NCT06605534 Leveraging the Emergency Department (LEAD) Study
| NCT ID | NCT06605534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hackensack Meridian Health |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-10-29 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.
Eligibility Criteria
Inclusion Criteria: * Aged 50 years to 80 years * Currently smoke cigarettes or quit smoking cigarettes within the past 15 years * 20 pack-year smoking history * Has never had lung cancer screening * Able to provide informed consent * Able to speak and understand English Exclusion Criteria: * Diagnosed with lung cancer * Has a history of having a lung cancer screening scan * Unable to speak and understand English
Contact & Investigator
Lisa Carter-Bawa, PhD
PRINCIPAL INVESTIGATOR
Hackensack Meridian Health
Frequently Asked Questions
Who can join the NCT06605534 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06605534 currently recruiting?
Yes, NCT06605534 is actively recruiting participants. Contact the research team at ana.vielma@hmh-cdi.org for enrollment information.
Where is the NCT06605534 trial being conducted?
This trial is being conducted at Brick, United States, Edison, United States, Hackensack, United States, Holmdel, United States and 6 additional locations.
Who is sponsoring the NCT06605534 clinical trial?
NCT06605534 is sponsored by Hackensack Meridian Health. The principal investigator is Lisa Carter-Bawa, PhD at Hackensack Meridian Health. The trial plans to enroll 100 participants.
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