Digital Outreach Intervention for Lung Cancer Screening

Lung Cancer Clinical Trial

— mPATH-Lung  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04083859
• Other study ID #: IRB00060382
• Secondary ID: IRB000603821R01C
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28410
• Est. completion date: September 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 77 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• mPATH-Lung
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.
• Lung health video
Web-based video about guideline recommended exercise for lung health

Locations

Country	Name	City	State
United States	University of North Carolina- Chapel Hill	Chapel Hill	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of patients with LCS clinic visits completed	The proportion of patients in each arm who have completed a LCS clinic visit	16 weeks
Secondary	Proportion of patients with LCS scans ordered	The proportion of patients in each arm for whom a LCS scan was ordered	16 weeks
Secondary	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
Secondary	Lung cancer screening test results	The results of a completed lung cancer screening CT, reported using the Lung-RADS classification	16 weeks
Secondary	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
Secondary	Invasive procedures following LCS scan	The proportion of patients in each arm who undergo an invasive procedure following a LCS scan	1 year
Secondary	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
Secondary	Number of diagnosed lung cancers	Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization	16 months after randomization
Secondary	How diagnosed lung cancers were detected	Proportion of patients who had lung cancers detected related to screening or incidentally.	16 months after randomization
Secondary	Stage of lung cancers diagnosed	Stage of lung cancers diagnosed	16 months after randomization
Secondary	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
Secondary	Reach of digital outreach strategy	The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.	16 weeks
Secondary	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