Health Education Approach to Lung Screening (HEALS)

Health Education Approach to Lung Screening (HEALS)

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)

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Patient Navigation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 675
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massey IIT Research Operations; Phone Number: 804-628-6430; Email: masseyepd@vcu.edu

Study Locations

• United States
  • North Carolina
    • Carrboro, North Carolina, United States, 27510
      • Recruiting
      • University of North Carolina-Chapel Hill
      • Contact: Alison Brenner, MD; Phone Number: (919) 966-2865
      • Principal Investigator: Alison Brenner, MD
      • Contact: Christopher Lyu, MPA; Phone Number: (919) 966-2865; Email: Christopher_Lyu@med.unc.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Marvella Ford, MD; Phone Number: 843-876-2428
      • Principal Investigator: Marvella Ford, MD
      • Contact: Megan Ellison, Ed.D; Phone Number: 843-876-2428; Email: ellisome@musc.edu
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Principal Investigator: Vanessa Sheppard, PhD
      • Contact: Massey CPC Team; Phone Number: 804-628-6430; Email: MasseyCPC@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

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 10 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 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 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 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 10 months following day 1, varies by participant
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 10 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 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 10 months following day 1, varies by participant

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Stand Up To Cancer
• Investigators: Principal Investigator: Vanessa Sheppard, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lung cancer; Screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: SU2C-WINN; HM20026222 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently there is not a plan to share with other researchers not working on the protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No