Lung CarcinomaNCT05679349
Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking
A study testing Survey Administration, Educational Activity and Electronic Health Record Review in people with Lung Carcinoma and Tobacco-Related Carcinoma, run by Ronald Myers at 1 site in United States.
Trial summary
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma, Tobacco-Related Carcinoma
- What is being tested?
- Survey Administration, Educational Activity and Electronic Health Record Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 26 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PRACTICE LEVEL:
- Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
- Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
- Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
- PATIENT LEVEL:
- Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
Show all 10Show fewer
- 50 to 77 years of age
- Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
- Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
- Able to communicate in English or Spanish (determined at baseline eligibility assessment)
Who cannot join
- PATIENT OUTREACH:
- Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
- G0297 - LDCT screening
- 71250 - CT w/o contrast
- 71260 - CT w/ contrast
- 71270 - CT with and w/o contrast
Show all 12Show fewer
- 71275 - CT angiography chest
- 78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
- 78816 - PET CT whole body
- Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
- Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
- Dementia (diagnosis codes F03.90 or F03.91) in EHR
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
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Ronald Myers
About this study
Official title: Provider Support and Patient Outreach in Lung Cancer Screening
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).
SECONDARY OBJECTIVES:
- Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.
EXPLORATORY OBJECTIVES:
- Assess intervention impact on:
Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.
OUTLINE: In accordance with the 2X2 cluster randomized design, primary care practices along with providers initially are randomized to 1 of 2 groups. Then, patients within the practices are randomized to 1 of 2 groups.
PROVIDERS:
GROUP A: PROVIDER SUPPORT GROUP: Providers complete baseline and endpoint surveys once on study. Providers also undergo online educational activity on study. Participants undergo distance learning on study.
GROUP B: PROVIDER CONTROL GROUP: Participants complete baseline and endpoint surveys once on study.
PATIENTS:
GROUP A: PROVIDER SUPPORT + PATIENT OUTREACH GROUP: Providers receive support once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
GROUP B: PROVIDER SUPPORT + PATIENT CONTROL GROUP: Providers receive support once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
GROUP C: PROVIDER CONTROL + PATIENT OUTREACH GROUP: Providers receive usual care once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
Group D: PROVIDER CONTROL + PATIENT CONTROL GROUP: Providers receive usual care once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
- Conditions
- Lung Carcinoma, Tobacco-Related Carcinoma
- Being tested
- Survey Administration, Educational Activity, Electronic Health Record Review, Counseling
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
Educational ActivityOther
Undergo online shared decision making training and distance learning
Survey AdministrationOther
Complete survey
Electronic Health Record ReviewOther
Undergo electronic health record review
Educational ActivityOther
Undergo online shared decision making training and distance learning
CounselingOther
Also called Counseling Intervention
Undergo shared decision making counseling
Survey AdministrationOther
Complete survey
Electronic Health Record ReviewOther
Undergo electronic health record review
| Study group | Role | What they receive |
|---|---|---|
| Group A (Providers): (survey, online educational activity) | Experimental | Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study. Receives: Other: Survey Administration; Other: Educational Activity |
| Group B (Providers): (survey) | Active comparator | Participants complete survey at baseline and end of study survey. Receives: Other: Survey Administration |
| Group A (Patients): (EHR, educational activity, counseling)) | Experimental | Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study. Receives: Other: Electronic Health Record Review; Other: Educational Activity; Other: Counseling |
| Group B (Patients): (survey) | Active comparator | Patients undergo EHR review on study and complete telephone survey throughout the trial. Receives: Other: Survey Administration; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of initial lung cancer screening (LCS)
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
Measured: Within 4 months of randomization
Secondary outcomes (4)
Referral for LCS
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
Measured: Up to 5 years
Tobacco cessation services
Referrals for tobacco treatment services will be found by reviewing medical records.
Measured: Up to 5 years
Repeat annual lung cancer screenings within 11-16 months of original screening
Number of repeat screenings will be found by reviewing electronic medical records.
Measured: within 11-16 months of original screening
Diagnostic follow up after initial lung cancer screening
Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.
