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| ID | Type | Description | Link |
|---|---|---|---|
| HM20026222 | Other Identifier | Virginia Commonwealth University |
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| Name | Class |
|---|---|
| Stand Up To Cancer | OTHER |
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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)
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigation | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | Navigation will address the following 4 domains of barriers to screening:
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 weeks to 10 months following day 1, varies by participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Day 1 |
| Assess the feasibility and acceptability of the patient navigation program |
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Inclusion Criteria:
One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massey IIT Research Operations | Contact | 804-628-6430 | masseyepd@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Sheppard, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina-Chapel Hill | Recruiting | Carrboro | North Carolina | 27510 | United States |
Currently there is not a plan to share with other researchers not working on the protocol.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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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. |
| 2 weeks to 10 months following day 1, varies by participant |
| 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. | Day 1 |
| 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. | 2 weeks to 10 months following day 1, varies by participant |
| Assess the impact of the patient navigation program on patient financial distress | 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. | Day 1 |
| Assess the impact of the patient navigation program on patient financial distress | 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. | 2 weeks to 10 months following day 1, varies by participant |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006298 | Health Services Administration |