Digital Outreach Intervention for Lung Cancer Screening (mPATH-Lung)
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|ClinicalTrials.gov Identifier: NCT04083859|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : June 26, 2020
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|
|Lung Cancer||Other: mPATH-Lung Other: Lung health video||Not Applicable|
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.
- 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 60 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2024|
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.
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
- Completion of a lung cancer screening CT scan [ Time Frame: 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
- Knowledge of LCS among patients who indicate a strong preference for or against screening [ Time Frame: Up to 16 weeks after day of enrollment ]Mean number of lung cancer screening knowledge items answered correctly
- Knowledge of LCS among all patients [ Time Frame: Up to 16 weeks after day of enrollment ]Mean number of lung cancer screening knowledge items answered correctly
- Intention to receive LCS [ Time Frame: Up to 16 weeks after day of enrollment ]Patient intention to receive LCS as measured by a survey item
- Lung cancer screening decision [ Time Frame: Up to 16 weeks after day of enrollment ]Patient decision to receive or forego lung cancer screening in the mPATH-Lung group only
- Proportion of patients with LCS clinic visits scheduled [ Time Frame: 16 weeks ]The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed
- Proportion of patients with LCS clinic visits completed [ Time Frame: 16 weeks ]The proportion of patients in each arm who have completed a LCS clinic visit
- Proportion of patients with LCS scans ordered [ Time Frame: 16 weeks ]The proportion of patients in each arm for whom a LCS scan was ordered
- Lung cancer screening test results [ Time Frame: 16 weeks ]The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
- Number of LCS false positives [ Time Frame: 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.
- Invasive procedures following LCS scan [ Time Frame: 1 year ]The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
- Proportion of patients with complications following LCS [ Time Frame: 1 year ]The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan
- Overscreening [ Time Frame: 1 year ]The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.
- Reach of digital outreach strategy [ Time Frame: 16 weeks ]The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
- Reach of mPATH-Lung program [ Time Frame: 16 weeks ]The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.
- Acceptability of mPATH-Lung program [ Time Frame: Up to 16 weeks after day of enrollment ]Patient mean score on the program acceptability survey
- Appropriateness of mPATH-Lung program [ Time Frame: 16 weeks after the last enrolled patient ]Primary care provider mean score on the program appropriateness survey
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083859
|Contact: Diana E Floresemail@example.com|
|United States, North Carolina|
|University of North Carolina- Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Teri L Malo 919-445-6217 firstname.lastname@example.org|
|Principal Investigator: Alison T Brenner, PhD|
|Sub-Investigator: Dan Reuland, MD|
|Sub-Investigator: Arlene Chung, MD|
|Sub-Investigator: Teri L Malo, PhD|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27101|
|Contact: Diana E Flores 336-713-3103 email@example.com|
|Principal Investigator: David P Miller, MD, MS|
|Sub-Investigator: Kristie Foley, PhD|
|Sub-Investigator: Ajay Dharod, MD|
|Sub-Investigator: Christina Bellinger, MD|
|Principal Investigator:||David P Miller, MD, MS||Wake Forest University Health Sciences|