search
Back to results

The SHARED, Project, Lung Cancer Screening for African American Men (AAM)

Primary Purpose

Lung Cancer Screening

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video about LDCT lung cancer screening
A culturally tailored shared decision-making tool
Flip chart
Navigation support
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer Screening

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Self-identify as African American or Black males Current smokers of any nicotine-containing products Do not self-report a history of lung cancer symptoms Speaks English Exclusion Criteria: Do not self-identify as African American males Former smokers Self-report a history of lung cancer symptoms Do not speak English

Sites / Locations

  • University of IllinoisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

A culturally tailored video that provides education about the process of low-dose helical computed tomography (LDCT) lung cancer screening A culturally tailored shared decision-making tool that educates participants about the shared decision-making process The use of a flip chart that reinforces the information provided in the video and shared decision-making tool Navigation support for participants who express interest in LDCT and quitting smoking

Outcomes

Primary Outcome Measures

Assess changes in knowledge, attitudes, risk perception, and intention/ stage of readiness to engage in lung cancer screening and smoking cessation
Number of participants that show an improvement from pretest to poattest
Assess the completion of a healthcare visit for the purpose of lung cancer screening ces
Number of participants that complete lung cancer screeninf
Assess completion of referral to smoking cessation treatment
Number of participants that completed the referral to smoking cessation treatment to the ITQL

Secondary Outcome Measures

Full Information

First Posted
June 17, 2023
Last Updated
October 18, 2023
Sponsor
University of Illinois at Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT05920850
Brief Title
The SHARED, Project, Lung Cancer Screening for African American Men (AAM)
Official Title
The SHARED Project (Testing a Lung Cancer Screening Intervention for AAM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a single-arm pre-test post-test design with a two-month follow-up assessment. The study aims to provide support to participants in quitting smoking and accessing lung cancer screening through the combination of education interventions and patient navigation (PN)
Detailed Description
This study is a single-arm pre-test post-test design with a two-month follow-up assessment. The study aims to provide support to participants in quitting smoking and accessing lung cancer screening through the combination of education interventions and patient navigation (PN). After participant consent the study team will administer a series of surveys to collect the participant's contact information and complete the study's pretest measures. These include a demographic survey, smoking history, lung cancer knowledge, lung screening knowledge, intention to quit/screen, informed to decide, satisfaction survey, and decision conflict survey. The study also consists of three scheduled meetings with the PN lasting up to 60 minutes. The 1st session will be held between 7-14 days after consent. The 2nd session will be held 7-14 after the 1st session and the 3rd session will be held 42-49 days after the 1st session. Additional phone calls will last 10 minutes or less and be focused on specific questions generated by study participants. In the 1st session the PN will re-orient participant to the goals and objectives of the project and answer participant questions before starting the intervention. The 1st activity will be to show a 3 minute culturally tailored video that will explain the benefits of lung cancer screening for African American Males (AAM) using an internet-enabled device. After completion of the video, the PN will invite the participant to ask any questions that they have and the PN will offer clarifying information. The PN will review with the participant a culturally adapted shared decision-making tool. The participant will complete the posttest surveys as described abov. In the 2nd session the PN will determine the scheduling and completion of lung cancer screening and Illinois Tobacco Quit Line (ITQL) engagement. The participant will complete the LDCT screening, navigation needs, Quitline Engagement, and decision change surveys In the 3rd session the PN will determine scheduling, barriers and completion of lung cancer screening and Quitline engagement. The participant will complete LDCT screening check, and a Quitline engagement check

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
A culturally tailored video that provides education about the process of low-dose helical computed tomography (LDCT) lung cancer screening A culturally tailored shared decision-making tool that educates participants about the shared decision-making process The use of a flip chart that reinforces the information provided in the video and shared decision-making tool Navigation support for participants who express interest in LDCT and quitting smoking
Intervention Type
Other
Intervention Name(s)
Educational Video about LDCT lung cancer screening
Intervention Description
A culturally tailored video that provides education about the process LDCT lung cancer screening
Intervention Type
Other
Intervention Name(s)
A culturally tailored shared decision-making tool
Intervention Description
A culturally tailored shared decision-making tool that educates participants about the shared decision-making process
Intervention Type
Other
Intervention Name(s)
Flip chart
Intervention Description
The use of a flip chart that reinforces the information provided in the video and shared decision-making tool
Intervention Type
Other
Intervention Name(s)
Navigation support
Intervention Description
Navigation support for participants who express interest in LDCT and quitting smoking.
Primary Outcome Measure Information:
Title
Assess changes in knowledge, attitudes, risk perception, and intention/ stage of readiness to engage in lung cancer screening and smoking cessation
Description
Number of participants that show an improvement from pretest to poattest
Time Frame
1 year
Title
Assess the completion of a healthcare visit for the purpose of lung cancer screening ces
Description
Number of participants that complete lung cancer screeninf
Time Frame
1 year
Title
Assess completion of referral to smoking cessation treatment
Description
Number of participants that completed the referral to smoking cessation treatment to the ITQL
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-identify as African American or Black males Current smokers of any nicotine-containing products Do not self-report a history of lung cancer symptoms Speaks English Exclusion Criteria: Do not self-identify as African American males Former smokers Self-report a history of lung cancer symptoms Do not speak English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremaih Rohan, PhD
Phone
312-996-8945
Email
rjerem@uic.edu
Facility Information:
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremaih R Rohan
Phone
312-996-8945
Email
rjerem@uic.edu

12. IPD Sharing Statement

Learn more about this trial

The SHARED, Project, Lung Cancer Screening for African American Men (AAM)

We'll reach out to this number within 24 hrs