Lung Cancer ScreeningEarly Phase 1NCT02914899
Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
A Early Phase 1 study testing Surveys, Navigation and Focus groups in people with Lung Cancer Screening and Current or Past Cigarette Smoker, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test if our Community Health Worker program can help at-risk NYC Chinese community members participate in shared decision making and lung cancer screening (if appropriate) and compare it to the help provided by written materials. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lung Cancer Screening, Current or Past Cigarette Smoker
- What is being tested?
- Surveys, Navigation and Focus groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 19 Nov 2025
- Phase
- Early Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Focus Group Participants:
- Of Chinese descent
- Non-U.S. born
- Fluent in Mandarin
- Livery driver
- Age 45-80
Show all 39Show fewer
- Current or past (within 15 years) cigarette smoker (no specific pack year requirement)
- In Depth Interview Participants Livery Staff
- Of Chinese descent
- Non-U.S. born
- Fluent in Mandarin
- Livery base owner or employee
- Age ≥ 21
- Health Care Providers and Administrators:
- Primary care physician, clinic director, hospital administrator, or radiology facility or department administrator
- Age ≥ 21
- Fluent in English
- CHW pre-pilot RCT participants:
- Of Chinese descent
- Fluent in Mandarin
- Male
- Livery driver
- Age 55-80 years old
- Driven for 3 months or longer
- 30 pack year history
- Current smoker or quit within 15 years
- Will not be traveling out of New York Area for more than 1 month in the next 3 months
- CHW pilot RCT participants
- Of Chinese descent
- Fluent in Mandarin or Cantonese
- Male
- Professional driver
- Age 50-80 years old
- Driven for 3 months or longer
- Last drove professionally within the last 18 months with plans of returning
- 20 pack year smoking history
- Current smoker or quit within 15 years
- Will not be traveling out of New York Area for more than 3 months in the next 12 months
- Has not completed LDCT in the past year.
Who cannot join
- Has a household member who has already participated (or agreed to participate).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to test if our Community Health Worker program can help at-risk NYC Chinese community members participate in shared decision making and lung cancer screening (if appropriate) and compare it to the help provided by written materials.
Read the detailed description
The study first used qualitative methods to inform the adaptation of a CHW model to facilitate lung cancer screening completion in an extremely high-risk group, NYC Chinese livery drivers who smoke or who quit within the past 15 years. A series of focus groups with Chinese livery drivers who smoke, a series of in-depth interviews with livery base management and staff, primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community were conducted to explore barriers and factors related to cancer screening. Findings were used to develop adapted intervention materials, including a CHW Manual for Facilitating Shared Decision Making and Lung Cancer Screening. Once adaptation is complete, the researchers will conduct a pre-pilot to refine the adapted CHW intervention materials. The researchers will then conduct a pilot randomized controlled trial (RCT) to assess the feasibility of the refined CHW model (intervention) versus written materials (control) to facilitate SDM and LCS (when appropriate) in an extremely high-risk group, NYC Chinese livery drivers eligible (by USPTSF criteria) for LCS. Feasibility results will be used to inform the planning and design of large scale RCTs, targeting Chinese drivers, as well as other driver populations in NYC and throughout the U.S., and other high risk Chinese smoking populations in other occupations (e.g. restaurant work, construction). The study is currently in the pre-pilot phase and expects to launch the pilot phase by the summer of 2020. Due to the effects of the COVID-19 crisis, the researchers have extended the pre-pilot participation time frame to 12 months. The study population has also indicated concern to attend doctor's appointments for SDM/LCS during COVID-19. As such, MSK is extending the study time frame to an additional 6 months. . CHWs will also be hosting health education workshops at community organizations, family associations, and public libraries. These workshops will be conducted in English, Mandarin, and Cantonese and cover topics including smoking cessation and lung cancer screening.
- Being tested
- Surveys, Navigation, Focus groups, In-depth interviews
- Keywords
- Professional Drivers, 16-949
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
Intake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc.
Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc.
NavigationBehavioural
CHWs facilitated SDM and LCS for drivers, providing navigation ( finding a PCP, scheduling appointments, assisting with insurance, etc.), following up on results and next steps.
Focus groupsBehavioural
Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).
In-depth interviewsBehavioural
Interviews with Chinese livery bases elicited perspectives on adapting the CWH model for the drivers' occupational environment.
