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

NCT07322367 | Recruiting

• 2 other identifiers: IRB00139213P30CA012197
• Study Type: interventional
• Target: 27,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants to Complete Lung Screening CT - Primary Effectiveness

  Completion of the lung screening CT by participants.

  90 days

Secondary Outcomes (5)

• Number of Participants with Eligibility for Lung Screening

  90 days

• Number of Requests for Lung Screening

  90 days

• Number of Orders for Lung Screening CT Scans

  Within 90 days of randomization

• Amount of Revenue Generated

  12 months following completion of screenings

• Number of Participants that Represent Over-screening

  90 days

Study Arms (4)

Arm A

EXPERIMENTAL

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

Other: Portal Message with Reminder Text Messages

Arm B

EXPERIMENTAL

Text message only with up to 3 reminder text messages.

Other: Text Message with Reminder Text Messages

Arm C

EXPERIMENTAL

Portal message only with no reminder messages.

Other: Portal message only

Usual Care Arm

ACTIVE COMPARATOR

Patients receive usual care.

Other: Usual Care

Interventions

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.

Arm A

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.

Arm B

Portal message only OTHER

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

Arm C

Usual Care OTHER

Standard of care

Usual Care Arm

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Brent Heideman, Jr., MD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)