NCT05920850

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

June 17, 2023

Last Update Submit

May 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 posttest

    1 year

  • Assess the completion of a healthcare visit for the purpose of lung cancer screening ces

    Number of participants that complete lung cancer screening

    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

Study Arms (1)

Single Arm

OTHER

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 screeningOther: A culturally tailored shared decision-making toolOther: Flip chartOther: Navigation support

Interventions

A culturally tailored video that provides education about the process LDCT lung cancer screening

Single Arm

A culturally tailored shared decision-making tool that educates participants about the shared decision-making process

Single Arm

The use of a flip chart that reinforces the information provided in the video and shared decision-making tool

Single Arm

Navigation support for participants who express interest in LDCT and quitting smoking.

Single Arm

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Do not self-identify as African American males
  • Former smokers
  • Self-report a history of lung cancer symptoms
  • Do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2023

First Posted

June 27, 2023

Study Start

July 14, 2023

Primary Completion

October 27, 2023

Study Completion

January 31, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations