Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT04083859
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2019-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Digital Outreach Intervention for Lung Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmiller@wakehealth.edu', 'phone': '336-713-5218', 'title': 'Dr. David P. Miller, Jr', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'No adverse event details were collected for participants in the "Primary Care Providers" arm.', 'eventGroups': [{'id': 'EG000', 'title': 'mPATH-Lung', 'description': 'Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.\n\nmPATH-Lung: A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.', 'otherNumAtRisk': 669, 'deathsNumAtRisk': 669, 'otherNumAffected': 0, 'seriousNumAtRisk': 669, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care (CONTROL)', 'description': 'Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.\n\nLung health video: Web-based video about guideline recommended exercise for lung health', 'otherNumAtRisk': 664, 'deathsNumAtRisk': 664, 'otherNumAffected': 0, 'seriousNumAtRisk': 664, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mPATH-Lung', 'description': 'Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.\n\nmPATH-Lung: A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.'}, {'id': 'OG001', 'title': 'Usual Care (CONTROL)', 'description': 'Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.\n\nLung health video: Web-based video about guideline recommended exercise for lung health'}], 'classes': [{'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 16 weeks of enrollment', 'description': 'Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This population includes all participants who used the mPATH program to the point of randomization.'}, {'type': 'SECONDARY', 'title': 'LCS Screening Decision', 'timeFrame': 'Up to 16 weeks after day of enrollment', 'description': 'Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With LCS Clinic Visits Scheduled', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With LCS Clinic Visits Completed', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm who have completed a LCS clinic visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With LCS Scans Ordered', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm for whom a LCS scan was ordered', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'LCS Clinic Referral Requested Through mPATH', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Screening Test Results', 'timeFrame': '16 weeks', 'description': 'The results of a completed lung cancer screening CT, reported using the Lung-RADS classification', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of LCS False Positives', 'timeFrame': '1 year', 'description': 'A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Invasive Procedures Following LCS Scan', 'timeFrame': '1 year', 'description': 'The proportion of patients in each arm who undergo an invasive procedure following a LCS scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Complications Following LCS', 'timeFrame': '1 year', 'description': 'The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Diagnosed Lung Cancers', 'timeFrame': '16 months after randomization', 'description': 'Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'How Diagnosed Lung Cancers Were Detected', 'timeFrame': '16 months after randomization', 'description': 'Proportion of patients who had lung cancers detected related to screening or incidentally.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Stage of Lung Cancers Diagnosed', 'timeFrame': '16 months after randomization', 'description': 'Stage of lung cancers diagnosed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Overscreening', 'timeFrame': '1 year', 'description': 'The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Reach of Digital Outreach Strategy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26909', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Invited to Use mPATH', 'description': 'All individuals who were sent an invitation to use the mPATH program.'}], 'classes': [{'categories': [{'measurements': [{'value': '3267', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who were sent an invitation to use the mPATH program.'}, {'type': 'SECONDARY', 'title': 'Completion of mPATH-Lung Program', 'timeFrame': '16 weeks', 'description': 'The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'mPATH-Lung', 'description': 'Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.\n\nmPATH-Lung: A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.'}, {'id': 'FG001', 'title': 'Usual Care (CONTROL)', 'description': 'Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.\n\nLung health video: Web-based video about guideline recommended exercise for lung health'}, {'id': 'FG002', 'title': 'Primary Care Providers', 'description': 'Primary care providers who completed a survey about their experiences.