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Recruiting NCT06605534

Leveraging the Emergency Department (LEAD) Study

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LungTalk, Non-tailored lung screening.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities

Overview

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.

Interventions

  • Behavioral LungTalk
    Tailored lung screening intervention
  • Other 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

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Health Literacy Scale [Time frame: At one week and one month post intervention]
  • Medical Mistrust Scale [Time frame: At one week and one month post intervention]
  • Perceived Stigma Scale [Time frame: At one week and one month post intervention]
  • Perceived Risk of Lung Cancer Scale [Time frame: At one week and one month post intervention]
  • Perceived Benefits of Lung Cancer Screening Scale [Time frame: At one week and one month post intervention]
  • Perceived Barriers to Lung Cancer Screening Scale [Time frame: At one week and one month post intervention]
  • Self-Efficacy for Lung Cancer Screening Scale [Time frame: At one week and one month post intervention]
  • Knowledge: Lung Cancer and Screening Scale [Time frame: At one week and one month post intervention]
  • Lung Cancer Fatalism [Time frame: At one week and one month post intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 10 centers
  • Ocean Medical Center — Brick
  • John F. Kennedy Medical Center — Edison
  • Hackensack University Medical Center — Hackensack
  • Bayshore Medical Center — Holmdel
  • Southern Ocean Medical Center — Manahawkin
  • Jersey Shore University Medical Center — Neptune City
  • Palisades Medical Center — North Bergen
  • Old Bridge Medical Center — Old Bridge
  • … and 2 more centers

Publications

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available. PMID 33532112
  • Cancer Facts & Figures for African Americans 2019-2021. In: American Cancer Society. Atlanta: 2019.
  • United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening.http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatem entFinal/lung-cancer-screening. Updated December 2016. Accessed January 21, 2023.
  • Rivera MP, Katki HA, Tanner NT, Triplette M, Sakoda LC, Wiener RS, Cardarelli R, Carter-Harris L, Crothers K, Fathi JT, Ford ME, Smith R, Winn RA, Wisnivesky JP, Henderson LM, Aldrich MC. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020 Oct 1;202(7):e95-e112. doi: 10.1164/rccm.202008- PMID 33000953
  • Carter-Harris L, Tan AS, Salloum RG, Young-Wolff KC. Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS). Patient Educ Couns. 2016 Nov;99(11):1772-1777. doi: 10.1016/j.pec.2016.05.014. Epub 2016 May 17. PMID 27241830
  • American Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019.
  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
  • United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening (updated). https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Updated March 9, 2021. Accessed February 21, 2024.

Identifiers

NCT: NCT06605534 · Pro2024-0236

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