Health Education Approach to Lung Screening

NCT06070870 | Recruiting DMC

• 2 other identifiers: SU2C-WINNHM20026222
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 3

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)

Conditions

Lung Cancer

Keywords

Lung cancer; Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assess the feasibility and acceptability of the patient navigation program

  Day 1

• Assess the feasibility and acceptability of the patient 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.

  Day 1

• 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

• Assess the impact of the patient navigation program on patient financial distress

  Day 1

Study Arms (1)

Patient Navigation

EXPERIMENTAL

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

Interventions

Patient Navigation BEHAVIORAL

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

Patient Navigation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets current USPSTF guidelines for lung cancer screening (LCS)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stand Up To Cancer: collaborator
• Virginia Commonwealth University: lead

Study Sites (3)

University of North Carolina-Chapel Hill

Carrboro, North Carolina, 27510, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Vanessa Sheppard, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)