Lung Cancer
Conditions
Keywords
Lung cancer, 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).
Interventions
BEHAVIORALPatient 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
Sponsors
Virginia Commonwealth University
Stand Up To Cancer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of study patients who complete lung cancer screening (LCS) through the patient navigation process | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess the feasibility and acceptability of the patient navigation program | 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". |
| Assess the impact of the patient navigation program on patient health-related quality of life at baseline. | 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. |
| Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention. | 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. |
| Assess the impact of the patient navigation program on patient financial distress | 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. |
Countries
United States
Contacts
CONTACTMassey IIT Research Operations
PRINCIPAL_INVESTIGATORSun Jung Kim, PhD
Virginia Commonwealth University
Outcome results
None listed