RECRUITING

Leveraging the Emergency Department (LEAD) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-29
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06605534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 50 years to 80 years
  2. * Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
  3. * 20 pack-year smoking history
  4. * Has never had lung cancer screening
  5. * Able to provide informed consent
  6. * Able to speak and understand English
  1. * Diagnosed with lung cancer
  2. * Has a history of having a lung cancer screening scan
  3. * Unable to speak and understand English

Contacts and Locations

Study Contact

Ana Guadalupe Vielma, PhD
CONTACT
2018803400
ana.vielma@hmh-cdi.org
Francis Valenzona
CONTACT
2018803400
francis.valenzona@hmh-cdi.org

Principal Investigator

Lisa Carter-Bawa, PhD
PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health

Study Locations (Sites)

Ocean Medical Center
Brick, New Jersey, 08724
United States
John F. Kennedy Medical Center
Edison, New Jersey, 08820
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Bayshore Medical Center
Holmdel, New Jersey, 07733
United States
Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Palisades Medical Center
North Bergen, New Jersey, 07047
United States
Old Bridge Medical Center
Old Bridge, New Jersey, 08857
United States
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States

Collaborators and Investigators

Sponsor: Hackensack Meridian Health

  • Lisa Carter-Bawa, PhD, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2024-10-29
Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Lung Cancer