Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB00060382 | Other Identifier | Institutional Review Board - Wake Forest University Health Science | |
| 1R01CA237240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mPATH-Lung | Experimental | 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. |
|
| Usual care (CONTROL) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPATH-Lung | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 16 weeks of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of Patients With LCS Clinic Visits Scheduled |
Not provided
Inclusion Criteria:
Meet the Medicare criteria for lung cancer screening, as updated in February 2022:
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:
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| Name | Affiliation | Role |
|---|---|---|
| David P Miller, MD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina- Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| Wake Forest Baptist Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33532112 | Background | Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available. | |
| 21714641 | Background | National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. |
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We will share de-identified individual participant data that underlie our published or presented results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
We will make the de-identified data available within one year of the publication of the relevant results. Data will remain available for at least 5 years from the last publication of results.
Researchers desiring data access must provide a methodologically sound proposal to the study principal investigator. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | Primary Care Providers | Primary care providers who completed a survey about their experiences. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who were determined to be eligible for LCS based on their responses to initial questions in the mPATH program were randomized into either the intervention or enhanced usual care arm. No baseline characteristics were collected for participants in the "Primary Care Providers" arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This population includes all participants who used the mPATH program to the point of randomization. | Posted | Count of Participants | Participants | Within 16 weeks of enrollment |
|
1 year
No adverse event details were collected for participants in the "Primary Care Providers" arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David P. Miller, Jr | Wake Forest University School of Medicine | 336-713-5218 | dmiller@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2025 | Jun 17, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2023 | May 28, 2025 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
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Not provided
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| Lung health video | Other | Web-based video about guideline recommended exercise for lung health |
|
The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed
| 16 weeks |
| Proportion of Patients With LCS Clinic Visits Completed | The proportion of patients in each arm who have completed a LCS clinic visit | 16 weeks |
| Proportion of Patients With LCS Scans Ordered | The proportion of patients in each arm for whom a LCS scan was ordered | 16 weeks |
| 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 |
| Lung Cancer Screening Test Results | The results of a completed lung cancer screening CT, reported using the Lung-RADS classification | 16 weeks |
| 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 |
| Invasive Procedures Following LCS Scan | The proportion of patients in each arm who undergo an invasive procedure following a LCS scan | 1 year |
| 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 |
| Number of Diagnosed Lung Cancers | Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization | 16 months after randomization |
| How Diagnosed Lung Cancers Were Detected | Proportion of patients who had lung cancers detected related to screening or incidentally. | 16 months after randomization |
| Stage of Lung Cancers Diagnosed | Stage of lung cancers diagnosed | 16 months after randomization |
| 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 |
| Reach of Digital Outreach Strategy | The proportion of patients sent a digital invitation who complete the eligibility questions on the study website. | 16 weeks |
| 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 |
| Winston-Salem |
| North Carolina |
| 27101 |
| United States |
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| 30622199 | Background | Henderson LM, Marsh MW, Benefield TS, Jones LM, Reuland DS, Brenner AT, Goldstein AO, Molina PL, Maygarden SJ, Rivera MP. Opinions and Practices of Lung Cancer Screening by Physician Specialty. N C Med J. 2019 Jan-Feb;80(1):19-26. doi: 10.18043/ncm.80.1.19. |
| 41114973 | Derived | Miller DP, Snavely AC, Dharod A, Brenner AT, Wright E, Stradtman L, Bellinger CR, Bundy R, Volk RJ, Hamburger E, Ferrari RM, Randazzo A, Reuland DS. A Direct-to-Patient Digital Health Program for Lung Cancer Screening: A Randomized Clinical Trial. JAMA. 2025 Nov 25;334(20):1807-1815. doi: 10.1001/jama.2025.17281. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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 |
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| Secondary | LCS Screening Decision | Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only | Not Posted | Up to 16 weeks after day of enrollment | Participants |
| 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 | Not Posted | 16 weeks | Participants |
| Secondary | Proportion of Patients With LCS Clinic Visits Completed | The proportion of patients in each arm who have completed a LCS clinic visit | Not Posted | 16 weeks | Participants |
| Secondary | Proportion of Patients With LCS Scans Ordered | The proportion of patients in each arm for whom a LCS scan was ordered | Not Posted | 16 weeks | Participants |
| Secondary | LCS Clinic Referral Requested Through mPATH | The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment. | Not Posted | 16 weeks | Participants |
| Secondary | Lung Cancer Screening Test Results | The results of a completed lung cancer screening CT, reported using the Lung-RADS classification | Not Posted | 16 weeks | Participants |
| 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. | Not Posted | 1 year | Participants |
| Secondary | Invasive Procedures Following LCS Scan | The proportion of patients in each arm who undergo an invasive procedure following a LCS scan | Not Posted | 1 year | Participants |
| 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 | Not Posted | 1 year | Participants |
| Secondary | Number of Diagnosed Lung Cancers | Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization | Not Posted | 16 months after randomization | Participants |
| Secondary | How Diagnosed Lung Cancers Were Detected | Proportion of patients who had lung cancers detected related to screening or incidentally. | Not Posted | 16 months after randomization | Participants |
| Secondary | Stage of Lung Cancers Diagnosed | Stage of lung cancers diagnosed | Not Posted | 16 months after randomization | Participants |
| Secondary | Overscreening | The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review. | Not Posted | 1 year | Participants |
| Secondary | Reach of Digital Outreach Strategy | The proportion of patients sent a digital invitation who complete the eligibility questions on the study website. | All individuals who were sent an invitation to use the mPATH program. | Posted | Count of Participants | Participants | 16 weeks |
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| 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. | Not Posted | 16 weeks | Participants |
| 0 |
| 669 |
| 0 |
| 669 |
| 0 |
| 669 |
| EG001 | 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 | 0 | 664 | 0 | 664 | 0 | 664 |
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |