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A Patient Navigation Program for Increasing Lung Cancer Screening in Older Adult Black or African American Smokers, HEALS Trial
Trial Status: active
This clinical trial evaluates a patient navigation program for increasing uptake of lung cancer screening among older adult Black or African American smokers. Patient navigators are trained professionals who help people through a specific healthcare process, such as lung cancer screening. In this study, the patient navigator assesses a participant's barriers to lung cancer screening across multiple areas (individual, organization, economic, and sociocultural) and then provides resources for overcoming these barriers. Patient navigation services may increase the number of smokers who decide to undergo lung cancer screening.
Inclusion Criteria
Meets current United States Preventive Services Task Force (USPSTF) guidelines for LCS
* Adults aged 50 to 80 years
* 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
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06070870.
I. Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing an low dose computed tomography (LDCT).
SECONDARY OBJECTIVES:
I. Assess the feasibility and acceptability of the patient navigation program.
II. Assess the impact of the patient navigation program on patient health-related quality of life.
III. Assess the impact of the patient navigation program on patient financial distress.
OUTLINE:
Patients receive navigation services that address the four domains of barriers to screening (individual, organizational, economic, and sociocultural) and are re-contacted by the navigator every 2 to 4 weeks over 2 weeks up to 4 months on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationVCU Massey Comprehensive Cancer Center
