Recruiting

Observational Study

Sponsor:

Hackensack Meridian Health

Code:

NCT06605534

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

LungTalk

Non-tailored lung screening

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT06605534

Start date

Oct 29, 2024

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: LungTalk Group

LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03.

active comparator: Non-tailored Lung Screening Pamphlet Group

Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.

Interventions

LungTalk

Tailored lung screening intervention

Non-tailored lung screening

Non-tailored lung screening. It involves the addition of education to Social Determinants of Health (SDOH) screening and referral with patient navigation. Patients will be identified, and screened for SDOH needs using the UniteUs SDOH screener that is embedded in the Electronic Health Record (EHR), and connected to geographically-tailored resources (as described above under Arm 1). Participants will then be sent a non-tailored lung screening educational brochure via email to review that details lung cancer risk, lung screening facts, benefits, and potential harms. Within 48 hours, the Community Outreach and Engagement (COE) Patient Navigator will contact the patient to answer questions and provide navigation services as described above in Arm 1.

Primary outcome measure

  • Lung Cancer Screening Uptake [ Time Frame: Assessed at 1 month and 6 months post intervention ]
  • Stage of Adoption for Lung Cancer Screening [ Time Frame: Assessed at 1 week and then at 1 month and 6 months post intervention ]

Central Contacts and Locations

Central contacts

Ana Guadalupe Vielma, PhD

2018803400ana.vielma@hmh-cdi.org

Francis Valenzona

2018803400francis.valenzona@hmh-cdi.org

Locations

Ocean Medical Center

Recruiting

Brick, New Jersey, United States, 08724

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

John F. Kennedy Medical Center

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Bayshore Medical Center

Recruiting

Holmdel, New Jersey, United States, 07733

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Southern Ocean Medical Center

Recruiting

Manahawkin, New Jersey, United States, 08050

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Palisades Medical Center

Recruiting

North Bergen, New Jersey, United States, 07047

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Old Bridge Medical Center

Recruiting

Old Bridge, New Jersey, United States, 08857

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Raritan Bay Medical Center

Recruiting

Perth Amboy, New Jersey, United States, 08861

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

Riverview Medical Center

Recruiting

Red Bank, New Jersey, United States, 07701

Contacts

Gia Nealy

201-880-3564gia.nealy@hmh-cdi.org

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • screening
  • lung cancer
  • Disparities
  • social determinants of health
  • emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-09-08.