Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID06605534

LEAD Pilot Study: Leveraging the Emergency Department to Address Social Determinants of Health and Reduce Lung Cancer Screening Disparities

Led by Hackensack Meridian Health · Updated on 2026-02-10

100

Participants Needed

10

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hackensack Meridian Health

Lead Sponsor

N

New Jersey Commission on Cancer Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating lung cancer screening uptake among patients aged 50 to 80 who are at risk due to smoking history. The study aims to improve lung screening knowledge, awareness, and uptake by using a Social Determinants of Health (SDoH) screening tool embedded in the Emergency Department's Electronic Health Record (EHR). This pilot Type 1 Hybrid Effectiveness-Implementation Trial will first assess the reach of this approach and then test its preliminary effectiveness compared to enhanced usual care. Participants will be randomly assigned to one of two groups. One group will use LungTalk, an interactive iPad-based educational tool tailored to smoking status and barriers, featuring audio, video, and animations to improve lung screening knowledge and beliefs. The other group will receive a non-tailored lung screening pamphlet via email and follow-up navigation support within 48 hours. Both interventions aim to encourage lung cancer screening through education and patient navigation. During the study, participants will be assessed at 1 week, 1 month, and 6 months after the intervention. Researchers will measure lung cancer screening uptake and participants' stage of adoption of lung screening. Additional assessments include health literacy, medical mistrust, perceived stigma and risk, benefits and barriers to screening, self-efficacy, knowledge about lung cancer, and fatalism. The study involves data collection from randomized trial methods and EHR records to evaluate outcomes over time.

CONDITIONS

Brief Title

Leveraging the Emergency Department (LEAD) Study

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 years to 80 years
  • Currently smoke cigarettes or quit smoking within the past 15 years
  • Have a 20 pack-year smoking history
  • Have never had lung cancer screening
  • Able to provide informed consent
  • Able to speak and understand English
Not Eligible

You will not qualify if you...

  • Diagnosed with lung cancer
  • Have a history of lung cancer screening
  • Unable to speak and understand English

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Intervention

Duration - Single session

Participants receive either the tailored LungTalk educational program via iPad or a non-tailored lung screening brochure via email with follow-up navigation support.

1 visit (in-person for LungTalk group) or electronic delivery with navigation contact within 48 hours

Follow-up Assessments

Duration - 6 months post intervention

Participants complete assessments of lung cancer screening uptake, health beliefs, and related scales at multiple timepoints after the intervention.

Assessments at 1 week, 1 month, and 6 months post intervention

Trial Site Locations

Total: 10 locations

1

Ocean Medical Center

Brick, New Jersey, United States, 08724

Actively Recruiting

2

John F. Kennedy Medical Center

Edison, New Jersey, United States, 08820

Actively Recruiting

3

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

4

Bayshore Medical Center

Holmdel, New Jersey, United States, 07733

Actively Recruiting

5

Southern Ocean Medical Center

Manahawkin, New Jersey, United States, 08050

Actively Recruiting

6

Jersey Shore University Medical Center

Neptune City, New Jersey, United States, 07753

Actively Recruiting

7

Palisades Medical Center

North Bergen, New Jersey, United States, 07047

Actively Recruiting

8

Old Bridge Medical Center

Old Bridge, New Jersey, United States, 08857

Actively Recruiting

9

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States, 08861

Actively Recruiting

10

Riverview Medical Center

Red Bank, New Jersey, United States, 07701

Actively Recruiting

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Research Team

A

Ana Guadalupe Vielma, PhD

F

Francis Valenzona

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Published Research Related To This Trial

Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement.

M Patricia Rivera, Hormuzd A Katki, Nichole T Tanner...

https://pubmed.ncbi.nlm.nih.gov/33000953

Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS).

Lisa Carter-Harris, Andy S L Tan, Ramzi G Salloum...

https://pubmed.ncbi.nlm.nih.gov/27241830

Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers.

Lisa Carter-Harris, James E Slaven, Patrick O Monahan...

https://pubmed.ncbi.nlm.nih.gov/29552458