HEALS: Health Education Approach to Lung Screening
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patient Navigation Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant |
Behavioral: Patient 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
|
Outcome Measures
Primary Outcome Measures
- Number of study patients who complete lung cancer screening (LCS) through the patient navigation process [2 weeks to 4 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 Outcome Measures
- 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 feasibility and acceptability of the patient navigation program [2 weeks to 4 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.
- 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 4 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.
- Assess the impact of the patient navigation program on patient financial distress [2 weeks to 4 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Meets current USPSTF guidelines for lunc cancer screening (LCS)
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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.
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Currently smokes or has quit smoking within the past 15 years
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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).
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Willing to complete all navigation-related study activities
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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:
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Known history of cancer (except squamous cell skin cancer), chronic obstructive pulmonary disease (COPD), emphysema, or coughing up blood in the past 5 years, as reported by the individual
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Inability to speak English
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- Stand Up To Cancer
Investigators
- Principal Investigator: Vanessa Sheppard, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SU2C-WINN
- HM20026222