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NCT Number: NCT07322367

A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients

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.

Recruiting

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Key information

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Brent Heideman, Jr., MD

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

Study Coordinator, MD

CONTACT

[email protected]

704-355-2000

About this study

Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.

Secondary Objectives

  • Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups.
  • Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care.
  • Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Eligible patients will:

  • 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 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).
  • Have a patient portal account or cellphone number listed in the electronic health record
  • Have a North Carolina address listed in the electronic health record

Exclusion criteria

The following patients will be excluded:

  • 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)
  • Those for whom lung cancer screening would be or may be inappropriate:

electronic 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.

Treatment and study plan

Portal Message with Reminder Text Messages

Other

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.

If 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.

Text Message with Reminder Text Messages

Other

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.

If 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.

Portal message only

Other

Participant will only receive portal message with no reminder text messages.

Usual Care

Other

Standard of care

Primary outcomes

  1. Number of Participants to Complete Lung Screening CT - Primary Effectiveness

    Time frame: 90 days

    Completion of the lung screening CT by participants.

Secondary outcomes

  1. Number of Participants with Eligibility for Lung Screening

    Time frame: 90 days

    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.

  2. Number of Requests for Lung Screening

    Time frame: 90 days

    Requests for lung screening within the mPATH-Lung program

  3. Number of Orders for Lung Screening CT Scans

    Time frame: Within 90 days of randomization

    Orders for lung screening CT scans for participants in study arms

  4. Amount of Revenue Generated

    Time frame: 12 months following completion of screenings

    Revenue (costs) generated from lung cancer screening and follow-up care.

  5. Number of Participants that Represent Over-screening

    Time frame: 90 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

704-355-2000

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pragmatic Randomized-Controlled Learning Health System Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Mar 25, 2026

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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