Digital Outreach Intervention for Lung Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill. Secondary Objectives: Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients. Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings

Official Title
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A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: mPATH-Lung
* Other: Lung health video


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mPATH-Lung<br>Participants randomized to the mPATH arm will complete a self-survey and a brief video decision aid, and then invites them to estimate their personal risks and benefits of screening by completing 8 survey items needed to calculate their predicted risk of developing lung cancer based on the validated Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Model 2012. | Other: mPATH-Lung<br>* 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.<br>|
| Placebo Comparator: Usual care (CONTROL)<br>Participants randomized to the control arm will see an animated video about exercise for lung health based on recommendations from the European Lung Foundation. 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<br>* Web-based video about guideline recommended exercise for lung health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic health record-verified completion of a lung cancer screening CT scan | Completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review | Within 16 weeks of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCS Screening decision | Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only | Up to 16 weeks after day of enrollment | 
| Proportion of patients with LCS clinic visits scheduled | The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed | 16 weeks | 
| Proportion of patients with LCS clinic visits completed | The proportion of patients in each arm who have completed a LCS clinic visit | 16 weeks | 
| Proportion of patients with LCS scans ordered | The proportion of patients in each arm for whom a LCS scan was ordered | 16 weeks | 
| LCS clinic referral requested through mPATH | The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment. | 16 weeks | 
| Lung cancer screening test results | The results of a completed lung cancer screening CT, reported using the Lung-RADS classification | 16 weeks | 
| Number of LCS false positives | A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan. | 1 year | 
| Invasive procedures following LCS scan | The proportion of patients in each arm who undergo an invasive procedure following a LCS scan | 1 year | 
| Proportion of patients with complications following LCS | The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan | 1 year | 
| Number of diagnosed lung cancers | Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization | 16 months after randomization | 
| How diagnosed lung cancers were detected | Proportion of patients who had lung cancers detected related to screening or incidentally. | 16 months after randomization | 
| Stage of lung cancers diagnosed | Stage of lung cancers diagnosed | 16 months after randomization | 
| Overscreening | The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review. | 1 year | 
| Reach of digital outreach strategy | The proportion of patients sent a digital invitation who complete the eligibility questions on the study website. | 16 weeks | 
| Completion of mPATH-Lung program | The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass screening, Early detection of cancer, Digital health interventions, Decision making, computer assisted