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Recruiting NCT04675476

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

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Provider Prompt & Patient Outreach and Education.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening

Overview

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.

Interventions

  • Behavioral Provider 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

Primary outcome measures

  • provider-patient discussion [Time frame: 1-week post-visit]
  • lung cancer screening intentions [Time frame: 1-week post-visit]
  • lung cancer screening knowledge [Time frame: 1-week post-visit]
Secondary outcome measures (2)
  • lung cancer screening referrals [Time frame: 6-months]
  • lung cancer screening completion rates [Time frame: 6-months]

Eligibility criteria

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

  • Individuals with a history of lung cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • MedStar Health — Washington D.C.

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. PMID 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. PMID 38365820

Identifiers

NCT: NCT04675476 · STUDY00003277

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