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '669'}, {'groupId': 'FG001', 'numSubjects': '664'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '669'}, {'groupId': 'FG001', 'numSubjects': '664'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants are considered enrolled in this study when they are randomly selected by the study team to receive an invitation to use mPATH. Of the 26,909 people who were sent invitation messages, 3,267 visited the mPATH program and completed eligibility questions, and 1,333 were confirmed eligible for LCS and subsequently randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'BG000'}, {'value': '664', 'groupId': 'BG001'}, {'value': '1333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'mPATH-Lung', 'description': 'Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.\n\nmPATH-Lung: A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.'}, {'id': 'BG001', 'title': 'Usual Care (CONTROL)', 'description': 'Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.\n\nLung health video: Web-based video about guideline recommended exercise for lung health'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '483', 'groupId': 'BG001'}, {'value': '941', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '425', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '664', 'groupId': 'BG000'}, {'value': '651', 'groupId': 'BG001'}, {'value': '1315', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '533', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who were determined to be eligible for LCS based on their responses to initial questions in the mPATH program were randomized into either the intervention or enhanced usual care arm. No baseline characteristics were collected for participants in the "Primary Care Providers" arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-17', 'size': 628390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-17T11:38', 'hasProtocol': True}, {'date': '2023-11-28', 'size': 136226, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-28T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26998}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2019-08-30', 'resultsFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2019-09-06', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-14', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan', 'timeFrame': 'Within 16 weeks of enrollment', 'description': 'Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review'}], 'secondaryOutcomes': [{'measure': 'LCS Screening Decision', 'timeFrame': 'Up to 16 weeks after day of enrollment', 'description': 'Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only'}, {'measure': 'Proportion of Patients With LCS Clinic Visits Scheduled', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed'}, {'measure': 'Proportion of Patients With LCS Clinic Visits Completed', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm who have completed a LCS clinic visit'}, {'measure': 'Proportion of Patients With LCS Scans Ordered', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in each arm for whom a LCS scan was ordered'}, {'measure': 'LCS Clinic Referral Requested Through mPATH', 'timeFrame': '16 weeks', 'description': 'The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.'}, {'measure': 'Lung Cancer Screening Test Results', 'timeFrame': '16 weeks', 'description': 'The results of a completed lung cancer screening CT, reported using the Lung-RADS classification'}, {'measure': 'Number of LCS False Positives', 'timeFrame': '1 year', 'description': 'A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.'}, {'measure': 'Invasive Procedures Following LCS Scan', 'timeFrame': '1 year', 'description': 'The proportion of patients in each arm who undergo an invasive procedure following a LCS scan'}, {'measure': 'Proportion of Patients With Complications Following LCS', 'timeFrame': '1 year', 'description': 'The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan'}, {'measure': 'Number of Diagnosed Lung Cancers', 'timeFrame': '16 months after randomization', 'description': 'Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization'}, {'measure': 'How Diagnosed Lung Cancers Were Detected', 'timeFrame': '16 months after randomization', 'description': 'Proportion of patients who had lung cancers detected related to screening or incidentally.'}, {'measure': 'Stage of Lung Cancers Diagnosed', 'timeFrame': '16 months after randomization', 'description': 'Stage of lung cancers diagnosed'}, {'measure': 'Overscreening', 'timeFrame': '1 year', 'description': 'The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.'}, {'measure': 'Reach of Digital Outreach Strategy', 'timeFrame': '16 weeks', 'description': 'The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.'}, {'measure': 'Completion of mPATH-Lung Program', 'timeFrame': '16 weeks', 'description': 'The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mass screening', 'Early detection of cancer', 'Digital health interventions', 'Decision making, computer assisted'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33532112', 'type': 'BACKGROUND', 'citation': "Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available."}, {'pmid': '21714641', 'type': 'BACKGROUND', 'citation': 'National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.'}, {'pmid': '24037918', 'type': 'BACKGROUND', 'citation': 'Pinsky PF, Church TR, Izmirlian G, Kramer BS. The National Lung Screening Trial: results stratified by demographics, smoking history, and lung cancer histology. Cancer. 2013 Nov 15;119(22):3976-83. doi: 10.1002/cncr.28326. Epub 2013 Aug 26.'