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

NCT ID: NCT07322367

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

27000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

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

Group Type EXPERIMENTAL

Portal Message with Reminder Text Messages

Intervention Type 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 B

Text message only with up to 3 reminder text messages.

Group Type EXPERIMENTAL

Text Message with Reminder Text Messages

Intervention Type 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 C

Portal message only with no reminder messages.

Group Type EXPERIMENTAL

Portal message only

Intervention Type OTHER

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

Usual Care Arm

Patients receive usual care.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Portal message only

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

Intervention Type OTHER

Usual Care

Standard of care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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:
Minimum Eligible Age

50 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brent Heideman, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordinator

Role: CONTACT

704-355-2000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator, MD

Role: primary

704-355-2000

Study Coordinator

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00139213

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Detection of Lung Cancer
NCT03181256 ACTIVE_NOT_RECRUITING
Lung Screening Study
NCT00006382 COMPLETED NA
Reminder Messages for Lung Cancer Screening
NCT05952778 ACTIVE_NOT_RECRUITING