Health Education Approach to Lung Screening

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Patient Navigation

• 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

Arm && Interventions

Group	Intervention	Description
Patient Navigation	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

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