Lung CancermPATH-LungNCT04083859
Digital Outreach Intervention for Lung Cancer Screening
A study testing mPATH-Lung and Lung health video in people with Lung Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- mPATH-Lung and Lung health video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26,998 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, 27599
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27101
About this study
Official title: A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- mPATH-Lung, Lung health video
- Keywords
- Mass screening, Early detection of cancer, Digital health interventions, Decision making, computer assisted
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPATH-LungOther
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.
Lung health videoOther
Web-based video about guideline recommended exercise for lung health
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mPATH-Lung |
| 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. Receives: Other: Lung health video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 16 weeks of enrollment
Secondary outcomes (15)
LCS Screening Decision
Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only
Measured: Up to 16 weeks after day of enrollment
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
Measured: 16 weeks
Proportion of Patients With LCS Clinic Visits Completed
The proportion of patients in each arm who have completed a LCS clinic visit
Measured: 16 weeks
Proportion of Patients With LCS Scans Ordered
The proportion of patients in each arm for whom a LCS scan was ordered
Measured: 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.
Measured: 16 weeks
Lung Cancer Screening Test Results
The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
Measured: 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.
Measured: 1 year
Invasive Procedures Following LCS Scan
The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
Measured: 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
Measured: 1 year
Number of Diagnosed Lung Cancers
Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization
Measured: 16 months after randomization
How Diagnosed Lung Cancers Were Detected
Proportion of patients who had lung cancers detected related to screening or incidentally.
Measured: 16 months after randomization
Stage of Lung Cancers Diagnosed
Stage of lung cancers diagnosed
Measured: 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.
Measured: 1 year
Reach of Digital Outreach Strategy
The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jan 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26,998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Miller, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083859
- Sponsor's protocol ID
- IRB00060382
- Other IDs
- IRB00060382, 1R01CA237240
- Acronym
- mPATH-Lung
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2019
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33532112National 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.
PubMed 21714641Pinsky PF, Church TR, Izmirlian G, Kramer BS. The National Lung Screening Trial: results stratified by demographics, smoking history, and lung cancer histology. Cancer. 2013 Nov 15;119(22):3976-83. doi: 10.1002/cncr.28326. Epub 2013 Aug 26.
PubMed 24037918Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
PubMed 24378917Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
PubMed 23315954Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.
PubMed 22710039Centers for Medicare & Medicaid Services. Final National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).; 2015. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed November 10, 2015.
Jemal A, Fedewa SA. Lung Cancer Screening With Low-Dose Computed Tomography in the United States-2010 to 2015. JAMA Oncol. 2017 Sep 1;3(9):1278-1281. doi: 10.1001/jamaoncol.2016.6416.
PubMed 28152136Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
PubMed 22610500Harris RP, Sheridan SL, Lewis CL, Barclay C, Vu MB, Kistler CE, Golin CE, DeFrank JT, Brewer NT. The harms of screening: a proposed taxonomy and application to lung cancer screening. JAMA Intern Med. 2014 Feb 1;174(2):281-5. doi: 10.1001/jamainternmed.2013.12745.
PubMed 24322781Veronesi G, Maisonneuve P, Bellomi M, Rampinelli C, Durli I, Bertolotti R, Spaggiari L. Estimating overdiagnosis in low-dose computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2012 Dec 4;157(11):776-84. doi: 10.7326/0003-4819-157-11-201212040-00005.
PubMed 23208167Patz EF Jr. Lung cancer screening, overdiagnosis bias, and reevaluation of the Mayo Lung Project. J Natl Cancer Inst. 2006 Jun 7;98(11):724-5. doi: 10.1093/jnci/djj226. No abstract available.
PubMed 16757691Kovalchik SA, Tammemagi M, Berg CD, Caporaso NE, Riley TL, Korch M, Silvestri GA, Chaturvedi AK, Katki HA. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013 Jul 18;369(3):245-254. doi: 10.1056/NEJMoa1301851.
PubMed 23863051Brenner A, Howard K, Lewis C, Sheridan S, Crutchfield T, Hawley S, Reuland D, Kistler C, Pignone M. Comparing 3 values clarification methods for colorectal cancer screening decision-making: a randomized trial in the US and Australia. J Gen Intern Med. 2014 Mar;29(3):507-13. doi: 10.1007/s11606-013-2701-0. Epub 2013 Nov 23.