}, {'pmid': '24378917', 'type': 'BACKGROUND', 'citation': 'Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.'}, {'pmid': '23315954', 'type': 'BACKGROUND', 'citation': 'Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.'}, {'pmid': '22710039', 'type': 'BACKGROUND', 'citation': 'Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Medicare & Medicaid Services. Final National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).; 2015. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed November 10, 2015.'}, {'pmid': '28152136', 'type': 'BACKGROUND', 'citation': 'Jemal A, Fedewa SA. Lung Cancer Screening With Low-Dose Computed Tomography in the United States-2010 to 2015. JAMA Oncol. 2017 Sep 1;3(9):1278-1281. doi: 10.1001/jamaoncol.2016.6416.'}, {'pmid': '22610500', 'type': 'BACKGROUND', 'citation': 'Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.'}, {'pmid': '24322781', 'type': 'BACKGROUND', 'citation': 'Harris RP, Sheridan SL, Lewis CL, Barclay C, Vu MB, Kistler CE, Golin CE, DeFrank JT, Brewer NT. The harms of screening: a proposed taxonomy and application to lung cancer screening. JAMA Intern Med. 2014 Feb 1;174(2):281-5. doi: 10.1001/jamainternmed.2013.12745.'}, {'pmid': '23208167', 'type': 'BACKGROUND', 'citation': 'Veronesi G, Maisonneuve P, Bellomi M, Rampinelli C, Durli I, Bertolotti R, Spaggiari L. Estimating overdiagnosis in low-dose computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2012 Dec 4;157(11):776-84. doi: 10.7326/0003-4819-157-11-201212040-00005.'}, {'pmid': '16757691', 'type': 'BACKGROUND', 'citation': 'Patz EF Jr. Lung cancer screening, overdiagnosis bias, and reevaluation of the Mayo Lung Project. J Natl Cancer Inst. 2006 Jun 7;98(11):724-5. doi: 10.1093/jnci/djj226. 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BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1.'}, {'pmid': '24625261', 'type': 'BACKGROUND', 'citation': 'Fagerlin A, Pignone M, Abhyankar P, Col N, Feldman-Stewart D, Gavaruzzi T, Kryworuchko J, Levin CA, Pieterse AH, Reyna V, Stiggelbout A, Scherer LD, Wills C, Witteman HO. Clarifying values: an updated review. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S8. doi: 10.1186/1472-6947-13-S2-S8. Epub 2013 Nov 29.'}, {'pmid': '16908462', 'type': 'BACKGROUND', 'citation': "Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. 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Epub 2016 Jun 23.'}, {'pmid': '27241830', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Tan AS, Salloum RG, Young-Wolff KC. Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS). Patient Educ Couns. 2016 Nov;99(11):1772-1777. doi: 10.1016/j.pec.2016.05.014. Epub 2016 May 17.'}, {'pmid': '30105393', 'type': 'BACKGROUND', 'citation': 'Brenner AT, Malo TL, Margolis M, Elston Lafata J, James S, Vu MB, Reuland DS. Evaluating Shared Decision Making for Lung Cancer Screening. JAMA Intern Med. 2018 Oct 1;178(10):1311-1316. doi: 10.1001/jamainternmed.2018.3054.'}, {'pmid': '24518006', 'type': 'BACKGROUND', 'citation': 'Volk RJ, Linder SK, Leal VB, Rabius V, Cinciripini PM, Kamath GR, Munden RF, Bevers TB. Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography. Prev Med. 2014 May;62:60-3. doi: 10.1016/j.ypmed.2014.02.006. Epub 2014 Feb 8.'}, {'pmid': '27966194', 'type': 'BACKGROUND', 'citation': 'Housten AJ, Lowenstein LM, Leal VB, Volk RJ. Responsiveness of a Brief Measure of Lung Cancer Screening Knowledge. J Cancer Educ. 2018 Aug;33(4):842-846. doi: 10.1007/s13187-016-1153-8.'}, {'pmid': '30620619', 'type': 'BACKGROUND', 'citation': 'Bellinger C, Pinsky P, Foley K, Case D, Dharod A, Miller D. Lung Cancer Screening Benefits and Harms Stratified by Patient Risk: Information to Improve Patient Decision Aids. Ann Am Thorac Soc. 2019 Apr;16(4):512-514. doi: 10.1513/AnnalsATS.201810-690RL. No abstract available.'}, {'pmid': '30625501', 'type': 'BACKGROUND', 'citation': 'Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.'}, {'pmid': '28400354', 'type': 'BACKGROUND', 'citation': 'Miller DP Jr, Weaver KE, Case LD, Babcock D, Lawler D, Denizard-Thompson N, Pignone MP, Spangler JG. Usability of a Novel Mobile Health iPad App by Vulnerable Populations. JMIR Mhealth Uhealth. 2017 Apr 11;5(4):e43. doi: 10.2196/mhealth.7268.'}, {'pmid': '29800127', 'type': 'BACKGROUND', 'citation': 'Katki HA, Kovalchik SA, Petito LC, Cheung LC, Jacobs E, Jemal A, Berg CD, Chaturvedi AK. Implications of Nine Risk Prediction Models for Selecting Ever-Smokers for Computed Tomography Lung Cancer Screening. Ann Intern Med. 2018 Jul 3;169(1):10-19. doi: 10.7326/M17-2701. Epub 2018 May 15.'}, {'pmid': '28929865', 'type': 'BACKGROUND', 'citation': 'Pinsky PF, Bellinger CR, Miller DP Jr. False-positive screens and lung cancer risk in the National Lung Screening Trial: Implications for shared decision-making. J Med Screen. 2018 Jun;25(2):110-112. doi: 10.1177/0969141317727771. Epub 2017 Sep 20.'}, {'pmid': '21931068', 'type': 'BACKGROUND', 'citation': 'Fagerlin A, Zikmund-Fisher BJ, Ubel PA. Helping patients decide: ten steps to better risk communication. J Natl Cancer Inst. 2011 Oct 5;103(19):1436-43. doi: 10.1093/jnci/djr318. Epub 2011 Sep 19.'}, {'pmid': '18755566', 'type': 'BACKGROUND', 'citation': 'Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008 Dec;73(3):448-55. doi: 10.1016/j.pec.2008.07.023. Epub 2008 Aug 27.'