Clinical trial NCT06070870: Health Education Approach to Lung Screening
Official title: Health Education Approach to Lung Screening (HEALS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Screening
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Stand Up To Cancer
First posted: 2023-10-06
Enrollment: 225
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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)

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

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

Primary outcomes:
measure: Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
timeFrame: 2 weeks to 4 months following day 1, varies by participant
Secondary outcomes:
measure: Assess the feasibility and acceptability of the patient navigation program
timeFrame: Day 1
measure: Assess the feasibility and acceptability of the patient navigation program
timeFrame: 2 weeks to 4 months following day 1, varies by participant
measure: Assess the impact of the patient navigation program on patient health-related quality of life at baseline.
timeFrame: Day 1
measure: Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.
timeFrame: 2 weeks to 4 months following day 1, varies by participant
measure: Assess the impact of the patient navigation program on patient financial distress
timeFrame: Day 1
measure: Assess the impact of the patient navigation program on patient financial distress
timeFrame: 2 weeks to 4 months following day 1, varies by participant
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Vanessa Sheppard, PhD
role: PRINCIPAL_INVESTIGATOR
References: