CClinicalTrials.gg
RecruitingNCT07322367Updated Mar 25, 2026

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

An interventional study of Portal Message with Reminder Text Messages and Text Message with Reminder Text Messages in Lung Cancer, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 50 Years to 77 Years. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
27,000
Allocation
Randomized
Ages
50 Years to 77 Years
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 27,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
27,000 participants (estimated)

Study arms

  • Experimental
    Arm A

    Patient portal message first followed by up to 3 reminder text messages.

    Other: Portal Message with Reminder Text Messages

  • Experimental
    Arm B

    Text message only with up to 3 reminder text messages.

    Other: Text Message with Reminder Text Messages

  • Experimental
    Arm C

    Portal message only with no reminder messages.

    Other: Portal message only

  • Active comparator
    Usual Care Arm

    Patients receive usual care.

    Other: Usual Care

Interventions

  • OtherPortal 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.

  • OtherText 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.

  • OtherPortal message only

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

  • OtherUsual Care

    Standard of care

06

What researchers measure

Primary outcomes

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

    Completion of the lung screening CT by participants.

    Time frame: 90 days

Secondary outcomes

  1. 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.

    Time frame: 90 days

  2. Number of Requests for Lung Screening

    Requests for lung screening within the mPATH-Lung program

    Time frame: 90 days

  3. Number of Orders for Lung Screening CT Scans

    Orders for lung screening CT scans for participants in study arms

    Time frame: Within 90 days of randomization

  4. Amount of Revenue Generated

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

    Time frame: 12 months following completion of screenings

  5. 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.

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Atrium Health Wake Forest Baptist
    Winston-Salem, North Carolina 27157, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07322367
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Mar 25, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Mar 25, 2026

Study contacts

Study Coordinator
Contact
Aliza.randazzo@advocatehealth.org
704-355-2000
Brent Heideman, Jr., MD
principal investigator · Wake Forest Baptist Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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