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RecruitingInterventional

Health Education Approach to Lung Screening (HEALS)

NCT ID: NCT06070870Sponsor: Virginia Commonwealth UniversityLast updated: 2026-06-01

Summary

Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

Detailed description

This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).

Arms & interventions

  • BehavioralPatient Navigation

    Navigation will address the following 4 domains of barriers to screening: * Individual * Organizational * Economic * Sociocultural At the first visit, navigators will assess the participant's barriers in each of these domains. Any follow-up visits, if necessary, will be used to help the participant overcome these barriers to screening

Outcome measures

Primary

  • Number of study patients who complete lung cancer screening (LCS) through the patient navigation process

    Evaluate the impact of the patient navigation program on the number of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT).

    Time frame: 2 weeks to 10 months following day 1, varies by participant

Secondary

  • Assess the feasibility and acceptability of the patient navigation program

    Time frame: Day 1

  • Assess the feasibility and acceptability of the patient navigation program

    Time frame: 2 weeks to 10 months following day 1, varies by participant

  • Assess the impact of the patient navigation program on patient health-related quality of life at baseline.

    Time frame: Day 1

  • Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.

    Time frame: 2 weeks to 10 months following day 1, varies by participant

  • Assess the impact of the patient navigation program on patient financial distress

    Time frame: Day 1

  • Assess the impact of the patient navigation program on patient financial distress

    Time frame: 2 weeks to 10 months following day 1, varies by participant

Eligibility criteria

Sex: AllAge: 50 Years to 80 YearsHealthy volunteers: Yes
Inclusion Criteria: * Meets current USPSTF guidelines for lung cancer screening (LCS) * 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime. One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year. * Currently smokes or has quit smoking within the past 15 years * Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino). * Willing to complete all navigation-related study activities * Able to understand and the willingness to sign a written informed consent document Exclusion Criteria: A patient who meets any of the following exclusion criteria is ineligible to participate in the study: * Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual * Has undergone a previous lung cancer screening * Inability to speak English * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Study locations (3)

University of North Carolina-Chapel Hill

Carrboro, North Carolina, 27510

Recruiting
Christopher Lyu, MPA · Contact
Alison Brenner, MD · Contact
Alison Brenner, MD · Principal Investigator

Medical University of South Carolina

Charleston, South Carolina, 29425

Recruiting
Megan Ellison, Ed.D · Contact
Marvella Ford, MD · Contact
Marvella Ford, MD · Principal Investigator

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting
Massey CPC Team · Contact
Vanessa Sheppard, PhD · Principal Investigator