Recruiting

Health Education

Sponsor:

Virginia Commonwealth University

Code:

NCT06070870

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Patient Navigation

Study Details

Brief 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)

Conditions

Lung Cancer

Study ID

NCT06070870

Start date

Oct 10, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

675 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Patient Navigation

Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant

Interventions

Patient 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

Primary outcome measure

  • Number of study patients who complete lung cancer screening (LCS) through the patient navigation process [ Time Frame: 2 weeks to 10 months following day 1, varies by participant ]

Central Contacts and Locations

Central contacts

Massey IIT Research Operations

804-628-6430masseyepd@vcu.edu

Locations

University of North Carolina-Chapel Hill

Recruiting

Carrboro, North Carolina, United States, 27510

Contacts

Christopher Lyu, MPA

(919) 966-2865Christopher_Lyu@med.unc.edu

Alison Brenner, MD

(919) 966-2865

Principal Investigator:

Alison Brenner, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Megan Ellison, Ed.D

843-876-2428ellisome@musc.edu

Marvella Ford, MD

843-876-2428

Principal Investigator:

Marvella Ford, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Massey CPC Team

804-628-6430MasseyCPC@vcu.edu

Principal Investigator:

Sun Jung Kim, PhD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Lung cancer
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-25.