Mobile patient health technology to increase lung cancer screening in high‑risk adults

A Pragmatic Randomized-Controlled Learning Health System Trial

This project will test whether a mobile health tool combined with portal and text message outreach increases lung cancer screening among high‑risk adults eligible under current Medicare criteria.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 27000 (estimated)
• Ages: 50 Years to 77 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT07322367 on ClinicalTrials.gov

What this trial studies

This pragmatic, randomized controlled trial will embed an electronic outreach intervention (mPATH‑Lung) within an academic learning health system and randomize eligible patients to one of four outreach approaches: portal message only, portal message plus reminder texts, text message plus reminders, or usual care. The design intentionally enrolls fully powered cohorts of racial/ethnic minorities and rural residents to compare effectiveness across vulnerable subgroups. The primary outcome is uptake of lung cancer screening, with secondary aims to compare outreach strategies, estimate revenue from increased screening and downstream care, and evaluate potential over‑screening using HEDIS‑based exclusion criteria. The intervention is delivered via existing patient portal accounts or SMS and is restricted to patients established with the Wake Forest health network who have a North Carolina address.

Who should consider this trial

Good fit: Ideal participants are adults aged 50–77 with a ≥20 pack‑year smoking history who currently smoke or quit within the past 15 years, who are established with the Wake Forest primary care network, have a patient portal account or listed cellphone, and have a North Carolina address.

Not a fit: Patients who lack a portal account or cellphone number, are not established in the Wake Forest/Atrium Health network, live outside North Carolina, or require a non‑Spanish language interpreter are unlikely to benefit or cannot participate.

Why it matters

Potential benefit: If successful, the program could raise screening rates, help detect lung cancer earlier in high‑risk patients, and reduce disparities in screening access.

How similar studies have performed: Digital outreach and reminder messages have improved uptake for other cancer screening programs, but randomized evidence specifically testing portal/text interventions for lung cancer screening is limited, so this approach is partially supported but still relatively novel.

Eligibility criteria

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.

Where this trial is running

Winston-Salem, North Carolina

• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Brent Heideman, Jr., MD — Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Study Coordinator

Conditions Lung Cancer