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mPATH-Lung: Digital Outreach Intervention for Lung Cancer Screening

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04083859
Collaborator
University of North Carolina, Chapel Hill (Other), National Cancer Institute (NCI) (NIH)
1,320
Enrollment
2
Locations
2
Arms
33
Anticipated Duration (Months)
660
Patients Per Site
20
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mPATH-Lung
  • Other: Lung health video
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: mPATH-Lung

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
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.
Placebo Comparator: Usual care (CONTROL)

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
Web-based video about guideline recommended exercise for lung health

Outcome Measures

Primary Outcome Measures

  1. Completion of a lung cancer screening CT scan [Within 16 weeks of enrollment]

    Completed low-dose chest CT for lung cancer screening within 16 weeks of study randomization, as determined by electronic health record review

Secondary Outcome Measures

  1. Knowledge of LCS among patients who indicate a strong preference for or against screening [Up to 16 weeks after day of enrollment]

    Mean number of lung cancer screening knowledge items answered correctly

  2. Knowledge of LCS among all patients [Up to 16 weeks after day of enrollment]

    Mean number of lung cancer screening knowledge items answered correctly

  3. Intention to receive LCS [Up to 16 weeks after day of enrollment]

    Patient intention to receive LCS as measured by a survey item

  4. Lung cancer screening decision [Up to 16 weeks after day of enrollment]

    Patient decision to receive or forego lung cancer screening in the mPATH-Lung group only

  5. Proportion of patients with LCS clinic visits scheduled [16 weeks]

    The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed

  6. Proportion of patients with LCS clinic visits completed [16 weeks]

    The proportion of patients in each arm who have completed a LCS clinic visit

  7. Proportion of patients with LCS scans ordered [16 weeks]

    The proportion of patients in each arm for whom a LCS scan was ordered

  8. Lung cancer screening test results [16 weeks]

    The results of a completed lung cancer screening CT, reported using the Lung-RADS classification

  9. Number of LCS false positives [1 year]

    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.

  10. Invasive procedures following LCS scan [1 year]

    The proportion of patients in each arm who undergo an invasive procedure following a LCS scan

  11. Proportion of patients with complications following LCS [1 year]

    The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan

  12. Overscreening [1 year]

    The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.

  13. Reach of digital outreach strategy [16 weeks]

    The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.

  14. Reach of mPATH-Lung program [16 weeks]

    The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.

  15. Acceptability of mPATH-Lung program [Up to 16 weeks after day of enrollment]

    Patient mean score on the program acceptability survey

  16. Appropriateness of mPATH-Lung program [16 weeks after the last enrolled patient]

    Primary care provider mean score on the program appropriateness survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 77 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina- Chapel Hill Chapel Hill North Carolina United States 27599
2 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27101

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: David P Miller, MD, MS, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04083859
Other Study ID Numbers:
  • IRB00060382
  • IRB00060382
  • 1R01CA237240
First Posted:
Sep 10, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Mass screening
Early detection of cancer
Digital health interventions
Decision making, computer assisted
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Aug 23, 2022