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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

About this trial

This is an interventional prevention trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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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