Trial Outcomes & Findings for Digital Outreach Intervention for Lung Cancer Screening (NCT NCT04083859)

Results Overview

Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26998 participants

Primary outcome timeframe

Within 16 weeks of enrollment

Results posted on

2025-06-25

Participant Flow

Participants are considered enrolled in this study when they are randomly selected by the study team to receive an invitation to use mPATH. Of the 26,909 people who were sent invitation messages, 3,267 visited the mPATH program and completed eligibility questions, and 1,333 were confirmed eligible for LCS and subsequently randomized.

Participant milestones

Participant milestones
Measure	mPATH-Lung Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program. 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.	Usual Care (CONTROL) Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit. Lung health video: Web-based video about guideline recommended exercise for lung health	Primary Care Providers Primary care providers who completed a survey about their experiences.
Overall Study STARTED	669	664	89
Overall Study COMPLETED	669	664	89
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digital Outreach Intervention for Lung Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mPATH-Lung n=669 Participants Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program. 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.	Usual Care (CONTROL) n=664 Participants Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit. Lung health video: Web-based video about guideline recommended exercise for lung health	Total n=1333 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	458 Participants n=5 Participants	483 Participants n=7 Participants	941 Participants n=5 Participants
Age, Categorical >=65 years	211 Participants n=5 Participants	181 Participants n=7 Participants	392 Participants n=5 Participants
Sex: Female, Male Female	425 Participants n=5 Participants	439 Participants n=7 Participants	864 Participants n=5 Participants
Sex: Female, Male Male	244 Participants n=5 Participants	225 Participants n=7 Participants	469 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	664 Participants n=5 Participants	651 Participants n=7 Participants	1315 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	114 Participants n=5 Participants	118 Participants n=7 Participants	232 Participants n=5 Participants
Race (NIH/OMB) White	533 Participants n=5 Participants	521 Participants n=7 Participants	1054 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 16 weeks of enrollment

Population: This population includes all participants who used the mPATH program to the point of randomization.

Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review

Outcome measures

Outcome measures
Measure	mPATH-Lung n=669 Participants Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program. 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.	Usual Care (CONTROL) n=664 Participants Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit. Lung health video: Web-based video about guideline recommended exercise for lung health
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan	164 Participants	113 Participants

SECONDARY outcome

Timeframe: Up to 16 weeks after day of enrollment

Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months after randomization

Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months after randomization

Proportion of patients who had lung cancers detected related to screening or incidentally.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months after randomization

Stage of lung cancers diagnosed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: All individuals who were sent an invitation to use the mPATH program.

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

Outcome measures

Outcome measures
Measure	mPATH-Lung n=26909 Participants Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program. 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.	Usual Care (CONTROL) Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit. Lung health video: Web-based video about guideline recommended exercise for lung health
Reach of Digital Outreach Strategy	3267 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome data not reported

Adverse Events

mPATH-Lung

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care (CONTROL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David P. Miller, Jr

Wake Forest University School of Medicine

Phone: 336-713-5218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place