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

A Pragmatic Randomized-Controlled Learning Health System Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Portal Message with Reminder Text Messages; Other: Text Message with Reminder Text Messages; Other: Portal message only; Other: Usual Care

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 27000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 704-355-2000; Email: Aliza.randazzo@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
      • Contact: Study Coordinator
      • Contact: Study Coordinator, MD; Phone Number: 704-355-2000; Email: Aliza.randazzo@advocatehealth.org
      • Principal Investigator: Brent Heideman, Jr., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Patient portal message first followed by up to 3 reminder text messages.	Other: Portal Message with Reminder Text Messages; 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.
Experimental: Arm B; Text message only with up to 3 reminder text messages.	Other: Text Message with Reminder Text Messages; 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.
Experimental: Arm C; Portal message only with no reminder messages.	Other: Portal message only; Participant will only receive portal message with no reminder text messages.
Active Comparator: Usual Care Arm; Patients receive usual care.	Other: Usual Care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants to Complete Lung Screening CT - Primary Effectiveness	Completion of the lung screening CT by participants.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Eligibility for Lung Screening	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.	90 days
Number of Requests for Lung Screening	Requests for lung screening within the mPATH-Lung program	90 days
Number of Orders for Lung Screening CT Scans	Orders for lung screening CT scans for participants in study arms	Within 90 days of randomization
Amount of Revenue Generated	Revenue (costs) generated from lung cancer screening and follow-up care.	12 months following completion of screenings
Number of Participants that Represent Over-screening	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.	90 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Brent Heideman, Jr., MD, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IRB00139213; P30CA012197 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No