Leveraging the Emergency Department (LEAD) Study

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

50 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LungTalk — BEHAVIORAL
  Tailored lung screening intervention
• Non-tailored lung screening — OTHER
  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.

Study Details

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.

Key Dates

Start date

Oct 29, 2024

Status verified

Feb 2026

Primary completion

Oct 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

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.

Primary Outcome Measure

Lung Cancer Screening Uptake [ Time Frame: Assessed at 1 month and 6 months post intervention ]

Central Contacts

• Ana Guadalupe Vielma, PhD
  2018803400
  [email protected]
• Francis Valenzona
  2018803400
  [email protected]

Locations (10)

Find similar trials in Brick, NJ

Related Studies

• Collection of Sputum and Labeling for Lung Cancer
  Recruiting · bioAffinity Technologies Inc. · Summit, New Jersey
• VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
  PHASE1/PHASE2 · Recruiting · VM Oncology, LLC · Santa Rosa, California
• Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
  Recruiting · The Cooper Health System · Camden, New Jersey