Recruiting

Implementation Strategies

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07322367

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Portal Message with Reminder Text Messages

Text Message with Reminder Text Messages

Portal message only

Usual Care

Study Details

Brief 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.

Conditions

Lung Cancer

Study ID

NCT07322367

Start date

Mar 25, 2026

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

27000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Arm A

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

experimental: Arm B

Text message only with up to 3 reminder text messages.

experimental: Arm C

Portal message only with no reminder messages.

active comparator: Usual Care Arm

Patients receive usual care.

Interventions

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.

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.

Portal message only

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

Usual Care

Standard of care

Primary outcome measure

  • Number of Participants to Complete Lung Screening CT - Primary Effectiveness [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Study Coordinator

704-355-2000Aliza.randazzo@advocatehealth.org

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Study Coordinator, MD

704-355-2000Aliza.randazzo@advocatehealth.org

Principal Investigator:

Brent Heideman, Jr., MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-25.