Measured: Up to 4 months of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Apr 2024
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 822 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ronald Myers
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Ronald Myers, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679349
- Sponsor's protocol ID
- 22F.808
- Other IDs
- R01CA258849, JT 24704
- Status last verified
- May 2026
- First submitted
- 23 Dec 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Support and Patient Outreach in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT05679349
- Acronym / sponsor ID
- 22F.808
- Conditions
- Lung Carcinoma, Tobacco-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 822 participants (estimated)
- Lead sponsor
- Ronald MyersUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 11 Jan 2023 (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.
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.
Detailed description
PRIMARY OBJECTIVES:
- Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).
SECONDARY OBJECTIVES:
- Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.
EXPLORATORY OBJECTIVES:
- Assess intervention impact on:
Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.
OUTLINE: In accordance with the 2X2 cluster randomized design, primary care practices along with providers initially are randomized to 1 of 2 groups. Then, patients within the practices are randomized to 1 of 2 groups.
PROVIDERS:
GROUP A: PROVIDER SUPPORT GROUP: Providers complete baseline and endpoint surveys once on study. Providers also undergo online educational activity on study. Participants undergo distance learning on study.
GROUP B: PROVIDER CONTROL GROUP: Participants complete baseline and endpoint surveys once on study.
PATIENTS:
GROUP A: PROVIDER SUPPORT + PATIENT OUTREACH GROUP: Providers receive support once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
GROUP B: PROVIDER SUPPORT + PATIENT CONTROL GROUP: Providers receive support once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
GROUP C: PROVIDER CONTROL + PATIENT OUTREACH GROUP: Providers receive usual care once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.
Group D: PROVIDER CONTROL + PATIENT CONTROL GROUP: Providers receive usual care once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (Providers): (survey, online educational activity) | Experimental | Other: Survey Administration, Other: Educational ActivityParticipants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study. |
| Group B (Providers): (survey) | Active comparator | Other: Survey AdministrationParticipants complete survey at baseline and end of study survey. |
| Group A (Patients): (EHR, educational activity, counseling)) | Experimental | Other: Electronic Health Record Review, Other: Educational Activity, Other: CounselingPatients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study. |
| Group B (Patients): (survey) | Active comparator | Other: Survey Administration, Other: Electronic Health Record ReviewPatients undergo EHR review on study and complete telephone survey throughout the trial. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PRACTICE LEVEL:
- Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
- Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
- Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
- PATIENT LEVEL:
Key exclusion criteria (12 listed)
- PATIENT OUTREACH:
- Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
- Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
- Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
- Dementia (diagnosis codes F03.90 or F03.91) in EHR
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 |
|---|---|---|
| Survey AdministrationComplete survey | Other | Group A (Providers): (survey, online educational activity) |
| Educational ActivityUndergo online shared decision making training and distance learning | Other | Group A (Providers): (survey, online educational activity) |
| Survey AdministrationComplete survey | Other | Group B (Providers): (survey) |
| Electronic Health Record ReviewUndergo electronic health record review | Other | Group A (Patients): (EHR, educational activity, counseling)) |
| Educational ActivityUndergo online shared decision making training and distance learning | Other | Group A (Patients): (EHR, educational activity, counseling)) |
| CounselingAlso: Counseling InterventionUndergo shared decision making counseling | Other | Group A (Patients): (EHR, educational activity, counseling)) |
| Survey AdministrationComplete survey | Other | Group B (Patients): (survey) |
| Electronic Health Record ReviewUndergo electronic health record review | Other | Group B (Patients): (survey) |
Primary outcome
Completion of initial lung cancer screening (LCS)
Time frame: Within 4 months of randomization
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
4 secondary outcomes
Referral for LCS
Time frame: Up to 5 years
Tobacco cessation services
Time frame: Up to 5 years
Repeat annual lung cancer screenings within 11-16 months of original screening
Time frame: within 11-16 months of original screening
Diagnostic follow up after initial lung cancer screening
Time frame: Up to 4 months of screening
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 29 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration, Educational Activity and Electronic Health Record Review in people with Lung Carcinoma and Tobacco-Related Carcinoma, run by Ronald Myers 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 10 inclusion and 12 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 29 May 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 Ronald Myers, PhD (215-503-4085, ronald.myers@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of initial lung cancer screening (LCS) (time frame: Within 4 months of randomization). 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 29 May 2026.