Lung CancerNCT04675476
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
A study testing Provider Prompt & Patient Outreach and Education in people with Lung Cancer, run by Georgetown University at 1 site in United States.
Trial summary
To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Provider Prompt & Patient Outreach and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 28 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-80 years old;
- current cigarette smoker or quit within 15 years;
- a 20+ pack-year smoking history;
- non-adherent to lung screening (>13 months);
- English-speaking;
- scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
- able and willing to provide meaningful consent and complete telephone interviews
Who cannot join
- Individuals with a history of lung cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Health
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening
To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.
Read the detailed description
The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.
- Conditions
- Lung Cancer
- Being tested
- Provider Prompt & Patient Outreach and Education
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Prompt & Patient Outreach and EducationBehavioural
To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Intervention | Experimental | Not described Receives: Behavioral: Provider Prompt & Patient Outreach and Education |
| Nonequivalent Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
provider-patient discussion
Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')
Measured: 1-week post-visit
lung cancer screening intentions
Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')
Measured: 1-week post-visit
lung cancer screening knowledge
Lung cancer screening knowledge measure
Measured: 1-week post-visit
Secondary outcomes (2)
lung cancer screening referrals
Total number of lung screening orders captured via the electronic medical record
Measured: 6-months
lung cancer screening completion rates
Total number of lung screening completions captured via the electronic medical record
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start11 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Georgetown UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675476
- Sponsor's protocol ID
- STUDY00003277
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Williams RM, Whealan J, Sangraula A, Taylor KL, Adams-Campbell L, Miller KE, Glassmeyer K, Yee P, Camidge K, Foley K, Luta G, Lin KW, Barnes R, DuBoyce WF. Providing Reminders and Education Prior to lung cancer screening: Feasibility and acceptability of a multilevel approach to address disparities in lung cancer screening. Transl Behav Med. 2025 Jan 16;15(1):ibaf008. doi: 10.1093/tbm/ibaf008.
PubMed 40231692Williams RM, Whealan J, Taylor KL, Adams-Campbell L, Miller KE, Foley K, Luta G, Brandt H, Glassmeyer K, Sangraula A, Yee P, Camidge K, Blumenthal J, Modi S, Kratz H. Multilevel approaches to address disparities in lung cancer screening: a study protocol. Implement Sci Commun. 2024 Feb 16;5(1):15. doi: 10.1186/s43058-024-00553-4.
PubMed 38365820
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT04675476
- Acronym / sponsor ID
- STUDY00003277
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Dec 2020 (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 test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.
Detailed description
The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multilevel Intervention | Experimental | Behavioral: Provider Prompt & Patient Outreach and Education |
| Nonequivalent Control Group | No intervention | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50-80 years old;
- current cigarette smoker or quit within 15 years;
- a 20+ pack-year smoking history;
- non-adherent to lung screening (>13 months);
- English-speaking;
Key exclusion criteria (1 listed)
- Individuals with a history of lung cancer
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 |
|---|---|---|
| Provider Prompt & Patient Outreach and EducationTo target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit. | Behavioural | Multilevel Intervention |
Primary outcome
provider-patient discussion
Time frame: 1-week post-visit
Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')
lung cancer screening intentions
Time frame: 1-week post-visit
Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')
lung cancer screening knowledge
Time frame: 1-week post-visit
Lung cancer screening knowledge measure
2 secondary outcomes
lung cancer screening referrals
Time frame: 6-months
lung cancer screening completion rates
Time frame: 6-months
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 7 Oct 2026.
- Derived from this study: PubMed 40231692Williams RM, Whealan J, Sangraula A, Taylor KL, Adams-Campbell L, Miller KE, Glassmeyer K, Yee P, Camidge K, Foley K, Luta G, Lin KW, Barnes R, DuBoyce WF. Providing Reminders and Education Prior to lung cancer screening: Feasibility and acceptability of a multilevel approach to address disparities in lung cancer screening. Transl Behav Med. 2025 Jan 16;15(1):ibaf008. doi: 10.1093/tbm/ibaf008.
- Derived from this study: PubMed 38365820Williams RM, Whealan J, Taylor KL, Adams-Campbell L, Miller KE, Foley K, Luta G, Brandt H, Glassmeyer K, Sangraula A, Yee P, Camidge K, Blumenthal J, Modi S, Kratz H. Multilevel approaches to address disparities in lung cancer screening: a study protocol. Implement Sci Commun. 2024 Feb 16;5(1):15. doi: 10.1186/s43058-024-00553-4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Prompt & Patient Outreach and Education in people with Lung Cancer, run by Georgetown University 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 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 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?
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?
provider-patient discussion (time frame: 1-week post-visit). The study lists 3 primary outcomes in all. 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 NCT04675476, which also lists 2 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 7 Oct 2026.