Health Education Approach to Lung Screening

Lung Cancer Clinical Trial

— HEALS  

Official title:

Health Education Approach to Lung Screening (HEALS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070870
• Other study ID #: SU2C-WINN
• Secondary ID: HM20026222
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: Kendra Rowe
• Phone: 804-628-6430
• Email: MasseyCPC[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: April 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Patient Navigation
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

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Stand Up To Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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