Digital Outreach Intervention for Lung Cancer Screening (mPATH-Lung)

June 17, 2025 updated by: Wake Forest University Health Sciences

A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)

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.

This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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

Study Type

Interventional

Enrollment (Actual)

26998

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina- Chapel Hill
      • Winston-Salem, North Carolina, United States, 27101
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Meet the Medicare criteria for lung cancer screening, as updated in February 2022:

    • 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:

  • Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Placebo Comparator: 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.
Other: Lung health video
Web-based video about guideline recommended exercise for lung health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
Time Frame: Within 16 weeks of enrollment
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
Within 16 weeks of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overscreening
Time Frame: 1 year
The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.
1 year
LCS Screening Decision
Time Frame: Up to 16 weeks after day of enrollment
Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only
Up to 16 weeks after day of enrollment
Proportion of Patients With LCS Clinic Visits Scheduled
Time Frame: 16 weeks
The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed
16 weeks
Proportion of Patients With LCS Clinic Visits Completed
Time Frame: 16 weeks
The proportion of patients in each arm who have completed a LCS clinic visit
16 weeks
Proportion of Patients With LCS Scans Ordered
Time Frame: 16 weeks
The proportion of patients in each arm for whom a LCS scan was ordered
16 weeks
LCS Clinic Referral Requested Through mPATH
Time Frame: 16 weeks
The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.
16 weeks
Lung Cancer Screening Test Results
Time Frame: 16 weeks
The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
16 weeks
Number of LCS False Positives
Time Frame: 1 year
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.
1 year
Invasive Procedures Following LCS Scan
Time Frame: 1 year
The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
1 year
Proportion of Patients With Complications Following LCS
Time Frame: 1 year
The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan
1 year
Number of Diagnosed Lung Cancers
Time Frame: 16 months after randomization
Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization
16 months after randomization
How Diagnosed Lung Cancers Were Detected
Time Frame: 16 months after randomization
Proportion of patients who had lung cancers detected related to screening or incidentally.
16 months after randomization
Stage of Lung Cancers Diagnosed
Time Frame: 16 months after randomization
Stage of lung cancers diagnosed
16 months after randomization
Reach of Digital Outreach Strategy
Time Frame: 16 weeks
The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
16 weeks
Completion of mPATH-Lung Program
Time Frame: 16 weeks
The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: David P Miller, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00060382 (Other Identifier: Institutional Review Board - Wake Forest University Health Science)
  • 1R01CA237240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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