Health Education Approach to Lung Screening

Not Applicable

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06070870
• Lead Sponsor: Virginia Commonwealth University

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)

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-09-30
• Study First Submitted QC: 2023-09-30
• Study First Posted: 2023-10-06
• Study Start: 2023-10-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-03-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process	2 weeks to 4 months following day 1, varies by participant	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).

Secondary Outcome Measures

Name	Time	Method
Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.	2 weeks to 4 months following day 1, varies by participant	Utilizing Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items) scores before and after navigation intervention. Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items), measures assess physical, mental, and social health, where 5=Never, 4=Rarely, 3=Sometimes, 2=Often, and 1=Always. Higher scores indicate better health.
Assess the feasibility and acceptability of the patient navigation program	2 weeks to 4 months following day 1, varies by participant	Determine the number of participants that are satisfied with the navigation program by utilizing Was It Worth It instrument; that consists of 8 items that are are answered "yes", "no" or "uncertain" after the navigation program.
Assess the impact of the patient navigation program on patient health-related quality of life at baseline.	Day 1	Utilizing Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items) scores before and after navigation intervention. Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items), measures assess physical, mental, and social health where 5=Never, 4=Rarely, 3=Sometimes, 2=Often, and 1=Always. Higher scores indicate better health.
Assess the impact of the patient navigation program on patient financial distress	2 weeks to 4 months following day 1, varies by participant	Determine the number of participants that have lessening financial distress after the navigation program utilizing Financial Distress measure scores at baseline. Study-specific financial distress measure (8 items) each item will be individually coded 1-5, with 1=completely disagree to 5=completely agree and 98 for Don't know and 99 for Not applicable.

Trial Locations

Locations (3)

University of North Carolina-Chapel Hill; 🇺🇸 Carrboro, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States