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Recruiting NCT06070870

Health Education Approach to Lung Screening

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Navigation.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Health Education Approach to Lung Screening (HEALS)

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)

Detailed description

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

Interventions

  • 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

Primary outcome measures

  • Number of study patients who complete lung cancer screening (LCS) through the patient navigation process [Time frame: 2 weeks to 10 months following day 1, varies by participant]
Secondary outcome measures (6)
  • Assess the feasibility and acceptability of the patient navigation program [Time frame: Day 1]
  • Assess the feasibility and acceptability of the patient 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. [Time frame: Day 1]
  • Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention. [Time frame: 2 weeks to 10 months following day 1, varies by participant]
  • Assess the impact of the patient navigation program on patient financial distress [Time frame: Day 1]
  • Assess the impact of the patient navigation program on patient financial distress [Time frame: 2 weeks to 10 months following day 1, varies by participant]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 3 centers
  • University of North Carolina-Chapel Hill — Carrboro
  • Medical University of South Carolina — Charleston
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06070870 · SU2C-WINN · HM20026222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