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Active, not recruitingNCT04675476Updated Oct 7, 2026

A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

An interventional study of Provider Prompt & Patient Outreach and Education in Lung Cancer, sponsored by Georgetown University. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Georgetown University · Not applicable, Interventional, and Screening

Updated Oct 7, 2026Now Active, not recruitingPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
368
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 368 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Individuals with a history of lung cancer
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
368 participants (estimated)

Study arms

  • Experimental
    Multilevel Intervention

    Behavioral: Provider Prompt & Patient Outreach and Education

  • No intervention
    Nonequivalent Control Group

Interventions

  • BehavioralProvider Prompt & Patient Outreach and Education

    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.

06

What researchers measure

Primary outcomes

  1. provider-patient discussion

    Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')

    Time frame: 1-week post-visit

  2. lung cancer screening intentions

    Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')

    Time frame: 1-week post-visit

  3. lung cancer screening knowledge

    Lung cancer screening knowledge measure

    Time frame: 1-week post-visit

Secondary outcomes

  1. lung cancer screening referrals

    Total number of lung screening orders captured via the electronic medical record

    Time frame: 6-months

  2. lung cancer screening completion rates

    Total number of lung screening completions captured via the electronic medical record

    Time frame: 6-months

07

Study locations

1 site
  • MedStar Health
    Washington D.C., District of Columbia 20007, United States
08

References and documents

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 40231692 ↗
  • Williams 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 7, 2026
Sites
1 site added, 1 site removed
Show site
  • MedStar Health · Washington D.C., United States
Show 1 removed
  • MedStar Health · Washington, United States
Oct 7, 2026
Primary completion
Dec 31, 2025→Dec 31, 2026
Oct 7, 2026
Study completion
Feb 28, 2026→Feb 28, 2027
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Recruiting→Active, not recruiting
    1 site added, 1 site removed
    Show site
    • MedStar Health · Washington D.C., United States
    Show 1 removed
    • MedStar Health · Washington, United States
    Primary completion Dec 31, 2025→Dec 31, 2026
    Study completion Feb 28, 2026→Feb 28, 2027
    + 4 other changes: verification date, contact details, references and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04675476
Lead sponsor
Georgetown University
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Mar 11, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Oct 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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