Improving access to lung cancer screening through patient navigation
Health Education Approach to Lung Screening (HEALS)
This study tests a patient navigation program to help more people, especially Black or African-American individuals with a certain smoking history, get screened for lung cancer using low dose CT scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 675 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 3 sites (Carrboro, North Carolina and 2 other locations) |
| Trial ID | NCT06070870 on ClinicalTrials.gov |
What this trial studies
This study evaluates a patient navigation program aimed at increasing the number of individuals who complete lung cancer screening using low dose computed tomography (LDCT). It is a single-arm intervention that focuses on guiding eligible patients through the screening process to enhance access and completion rates. The program targets individuals who meet specific smoking history and demographic criteria, particularly those identifying as Black or African-American. The effectiveness of this approach will be assessed by measuring the proportion of patients who undergo the screening after receiving navigation support.
Who should consider this trial
Good fit: Ideal candidates for this study are Black or African-American individuals with a significant smoking history who meet the current guidelines for lung cancer screening.
Not a fit: Patients with a known history of cancer (except for certain skin cancers) or those who have experienced specific health issues in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly increase lung cancer screening rates among high-risk populations, leading to earlier detection and improved outcomes.
How similar studies have performed: Other studies have shown that patient navigation can effectively improve screening rates in various populations, suggesting a promising approach for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Carrboro, North Carolina and 2 other locations
- University of North Carolina-Chapel Hill — Carrboro, North Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Vanessa Sheppard, PhD — Virginia Commonwealth University
- Study coordinator: Massey IIT Research Operations
- Email: masseyepd@vcu.edu
- Phone: 804-628-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.