Awareness, Information, and Resources for Lung Cancer Screening Program for Community-Partnered Lung Cancer Screening
Primary Purpose
Lung Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Questionnaire Administration
Sponsored by
About this trial
This is an interventional prevention trial for Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Members of all races and ethnic groups are eligible for this study
Exclusion Criteria:
- Adults unable to consent
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prevention (AIR Program)
Arm Description
Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet..
Outcomes
Primary Outcome Measures
Number of programs offered
Average number of attendees at each site
Demographics of attendees at each site
Number of medically underserved, high risk community members reached
Percent change in lung cancer screening awareness as assessed before and after program completion
Pre and post questionnaire to be given to participants
Percent change in knowledge of eligibility guidelines for screening as assessed before and after program completion
Pre and post questionnaire to be given to participants before and after educational sessions
Percent Change in knowledge of benefits of early detection as assessed before and after program completion
Pre and post questionnaire to be completed by participants before and after educational sessions
Change in fear, worry, and increased health-related self-efficacy
Pre and post questionnaire to be completed by participants before and after educational sessions
Number of screening eligible individuals reached
Number of screening eligible individuals navigated to lung cancer screening
Secondary Outcome Measures
Full Information
NCT ID
NCT04635761
First Posted
November 5, 2020
Last Updated
September 27, 2022
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04635761
Brief Title
Awareness, Information, and Resources for Lung Cancer Screening Program for Community-Partnered Lung Cancer Screening
Official Title
The Roswell AIR (Awareness, Information and Resources for Lung Cancer Screening) Program: A Community-Partnered Lung Cancer Screening Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
August 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial investigates an educational program called Awareness, Information, and Resources for Lung Cancer Screening Program in improving knowledge about lung cancer screening in medically underserved communities. This program aims to educate and remove barriers to lung cancer screening among medically underserved community members who are eligible for lung cancer screening, and to improve access to evidence-based screening guidelines for early detection for lung cancer in the Western New York area.
Detailed Description
PRIMARY OBJECTIVES:
I. Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about lung cancer screening.
II. Reach medically underserved, high risk community members. III. Enhance lung cancer screening knowledge among medically underserved, high risk community members.
IV. Navigate screening-eligible community members to lung cancer screening.
OUTLINE:
Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
292 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevention (AIR Program)
Arm Type
Experimental
Arm Description
Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet..
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Complete AIR Program and receive the High-Risk Lung Cancer Tip Sheet
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Number of programs offered
Time Frame
Up to 1 year
Title
Average number of attendees at each site
Time Frame
Up to 1 year
Title
Demographics of attendees at each site
Time Frame
Up to 1 year
Title
Number of medically underserved, high risk community members reached
Time Frame
Up to 1 year
Title
Percent change in lung cancer screening awareness as assessed before and after program completion
Description
Pre and post questionnaire to be given to participants
Time Frame
Up to 1 year
Title
Percent change in knowledge of eligibility guidelines for screening as assessed before and after program completion
Description
Pre and post questionnaire to be given to participants before and after educational sessions
Time Frame
Up to 1 year
Title
Percent Change in knowledge of benefits of early detection as assessed before and after program completion
Description
Pre and post questionnaire to be completed by participants before and after educational sessions
Time Frame
Up to 1 year
Title
Change in fear, worry, and increased health-related self-efficacy
Description
Pre and post questionnaire to be completed by participants before and after educational sessions
Time Frame
Up to 1 year
Title
Number of screening eligible individuals reached
Time Frame
Up to 1 year
Title
Number of screening eligible individuals navigated to lung cancer screening
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Members of all races and ethnic groups are eligible for this study
Exclusion Criteria:
Adults unable to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bouchard
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Awareness, Information, and Resources for Lung Cancer Screening Program for Community-Partnered Lung Cancer Screening
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