Lung CancerNCT07322367
A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients
A study testing Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages and Portal message only in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. Read more about this study
- Who is it for?
- Ages 50 to 77 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages and Portal message only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will:
- 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 established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days).
- Have a patient portal account or cellphone number listed in the electronic health record
- Have a North Carolina address listed in the electronic health record
Who cannot join
- The following patients will be excluded:
- Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)
- Those for whom lung cancer screening would be or may be inappropriate:
- electronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure exclusion criteria based on significant comorbidities and/or frailty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Study Coordinator, MD, 704-355-2000, Aliza.randazzo@advocatehealth.org
Study Coordinator
About this study
Official title: A Pragmatic Randomized-Controlled Learning Health System Trial
To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.
Read the detailed description
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.
Secondary Objectives
- Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups.
- Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care.
- Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria
- Conditions
- Lung Cancer
- Being tested
- Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages, Portal message only, Usual Care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal Message with Reminder Text MessagesOther
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder if they start the mPATH-Lung program but do not complete it.
If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.
Text Message with Reminder Text MessagesOther
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder.
If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.
Portal message onlyOther
Participant will only receive portal message with no reminder text messages.
Usual CareOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patient portal message first followed by up to 3 reminder text messages. Receives: Other: Portal Message with Reminder Text Messages |
| Arm B | Experimental | Text message only with up to 3 reminder text messages. Receives: Other: Text Message with Reminder Text Messages |
| Arm C | Experimental | Portal message only with no reminder messages. Receives: Other: Portal message only |
| Usual Care Arm | Active comparator | Patients receive usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants to Complete Lung Screening CT - Primary Effectiveness
Completion of the lung screening CT by participants.
Measured: 90 days
Secondary outcomes (5)
Number of Participants with Eligibility for Lung Screening
Reach of the mPATH-Lung platform, defined as the participants who determine their eligibility for lung screening within the mPATH-Lung program within 90 days of the first invitation. Investigators will determine reach overall, within subgroups, and within study arms.
Measured: 90 days
Number of Requests for Lung Screening
Requests for lung screening within the mPATH-Lung program
Measured: 90 days
Number of Orders for Lung Screening CT Scans
Orders for lung screening CT scans for participants in study arms
Measured: Within 90 days of randomization
Amount of Revenue Generated
Revenue (costs) generated from lung cancer screening and follow-up care.
Measured: 12 months following completion of screenings
Number of Participants that Represent Over-screening
Among patients with newly diagnosed lung cancer by lung screening, the participants that represent over-screening, defined as a patient being deemed too ill for potentially curative surgery on blinded chart review.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start25 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brent Heideman, Jr., MD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322367
- Sponsor's protocol ID
- IRB00139213
- Other IDs
- P30CA012197
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized-Controlled Learning Health System Trial
- ClinicalTrials.gov ID
- NCT07322367
- Acronym / sponsor ID
- IRB00139213
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27,000 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.
Detailed description
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.
Secondary Objectives
- Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups.
- Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care.
- Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Portal Message with Reminder Text MessagesPatient portal message first followed by up to 3 reminder text messages. |
| Arm B | Experimental | Other: Text Message with Reminder Text MessagesText message only with up to 3 reminder text messages. |
| Arm C | Experimental | Other: Portal message onlyPortal message only with no reminder messages. |
| Usual Care Arm | Active comparator | Other: Usual CarePatients receive usual care. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days).
Key exclusion criteria (4 listed)
- Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)
- Those for whom lung cancer screening would be or may be inappropriate:
- electronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure exclusion criteria based on significant comorbidities and/or frailty.
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 |
|---|---|---|
| Portal Message with Reminder Text MessagesIf the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder if they start the mPATH-Lung program but do not complete it. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder. | Other | Arm A |
| Text Message with Reminder Text MessagesIf the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder. | Other | Arm B |
| Portal message onlyParticipant will only receive portal message with no reminder text messages. | Other | Arm C |
| Usual CareStandard of care | Other | Usual Care Arm |
Primary outcome
Number of Participants to Complete Lung Screening CT - Primary Effectiveness
Time frame: 90 days
Completion of the lung screening CT by participants.
5 secondary outcomes
Number of Participants with Eligibility for Lung Screening
Time frame: 90 days
Number of Requests for Lung Screening
Time frame: 90 days
Number of Orders for Lung Screening CT Scans
Time frame: Within 90 days of randomization
Amount of Revenue Generated
Time frame: 12 months following completion of screenings
Number of Participants that Represent Over-screening
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Brent Heideman, Jr., MD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages and Portal message only in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (704-355-2000, Aliza.randazzo@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Complete Lung Screening CT - Primary Effectiveness (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.