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N/A N=1,422 Randomized Double-blind Screening

Digital Outreach Intervention for Lung Cancer Screening

Lung Cancer

Enrolled (actual)
1,422
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan — 164; 113 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
mPATH-Lung (Other); Lung health video (Other)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
164; 113
SECONDARY
LCS Screening Decision
SECONDARY
Proportion of Patients With LCS Clinic Visits Scheduled
SECONDARY
Proportion of Patients With LCS Clinic Visits Completed
SECONDARY
Proportion of Patients With LCS Scans Ordered
SECONDARY
LCS Clinic Referral Requested Through mPATH
SECONDARY
Lung Cancer Screening Test Results
SECONDARY
Number of LCS False Positives
SECONDARY
Invasive Procedures Following LCS Scan
SECONDARY
Proportion of Patients With Complications Following LCS
SECONDARY
Number of Diagnosed Lung Cancers
SECONDARY
How Diagnosed Lung Cancers Were Detected
SECONDARY
Stage of Lung Cancers Diagnosed
SECONDARY
Overscreening
SECONDARY
Reach of Digital Outreach Strategy
3267
SECONDARY
Completion of mPATH-Lung Program

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04083859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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