Lung Cancer
Conditions
Keywords
Mass screening, Early detection of cancer, Digital health interventions, Decision making, computer assisted
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.
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
Interventions
OTHERmPATH-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.
OTHERLung health video
Web-based video about guideline recommended exercise for lung health
Sponsors
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan | Within 16 weeks of enrollment | Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Proportion of Patients With LCS Clinic Visits Completed | 16 weeks | The proportion of patients in each arm who have completed a LCS clinic visit |
| Proportion of Patients With LCS Scans Ordered | 16 weeks | The proportion of patients in each arm for whom a LCS scan was ordered |
| LCS Clinic Referral Requested Through mPATH | 16 weeks | The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment. |
| Lung Cancer Screening Test Results | 16 weeks | The results of a completed lung cancer screening CT, reported using the Lung-RADS classification |
| 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. |
| Invasive Procedures Following LCS Scan | 1 year | The proportion of patients in each arm who undergo an invasive procedure following a LCS scan |
| LCS Screening Decision | 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 |
| Number of Diagnosed Lung Cancers | 16 months after randomization | Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization |
| How Diagnosed Lung Cancers Were Detected | 16 months after randomization | Proportion of patients who had lung cancers detected related to screening or incidentally. |
| Stage of Lung Cancers Diagnosed | 16 months after randomization | Stage of lung cancers diagnosed |
| 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. |
| Reach of Digital Outreach Strategy | 16 weeks | The proportion of patients sent a digital invitation who complete the eligibility questions on the study website. |
| Completion 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. |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 669 |
| 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 | 664 |
| Total | 1,333 |
Baseline characteristics
| Characteristic | mPATH-Lung | Usual Care (CONTROL) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 211 Participants | 181 Participants | 392 Participants |
| Age, Categorical Between 18 and 65 years | 458 Participants | 483 Participants | 941 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 13 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 664 Participants | 651 Participants | 1315 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 114 Participants | 118 Participants | 232 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 25 Participants | 47 Participants |
| Race (NIH/OMB) White | 533 Participants | 521 Participants | 1054 Participants |
| Sex: Female, Male Female | 425 Participants | 439 Participants | 864 Participants |
| Sex: Female, Male Male | 244 Participants | 225 Participants | 469 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 669 | 0 / 664 |
| other Total, other adverse events | 0 / 669 | 0 / 664 |
| serious Total, serious adverse events | 0 / 669 | 0 / 664 |
Outcome results
Primary
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
Time frame: Within 16 weeks of enrollment
Population: This population includes all participants who used the mPATH program to the point of randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mPATH-Lung | Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan | 164 Participants |
| Usual Care (CONTROL) | Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan | 113 Participants |
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.
Time frame: 16 weeks
Secondary
How Diagnosed Lung Cancers Were Detected
Proportion of patients who had lung cancers detected related to screening or incidentally.
Time frame: 16 months after randomization
Secondary
Invasive Procedures Following LCS Scan
The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
Time frame: 1 year
Secondary
LCS Clinic Referral Requested Through mPATH
The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.
Time frame: 16 weeks
Secondary
LCS Screening Decision
Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only
Time frame: Up to 16 weeks after day of enrollment
Secondary
Lung Cancer Screening Test Results
The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
Time frame: 16 weeks
Secondary
Number of Diagnosed Lung Cancers
Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization
Time frame: 16 months after randomization
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.
Time frame: 1 year
Secondary
Overscreening
The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.
Time frame: 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
Time frame: 1 year
Secondary
Proportion of Patients With LCS Clinic Visits Completed
The proportion of patients in each arm who have completed a LCS clinic visit
Time frame: 16 weeks
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
Time frame: 16 weeks
Secondary
Proportion of Patients With LCS Scans Ordered
The proportion of patients in each arm for whom a LCS scan was ordered
Time frame: 16 weeks
Secondary
Reach of Digital Outreach Strategy
The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
Time frame: 16 weeks
Population: All individuals who were sent an invitation to use the mPATH program.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mPATH-Lung | Reach of Digital Outreach Strategy | 3267 Participants |
Secondary
Stage of Lung Cancers Diagnosed
Stage of lung cancers diagnosed
Time frame: 16 months after randomization