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Completed

NCT Number: NCT04083859

Digital Outreach Intervention for Lung Cancer Screening

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina- Chapel Hill, Chapel Hill, North Carolina, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mPATH-Lung

Other

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

Other

Web-based video about guideline recommended exercise for lung health

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Lung Cancer Screening Test Results

    Time frame: 16 weeks

    The results of a completed lung cancer screening CT, reported using the Lung-RADS classification

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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.

  12. Stage of Lung Cancers Diagnosed

    Time frame: 16 months after randomization

    Stage of lung cancers diagnosed

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

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

Registry information

Official study title

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

Acronym: mPATH-Lung

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 10, 2019
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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