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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05920850
Collaborator
(none)
40
1
36

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Video about LDCT lung cancer screening
  • Other: A culturally tailored shared decision-making tool
  • Other: Flip chart
  • Other: Navigation support
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The SHARED Project (Testing a Lung Cancer Screening Intervention for AAM)
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Single Arm

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
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.

Outcome Measures

Primary Outcome Measures

  1. Assess changes in knowledge, attitudes, risk perception, and intention/ stage of readiness to engage in lung cancer screening and smoking cessation [1 year]

    Number of participants that show an improvement from pretest to poattest

  2. Assess the completion of a healthcare visit for the purpose of lung cancer screening ces [1 year]

    Number of participants that complete lung cancer screeninf

  3. Assess completion of referral to smoking cessation treatment [1 year]

    Number of participants that completed the referral to smoking cessation treatment to the ITQL

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rohan Dexter Jeremiah, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT05920850
Other Study ID Numbers:
  • 2023-0273
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2023