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Trial Title:
Health Education Approach to Lung Screening
NCT ID:
NCT06070870
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
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
Arm group label:
Patient Navigation
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).
Criteria for eligibility:
Criteria:
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 exclusion criteria is ineligible to participate
in the study:
- 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
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of North Carolina-Chapel Hill
Address:
City:
Carrboro
Zip:
27510
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Christopher Lyu, MPA
Phone:
919-966-2865
Email:
Christopher_Lyu@med.unc.edu
Contact backup:
Last name:
Alison Brenner, MD
Phone:
(919) 966-2865
Investigator:
Last name:
Alison Brenner, MD
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ellen Gomez, MA
Phone:
843-876-2428
Email:
gomezel@musc.edu
Contact backup:
Last name:
Marvella Ford, MD
Phone:
843-876-2428
Investigator:
Last name:
Marvella Ford, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Massey CPC Team
Phone:
804-828-1965
Email:
MasseyCPC@vcu.edu
Contact backup:
Last name:
CTO Clinical Operations Managers
Email:
ctoclinops@vcu.edu
Investigator:
Last name:
Vanessa Sheppard, PhD
Email:
Principal Investigator
Start date:
October 10, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Virginia Commonwealth University
Agency class:
Other
Collaborator:
Agency:
Stand Up To Cancer
Agency class:
Other
Source:
Virginia Commonwealth University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06070870
