Lung Cancer ScreeningNCT05920850
The SHARED, Project, Lung Cancer Screening for African American Men (AAM)
A study testing Educational Video about LDCT lung cancer screening, A culturally tailored shared decision-making tool and Flip chart in people with Lung Cancer Screening, run by University of Illinois Chicago at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Educational Video about LDCT lung cancer screening, A culturally tailored shared decision-making tool and Flip chart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not self-identify as African American males
- Former smokers
- Self-report a history of lung cancer symptoms
- Do not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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
- Conditions
- Lung Cancer Screening
- Being tested
- Educational Video about LDCT lung cancer screening, A culturally tailored shared decision-making tool, Flip chart, Navigation support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video about LDCT lung cancer screeningOther
A culturally tailored video that provides education about the process LDCT lung cancer screening
A culturally tailored shared decision-making toolOther
A culturally tailored shared decision-making tool that educates participants about the shared decision-making process
Flip chartOther
The use of a flip chart that reinforces the information provided in the video and shared decision-making tool
Navigation supportOther
Navigation support for participants who express interest in LDCT and quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Educational Video about LDCT lung cancer screening; Other: A culturally tailored shared decision-making tool; Other: Flip chart; Other: Navigation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Assess completion of referral to smoking cessation treatment
Number of participants that completed the referral to smoking cessation treatment to the ITQL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start14 Jul 2023
- Primary completion27 Oct 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohan Dexter Jeremiah, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920850
- Sponsor's protocol ID
- 2023-0273
- Status last verified
- May 2024
- First submitted
- 17 Jun 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SHARED Project (Testing a Lung Cancer Screening Intervention for AAM)
- ClinicalTrials.gov ID
- NCT05920850
- Acronym / sponsor ID
- 2023-0273
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: Educational Video about LDCT lung cancer screening, Other: A culturally tailored shared decision-making tool, Other: Flip chart, Other: Navigation support1. 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Do not self-identify as African American males
- Former smokers
- Self-report a history of lung cancer symptoms
- Do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Video about LDCT lung cancer screeningA culturally tailored video that provides education about the process LDCT lung cancer screening | Other | Single Arm |
| A culturally tailored shared decision-making toolA culturally tailored shared decision-making tool that educates participants about the shared decision-making process | Other | Single Arm |
| Flip chartThe use of a flip chart that reinforces the information provided in the video and shared decision-making tool | Other | Single Arm |
| Navigation supportNavigation support for participants who express interest in LDCT and quitting smoking. | Other | Single Arm |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video about LDCT lung cancer screening, A culturally tailored shared decision-making tool and Flip chart in people with Lung Cancer Screening, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.