Health Education Approach to Lung Screening

Virginia Commonwealth University675 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

675

Conditions

Lung Cancer

Interventions

Patient NavigationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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 Outcomes

Assess the feasibility and acceptability of the patient navigation program

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".

Time frame: Day 1

Assess the feasibility and acceptability of the patient navigation program

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.

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.

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.

Time frame: Day 1

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

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.

Central Contacts

Massey IIT Research Operations

CONTACT

804-628-6430 masseyepd@vcu.edu

Data from ClinicalTrials.gov

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