Health Education Approach to Lung Screening
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorVirginia Commonwealth University
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Patient Navigation
BehavioralNavigation 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
Treatment groups
675 Participants
are divided into 1 treatment groupGroup A: Patient NavigationExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
2 weeks to 10 months following day 1, varies by participantSecondary outcomes
1
Assess the feasibility and acceptability of the patient navigation program
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".
Time frame
Day 12
Assess the feasibility and acceptability of the patient navigation program
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.
Time frame
2 weeks to 10 months following day 1, varies by participant3
Assess the impact of the patient navigation program on patient health-related quality of life at baseline.
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.
Time frame
Day 14
Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.
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.
Time frame
2 weeks to 10 months following day 1, varies by participantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
Stand Up To Cancer
Collaborator
Source ClinicalTrials.gov