}, {'pmid': '30288444', 'type': 'BACKGROUND', 'citation': "Hoffman AS, Hempstead AP, Housten AJ, Richards VF, Lowenstein LM, Leal VB, Volk RJ. Using a Patient Decision Aid Video to Assess Current and Former Smokers' Values About the Harms and Benefits of Lung Cancer Screening With Low-Dose Computed Tomography. MDM Policy Pract. 2018 Apr 19;3(1):2381468318769886. doi: 10.1177/2381468318769886. eCollection 2018 Jan-Jun."}, {'pmid': '23400279', 'type': 'BACKGROUND', 'citation': 'Pignone MP, Howard K, Brenner AT, Crutchfield TM, Hawley ST, Lewis CL, Sheridan SL. Comparing 3 techniques for eliciting patient values for decision making about prostate-specific antigen screening: a randomized controlled trial. JAMA Intern Med. 2013 Mar 11;173(5):362-8. doi: 10.1001/jamainternmed.2013.2651.'}, {'pmid': '28851459', 'type': 'BACKGROUND', 'citation': 'Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.'}, {'pmid': '27512650', 'type': 'BACKGROUND', 'citation': "Lowenstein LM, Richards VF, Leal VB, Housten AJ, Bevers TB, Cantor SB, Cinciripini PM, Cofta-Woerpel LM, Escoto KH, Godoy MC, Linder SK, Munden RF, Volk RJ. A brief measure of Smokers' knowledge of lung cancer screening with low-dose computed tomography. Prev Med Rep. 2016 Jul 26;4:351-6. doi: 10.1016/j.pmedr.2016.07.008. eCollection 2016 Dec."}, {'type': 'BACKGROUND', 'citation': 'Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability Scale. Int J Human-Computer Interact. 2008;24(6):574-594. doi:10.1080/10447310802205776'}, {'pmid': '30622199', 'type': 'BACKGROUND', 'citation': 'Henderson LM, Marsh MW, Benefield TS, Jones LM, Reuland DS, Brenner AT, Goldstein AO, Molina PL, Maygarden SJ, Rivera MP. Opinions and Practices of Lung Cancer Screening by Physician Specialty. N C Med J. 2019 Jan-Feb;80(1):19-26. doi: 10.18043/ncm.80.1.19.'}, {'pmid': '41114973', 'type': 'DERIVED', 'citation': 'Miller DP, Snavely AC, Dharod A, Brenner AT, Wright E, Stradtman L, Bellinger CR, Bundy R, Volk RJ, Hamburger E, Ferrari RM, Randazzo A, Reuland DS. A Direct-to-Patient Digital Health Program for Lung Cancer Screening: A Randomized Clinical Trial. JAMA. 2025 Nov 25;334(20):1807-1815. doi: 10.1001/jama.2025.17281.'}]}, 'descriptionModule': {'briefSummary': "mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.\n\nThis project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.", 'detailedDescription': "Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.\n\nSecondary Objectives:\n\n* Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.\n* Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the Medicare criteria for lung cancer screening, as updated in February 2022:\n\n * Age 50 - 77 years\n * Smoked at least 20 pack years\n * Current smoker or quit smoking within the past 15 years\n* Be scheduled to see a primary care provider within the health network in the next 3-4 weeks\n* Have a patient portal account or cellphone number listed in the electronic health record\n\nExclusion Criteria:\n\n* Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).\n* Those for whom lung cancer screening would be inappropriate:\n\n * Prior history of lung cancer\n * Chest CT within the last 12 months\n * Those with medical conditions predicting shorter life expectancy\n * Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)'}, 'identificationModule': {'nctId': 'NCT04083859', 'acronym': 'mPATH-Lung', 'briefTitle': 'Digital Outreach Intervention for Lung Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)', 'orgStudyIdInfo': {'id': 'IRB00060382'}, 'secondaryIdInfos': [{'id': 'IRB00060382', 'type': 'OTHER', 'domain': 'Institutional Review Board - Wake Forest University Health Science'}, {'id': '1R01CA237240', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA237240', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mPATH-Lung', 'description': 'Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.', 'interventionNames': ['Other: mPATH-Lung']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual care (CONTROL)', 'description': 'Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.', 'interventionNames': ['Other: Lung health video']}], 'interventions': [{'name': 'mPATH-Lung', 'type': 'OTHER', 'description': 'A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.', 'armGroupLabels': ['mPATH-Lung']}, {'name': 'Lung health video', 'type': 'OTHER', 'description': 'Web-based video about guideline recommended exercise for lung health', 'armGroupLabels': ['Usual care (CONTROL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina- Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David P Miller, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'We will make the de-identified data available within one year of the publication of the relevant results. Data will remain available for at least 5 years from the last publication of results.', 'ipdSharing': 'YES', 'description': 'We will share de-identified individual participant data that underlie our published or presented results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.', 'accessCriteria': 'Researchers desiring data access must provide a methodologically sound proposal to the study principal investigator. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}