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NCT Number: NCT06070870

Health Education Approach to Lung Screening

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)

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina-Chapel Hill, Carrboro, North Carolina, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. Assess the feasibility and acceptability of the patient navigation program

    Time frame: Day 1

    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".

  2. Assess the feasibility and acceptability of the patient navigation program

    Time frame: 2 weeks to 10 months following day 1, varies by participant

    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.

  3. Assess the impact of the patient navigation program on patient health-related quality of life at baseline.

    Time frame: Day 1

    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.

  4. 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

    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.

  5. Assess the impact of the patient navigation program on patient financial distress

    Time frame: Day 1

    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.

  6. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Massey IIT Research Operations

CONTACT

[email protected]

804-628-6430

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Stand Up To Cancer

Registry information

Official study title

Health Education Approach to Lung Screening (HEALS)

Acronym: HEALS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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