Digital Outreach Intervention for Lung Cancer Screening

NCT04083859 | Completed Results

• 2 other identifiers: IRB000603821R01CA237240
• Study Type: interventional
• Target: 26,998
• Locations: 1 country
• Sites: 2

Brief Summary

mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews. This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.

Conditions

Lung Cancer

Keywords

Mass screening; Early detection of cancer; Digital health interventions; Decision making, computer assisted

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan

  Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review

  Within 16 weeks of enrollment

Secondary Outcomes (15)

• LCS Screening Decision

  Up to 16 weeks after day of enrollment

• Proportion of Patients With LCS Clinic Visits Scheduled

  16 weeks

• Proportion of Patients With LCS Clinic Visits Completed

  16 weeks

• Proportion of Patients With LCS Scans Ordered

  16 weeks

• LCS Clinic Referral Requested Through mPATH

  16 weeks

Study Arms (2)

mPATH-Lung

EXPERIMENTAL

Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.

Other: mPATH-Lung

Usual care (CONTROL)

PLACEBO COMPARATOR

Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.

Other: Lung health video

Interventions

mPATH-Lung OTHER

A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.

mPATH-Lung

Lung health video OTHER

Web-based video about guideline recommended exercise for lung health

Usual care (CONTROL)

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 scheduled to see a primary care provider within the health network in the next 3-4 weeks
• Have a patient portal account or cellphone number listed in the electronic health record

You may not qualify if:

• Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
• Those for whom lung cancer screening would be inappropriate:
• Prior history of lung cancer
• Chest CT within the last 12 months
• Those with medical conditions predicting shorter life expectancy
• Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of North Carolina, Chapel Hill: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27101, United States

Location

Related Publications (52)

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  PMID: 41114973 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. David P. Miller, Jr
• Organization: Wake Forest University School of Medicine

dmiller@wakehealth.edu

336-713-5218

Study Officials

• David P Miller, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 10, 2019
• Study Start: January 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: June 25, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We will make the de-identified data available within one year of the publication of the relevant results. Data will remain available for at least 5 years from the last publication of results.
• Access Criteria: Researchers desiring data access must provide a methodologically sound proposal to the study principal investigator. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)