Back to resultsHealth Education Approach to Lung Screening (HEALS)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Lung cancer, Screening
Eligibility Criteria
Inclusion Criteria: Meets current USPSTF guidelines for lunc 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), chronic obstructive pulmonary disease (COPD), emphysema, or coughing up blood in the past 5 years, as reported by the individual 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
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient Navigation
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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".
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT06070870
First Posted
September 30, 2023
Last Updated
October 13, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Stand Up To Cancer
1. Study Identification
Unique Protocol Identification Number
NCT06070870
Brief Title
Health Education Approach to Lung Screening
Acronym
HEALS
Official Title
Health Education Approach to Lung Screening (HEALS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Stand Up To Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
Detailed Description
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Navigation
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention 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
Primary Outcome Measure Information:
Title
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
Description
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 4 months following day 1, varies by participant
Secondary Outcome Measure Information:
Title
Assess the feasibility and acceptability of the patient navigation program
Description
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 1
Title
Assess the feasibility and acceptability of the patient navigation program
Description
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 4 months following day 1, varies by participant
Title
Assess the impact of the patient navigation program on patient health-related quality of life at baseline.
Description
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 1
Title
Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.
Description
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 4 months following day 1, varies by participant
Title
Assess the impact of the patient navigation program on patient financial distress
Description
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.
Time Frame
Day 1
Title
Assess the impact of the patient navigation program on patient financial distress
Description
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.
Time Frame
2 weeks to 4 months following day 1, varies by participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Meets current USPSTF guidelines for lunc 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), chronic obstructive pulmonary disease (COPD), emphysema, or coughing up blood in the past 5 years, as reported by the individual
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Rowe
Phone
804-628-6430
Email
MasseyCPC@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Massey CPC Team
Email
MasseyCPC@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Sheppard, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massey CPC Team
Phone
804-828-1965
Email
MasseyCPC@vcu.edu
First Name & Middle Initial & Last Name & Degree
CTO Clinical Operations Managers
Email
ctoclinops@vcu.edu
First Name & Middle Initial & Last Name & Degree
Vanessa Sheppard, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is not a plan to share with other researchers not working on the protocol.
Learn more about this trial
Health Education Approach to Lung Screening
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