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

Study Overview
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Brief Summary
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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
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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

Official Title
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The SHARED Project (Testing a Lung Cancer Screening Intervention for AAM)

Conditions
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Lung Cancer Screening

Intervention / Treatment
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* Other: Educational Video about LDCT lung cancer screening
* Other: A culturally tailored shared decision-making tool
* Other: Flip chart
* Other: Navigation support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>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 | Other: Educational Video about LDCT lung cancer screening<br>* A culturally tailored video that provides education about the process LDCT lung cancer screening<br>Other: A culturally tailored shared decision-making tool<br>* A culturally tailored shared decision-making tool that educates participants about the shared decision-making process<br>Other: Flip chart<br>* The use of a flip chart that reinforces the information provided in the video and shared decision-making tool<br>Other: Navigation support<br>* Navigation support for participants who express interest in LDCT and quitting smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| Assess the completion of a healthcare visit for the purpose of lung cancer screening ces | Number of participants that complete lung cancer screeninf | 1 year | 
| Assess completion of referral to smoking cessation treatment | Number of participants that completed the referral to smoking cessation treatment to the ITQL | 1 year |