did not opt into the CSP), and Southwest Philadelphia Residents (patients who did not receive an option to participate in the CSP).'}], 'secondaryOutcomes': [{'measure': 'Percentage of CSP Enrollment', 'timeFrame': '12 months', 'description': 'The Secondary outcome is a measurement of the percentage of eligible participants (West Philadelphia residents) who chose to opt into the CSP (as opposed to eligible participants who did not).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening adherence'], 'conditions': ['Lung Cancer', 'Behavior']}, 'descriptionModule': {'briefSummary': 'The research study aims to create a program for lung cancer screening attendance', 'detailedDescription': 'The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improving adherence to LCS follow-up guidelines in an urban environment. The project aims to collaborate with community partners to develop an infrastructure and iterative process to provide social support to community members that facilitates obtaining their follow-up LDCT for LCS. It utilizes novel population level data that includes geospatial analysis of neighborhood-level data of patients residing in Philadelphia who have received a LDCT for LCS. This allows for targeted community level interventions and the ability to evaluate impact on a population level.\n\nA Community Support Program Representative will reach out to eligible patients via telephone. The CSP Representative and Patient Navigator will communicate with consented patient directly, assist with travel and the appointment. The PN will log the date of the appointment, zip code of the patient and the adherence (or lack of) of the appointment completion. We will utilize Lyft transportation vouchers to provide rides to participants from their home location in West Philadelphia to and from the Penn Medicine downtown hospital locations on the day of their LDCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Upcoming or missed follow-up LDCT (low dose CT)\n* West Philadelphia resident\n* Between 18-89 years' old\n\nExclusion Criteria:\n\n* No upcoming LDCT\n* Lives outside West Philadelphia\n* Outside age range"}, 'identificationModule': {'nctId': 'NCT06207435', 'acronym': 'LCS', 'briefTitle': 'Community Support Program for Lung Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Community Support Program for Lung Cancer Screening', 'orgStudyIdInfo': {'id': 'UPCC 07523'}, 'secondaryIdInfos': [{'id': '852598', 'type': 'OTHER', 'domain': 'University of Pennsylvania IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'West Philadelphia Residents', 'description': 'For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions', 'interventionNames': ['Behavioral: Transportation']}, {'type': 'NO_INTERVENTION', 'label': 'Non West Philadelphia Residents', 'description': 'For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question.'}], 'interventions': [{'name': 'Transportation', 'type': 'BEHAVIORAL', 'description': 'Eligible patients are contacted and offered free transportation to and from their upcoming appointment.', 'armGroupLabels': ['West Philadelphia Residents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Farouk Dako, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}