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

May 30, 2024 updated by: Rohan Dexter Jeremiah, University of Illinois at Chicago

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Self-identify as African American or Black males
  2. Current smokers of any nicotine-containing products
  3. Do not self-report a history of lung cancer symptoms
  4. Speaks English

Exclusion Criteria:

  1. Do not self-identify as African American males
  2. Former smokers
  3. Self-report a history of lung cancer symptoms
  4. Do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
  1. A culturally tailored video that provides education about the process of low-dose helical computed tomography (LDCT) lung cancer screening
  2. A culturally tailored shared decision-making tool that educates participants about the shared decision-making process
  3. The use of a flip chart that reinforces the information provided in the video and shared decision-making tool
  4. Navigation support for participants who express interest in LDCT and quitting smoking
Other: Educational Video about LDCT lung cancer screening
A culturally tailored video that provides education about the process LDCT lung cancer screening
Other: A culturally tailored shared decision-making tool
A culturally tailored shared decision-making tool that educates participants about the shared decision-making process
Other: Flip chart
The use of a flip chart that reinforces the information provided in the video and shared decision-making tool
Other: Navigation support
Navigation support for participants who express interest in LDCT and quitting smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess completion of referral to smoking cessation treatment
Time Frame: 1 year
Number of participants that completed the referral to smoking cessation treatment to the ITQL
1 year
Assess changes in knowledge, attitudes, risk perception, and intention/ stage of readiness to engage in lung cancer screening and smoking cessation
Time Frame: 1 year
Number of participants that show an improvement from pretest to posttest
1 year
Assess the completion of a healthcare visit for the purpose of lung cancer screening ces
Time Frame: 1 year
Number of participants that complete lung cancer screening
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

June 17, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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