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Clinical Trials/NCT04675476
NCT04675476RecruitingNot Applicable

A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening

Georgetown University1 site in 1 country368 target enrollmentStarted: March 11, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
368
Locations
1
Primary Endpoint
provider-patient discussion

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
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

  • •Individuals with a history of lung cancer

Arms & Interventions

Multilevel Intervention

Experimental

Intervention: Provider Prompt & Patient Outreach and Education (Behavioral)

Nonequivalent Control Group

No Intervention

Outcomes

Primary Outcomes

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 knowledge

Time Frame: 1-week post-visit

Lung cancer screening knowledge measure

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?')

Secondary Outcomes

  • lung cancer screening completion rates(6-months)
  • lung cancer screening referrals(6-months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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