Digital Outreach Intervention for Lung Cancer Screening
NCT ID: NCT04083859
Last Updated: 2025-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26998 participants
INTERVENTIONAL
2022-01-01
2024-09-30
Brief Summary
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This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.
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Detailed Description
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Secondary Objectives:
* 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.
* Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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mPATH-Lung
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.
mPATH-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.
Usual care (CONTROL)
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.
Lung health video
Web-based video about guideline recommended exercise for lung health
Interventions
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mPATH-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.
Lung health video
Web-based video about guideline recommended exercise for lung health
Eligibility Criteria
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Inclusion Criteria
* Age 50 - 77 years
* Smoked at least 20 pack years
* Current smoker or quit smoking within the past 15 years
* Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
* Have a patient portal account or cellphone number listed in the electronic health record
Exclusion Criteria
* Those for whom lung cancer screening would be inappropriate:
* Prior history of lung cancer
* Chest CT within the last 12 months
* Those with medical conditions predicting shorter life expectancy
* Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)
50 Years
77 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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David P Miller, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00060382
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00060382
Identifier Type: -
Identifier Source: org_study_id
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