Lung CancerNCT04806399
Improving Utilization of Lung Cancer Screening in Underserved PA Populations
A study testing Educational Materials and Decision Counseling in people with Lung Cancer, run by American College of Radiology at 2 sites in United States.
Trial summary
This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths. 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?
- Educational Materials and Decision Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,572 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have an upcoming office visit with a primary care physician in one of the study practices
- Between the ages of 50 and 77 (inclusive)
- History of smoking (current or former) in the electronic medical record (EMR)
Who cannot join
- Chest CT performed in the last 10 months before study initiation according to EMR
- Diagnosis of lung cancer indicated in the problem list in the EMR
- Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105
Jefferson Health System
Philadelphia, Pennsylvania, 19107
About this study
This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.
Read the detailed description
The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.
- Conditions
- Lung Cancer
- Being tested
- Educational Materials and Decision Counseling
- Keywords
- Screening Utilization
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials and Decision CounselingOther
Participants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control Group | No intervention | Not described |
| Outreach Contact with Decision Counseling Group | Active comparator | Not described Receives: Other: Educational Materials and Decision Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start30 Mar 2023
- Primary completion31 Jul 2024
- Study completion30 Nov 2024
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.
- 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
- Model description
- Participants will be randomly selected for assignment to the Outreach Contact with Decision Counseling Group or randomly selected for assignment to a Usual Care Control Group
- Masking
- None (open label)
- Enrolment
- 2,572 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Etta Pisano, MD, Principal investigator, American College of RadiologyRonald Myers, PhD, Study chair, Jefferson Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806399
- Sponsor's protocol ID
- Cure 16
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2021
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Utilization of Lung Cancer Screening in Underserved PA Populations
- ClinicalTrials.gov ID
- NCT04806399
- Acronym / sponsor ID
- Cure 16
- Conditions
- Lung Cancer
- Keywords
- Screening Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,572 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Mar 2021 (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 study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.
Detailed description
The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly selected for assignment to the Outreach Contact with Decision Counseling Group or randomly selected for assignment to a Usual Care Control Group
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control Group | No intervention | – |
| Outreach Contact with Decision Counseling Group | Active comparator | Other: Educational Materials and Decision Counseling |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have an upcoming office visit with a primary care physician in one of the study practices
- Between the ages of 50 and 77 (inclusive)
- History of smoking (current or former) in the electronic medical record (EMR)
Key exclusion criteria (3 listed)
- Chest CT performed in the last 10 months before study initiation according to EMR
- Diagnosis of lung cancer indicated in the problem list in the EMR
- Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)
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 |
|---|---|---|
| Educational Materials and Decision CounselingParticipants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials. | Other | Outreach Contact with Decision Counseling Group |
Primary outcome
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
Time frame: 24 months
Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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. This study is not recruiting at the moment.
Etta Pisano, MD principal investigator
American College of Radiology
Ronald Myers, PhD study chair
Jefferson Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials and Decision Counseling in people with Lung Cancer, run by American College of Radiology 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 3 inclusion and 3 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 28 Oct 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care. (time frame: 24 months). 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 28 Oct 2026.