Health Education Approach to Lung Screening

Study Overview
=================
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).

Official Title
-----------------
Health Education Approach to Lung Screening (HEALS)

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Patient Navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets current USPSTF guidelines for lunc 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), chronic obstructive pulmonary disease (COPD), emphysema, or coughing up blood in the past 5 years, as reported by the individual 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigation<br>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 | Behavioral: Patient Navigation<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 weeks to 4 months following day 1, varies by participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 weeks to 4 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. | 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. | 2 weeks to 4 months following day 1, varies by participant | 
| Assess the impact of the patient navigation program on patient financial distress | Determine the number of participants that have financial distress at baseline utilizing Financial Distress measure scores at baseline. Study-specific financial distress measure (8 items) each item will need to be individually coded 1-5, with 1=completely disagree to 5=completely agree and 98 for Don't know and 99 for Not applicable. | Day 1 | 
| Assess the impact of the patient navigation program on patient financial distress | 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. | 2 weeks to 4 months following day 1, varies by participant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Screening