Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:26 AM
Study NCT ID:
NCT07322367
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-24', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants to Complete Lung Screening CT - Primary Effectiveness', 'timeFrame': '90 days', 'description': 'Completion of the lung screening CT by participants.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Eligibility for Lung Screening', 'timeFrame': '90 days', 'description': 'Reach of the mPATH-Lung platform, defined as the participants who determine their eligibility for lung screening within the mPATH-Lung program within 90 days of the first invitation. Investigators will determine reach overall, within subgroups, and within study arms.'}, {'measure': 'Number of Requests for Lung Screening', 'timeFrame': '90 days', 'description': 'Requests for lung screening within the mPATH-Lung program'}, {'measure': 'Number of Orders for Lung Screening CT Scans', 'timeFrame': 'Within 90 days of randomization', 'description': 'Orders for lung screening CT scans for participants in study arms'}, {'measure': 'Amount of Revenue Generated', 'timeFrame': '12 months following completion of screenings', 'description': 'Revenue (costs) generated from lung cancer screening and follow-up care.'}, {'measure': 'Number of Participants that Represent Over-screening', 'timeFrame': '90 days', 'description': 'Among patients with newly diagnosed lung cancer by lung screening, the participants that represent over-screening, defined as a patient being deemed too ill for potentially curative surgery on blinded chart review.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.', 'detailedDescription': 'Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.\n\nSecondary Objectives\n\n* Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups.\n* Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care.\n* Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible patients will:\n\n* Meet the Medicare criteria for lung cancer screening, as updated in February 2022:\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 established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days).\n* Have a patient portal account or cellphone number listed in the electronic health record\n* Have a North Carolina address listed in the electronic health record\n\nExclusion Criteria:\n\nThe following patients will be excluded:\n\n* Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)\n* Those for whom lung cancer screening would be or may be inappropriate:\n\nelectronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure exclusion criteria based on significant comorbidities and/or frailty.'}, 'identificationModule': {'nctId': 'NCT07322367', 'briefTitle': 'A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pragmatic Randomized-Controlled Learning Health System Trial', 'orgStudyIdInfo': {'id': 'IRB00139213'}, 'secondaryIdInfos': [{'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Patient portal message first followed by up to 3 reminder text messages.', 'interventionNames': ['Other: Portal Message with Reminder Text Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Text message only with up to 3 reminder text messages.', 'interventionNames': ['Other: Text Message with Reminder Text Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Portal message only with no reminder messages.', 'interventionNames': ['Other: Portal message only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Arm', 'description': 'Patients receive usual care.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Portal Message with Reminder Text Messages', 'type': 'OTHER', 'description': "If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder if they start the mPATH-Lung program but do not complete it.\n\nIf the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.", 'armGroupLabels': ['Arm A']}, {'name': 'Text Message with Reminder Text Messages', 'type': 'OTHER', 'description': "If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder.\n\nIf the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.", 'armGroupLabels': ['Arm B']}, {'name': 'Portal message only', 'type': 'OTHER', 'description': 'Participant will only receive portal message with no reminder text messages.', 'armGroupLabels': ['Arm C']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Usual Care Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator, MD', 'role': 'CONTACT', 'email': 'Aliza.randazzo@advocatehealth.org', 'phone': '704-355-2000'}, {'name': 'Study Coordinator', 'role': 'CONTACT'}, {'name': 'Brent Heideman, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health Wake Forest Baptist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'Aliza.randazzo@advocatehealth.org', 'phone': '704-355-2000'}], 'overallOfficials': [{'name': 'Brent Heideman, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Baptist Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}