PubMed 24272830Reuland DS, Cubillos L, Brenner AT, Harris RP, Minish B, Pignone MP. A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1.
PubMed 29325548
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
- ClinicalTrials.gov ID
- NCT04083859
- Acronym / sponsor ID
- mPATH-Lung / IRB00060382
- Conditions
- Lung Cancer
- Keywords
- Mass screening, Early detection of cancer, Digital health interventions, Decision making, computer assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,998 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mPATH-Lung | Experimental | Other: mPATH-LungParticipants 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 | Other: Lung health videoParticipants 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. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mPATH-LungA 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. | Other | mPATH-Lung |
| Lung health videoWeb-based video about guideline recommended exercise for lung health | Other | Usual care (CONTROL) |
Primary outcome
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
Time frame: 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
15 secondary outcomes
LCS Screening Decision
Time frame: Up to 16 weeks after day of enrollment
Proportion of Patients With LCS Clinic Visits Scheduled
Time frame: 16 weeks
Proportion of Patients With LCS Clinic Visits Completed
Time frame: 16 weeks
Proportion of Patients With LCS Scans Ordered
Time frame: 16 weeks
LCS Clinic Referral Requested Through mPATH
Time frame: 16 weeks
Lung Cancer Screening Test Results
Time frame: 16 weeks
Number of LCS False Positives
Time frame: 1 year
Invasive Procedures Following LCS Scan
Time frame: 1 year
Proportion of Patients With Complications Following LCS
Time frame: 1 year
Number of Diagnosed Lung Cancers
Time frame: 16 months after randomization
How Diagnosed Lung Cancers Were Detected
Time frame: 16 months after randomization
Stage of Lung Cancers Diagnosed
Time frame: 16 months after randomization
Overscreening
Time frame: 1 year
Reach of Digital Outreach Strategy
Time frame: 16 weeks
Completion of mPATH-Lung Program
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33532112Viale 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.
- Background: PubMed 21714641National 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.
- Background: PubMed 24037918Pinsky PF, Church TR, Izmirlian G, Kramer BS. The National Lung Screening Trial: results stratified by demographics, smoking history, and lung cancer histology. Cancer. 2013 Nov 15;119(22):3976-83. doi: 10.1002/cncr.28326. Epub 2013 Aug 26.
- Background: PubMed 24378917Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
- Background: PubMed 23315954Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
- Background: PubMed 22710039Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.
- BackgroundCenters for Medicare & Medicaid Services. Final National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).; 2015. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed November 10, 2015.
- Background: PubMed 28152136Jemal A, Fedewa SA. Lung Cancer Screening With Low-Dose Computed Tomography in the United States-2010 to 2015. JAMA Oncol. 2017 Sep 1;3(9):1278-1281. doi: 10.1001/jamaoncol.2016.6416.
- Background: PubMed 22610500Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
- Background: PubMed 24322781Harris RP, Sheridan SL, Lewis CL, Barclay C, Vu MB, Kistler CE, Golin CE, DeFrank JT, Brewer NT. The harms of screening: a proposed taxonomy and application to lung cancer screening. JAMA Intern Med. 2014 Feb 1;174(2):281-5. doi: 10.1001/jamainternmed.2013.12745.
- Background: PubMed 23208167Veronesi G, Maisonneuve P, Bellomi M, Rampinelli C, Durli I, Bertolotti R, Spaggiari L. Estimating overdiagnosis in low-dose computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2012 Dec 4;157(11):776-84. doi: 10.7326/0003-4819-157-11-201212040-00005.
- Background: PubMed 16757691Patz EF Jr. Lung cancer screening, overdiagnosis bias, and reevaluation of the Mayo Lung Project. J Natl Cancer Inst. 2006 Jun 7;98(11):724-5. doi: 10.1093/jnci/djj226. No abstract available.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Miller, MD, MS principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPATH-Lung and Lung health video in people with Lung Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan (time frame: Within 16 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083859, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.