Interviews with PCPs, clinic directors, etc. serving Chinese communities provided insight into adapting the CHW model within the health care context.
| Study group | Role | What they receive |
|---|---|---|
| Pilot RCT Control Group | Active comparator | Eligible NYC Chinese livery drivers will receive written materials only Receives: Behavioral: Surveys |
| Pilot RCT CHW Intervention Group | Experimental | Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS). Receives: Behavioral: Surveys; Behavioral: Navigation |
| Focus Group | Experimental | The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke. Receives: Behavioral: Focus groups |
| In-Depth Interview Group | Experimental | 12-15 in-depth interviews with livery base management and staff, and with 12-15 primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community. Receives: Behavioral: In-depth interviews |
| Pre-pilot Group | Experimental | Approximately 10 Chinese livery drivers who smoke or who quit smoking with the past 15 years and have a 30 pack-year history of smoking Receives: Behavioral: Surveys; Behavioral: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Pre-Pilot Phase) Increased uptake in SDM and LCS
To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT.
Measured: 2 years
(Pilot Phase) Increased uptake in SDM and LCS
To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start1 Aug 2016
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
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 Memorial Sloan Kettering Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Leng, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914899
- Sponsor's protocol ID
- 16-949
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2016
- Last updated
- 21 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
- ClinicalTrials.gov ID
- NCT02914899
- Acronym / sponsor ID
- 16-949
- Keywords
- Professional Drivers, 16-949
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
The purpose of this study is to test if our Community Health Worker program can help at-risk NYC Chinese community members participate in shared decision making and lung cancer screening (if appropriate) and compare it to the help provided by written materials.
Detailed description
The study first used qualitative methods to inform the adaptation of a CHW model to facilitate lung cancer screening completion in an extremely high-risk group, NYC Chinese livery drivers who smoke or who quit within the past 15 years. A series of focus groups with Chinese livery drivers who smoke, a series of in-depth interviews with livery base management and staff, primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community were conducted to explore barriers and factors related to cancer screening. Findings were used to develop adapted intervention materials, including a CHW Manual for Facilitating Shared Decision Making and Lung Cancer Screening. Once adaptation is complete, the researchers will conduct a pre-pilot to refine the adapted CHW intervention materials. The researchers will then conduct a pilot randomized controlled trial (RCT) to assess the feasibility of the refined CHW model (intervention) versus written materials (control) to facilitate SDM and LCS (when appropriate) in an extremely high-risk group, NYC Chinese livery drivers eligible (by USPTSF criteria) for LCS. Feasibility results will be used to inform the planning and design of large scale RCTs, targeting Chinese drivers, as well as other driver populations in NYC and throughout the U.S., and other high risk Chinese smoking populations in other occupations (e.g. restaurant work, construction). The study is currently in the pre-pilot phase and expects to launch the pilot phase by the summer of 2020. Due to the effects of the COVID-19 crisis, the researchers have extended the pre-pilot participation time frame to 12 months. The study population has also indicated concern to attend doctor's appointments for SDM/LCS during COVID-19. As such, MSK is extending the study time frame to an additional 6 months. . CHWs will also be hosting health education workshops at community organizations, family associations, and public libraries. These workshops will be conducted in English, Mandarin, and Cantonese and cover topics including smoking cessation and lung cancer screening.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pilot RCT Control Group | Active comparator | Behavioral: SurveysEligible NYC Chinese livery drivers will receive written materials only |
| Pilot RCT CHW Intervention Group | Experimental | Behavioral: Surveys, Behavioral: NavigationEligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS). |
| Focus Group | Experimental | Behavioral: Focus groupsThe investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke. |
| In-Depth Interview Group | Experimental | Behavioral: In-depth interviews12-15 in-depth interviews with livery base management and staff, and with 12-15 primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community. |
| Pre-pilot Group | Experimental | Behavioral: Surveys, Behavioral: NavigationApproximately 10 Chinese livery drivers who smoke or who quit smoking with the past 15 years and have a 30 pack-year history of smoking |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Of Chinese descent
- Non-U.S. born
- Fluent in Mandarin
- Livery driver
- Age 45-80
Key exclusion criteria (1 listed)
- Has a household member who has already participated (or agreed to participate).
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 |
|---|---|---|
| SurveysIntake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc. Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc. | Behavioural | Pilot RCT CHW Intervention Group, Pilot RCT Control Group, Pre-pilot Group |
| NavigationCHWs facilitated SDM and LCS for drivers, providing navigation ( finding a PCP, scheduling appointments, assisting with insurance, etc.), following up on results and next steps. | Behavioural | Pilot RCT CHW Intervention Group, Pre-pilot Group |
| Focus groupsGained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS). | Behavioural | Focus Group |
| In-depth interviewsInterviews with Chinese livery bases elicited perspectives on adapting the CWH model for the drivers' occupational environment. Interviews with PCPs, clinic directors, etc. serving Chinese communities provided insight into adapting the CHW model within the health care context. | Behavioural | In-Depth Interview Group |
Primary outcome
(Pre-Pilot Phase) Increased uptake in SDM and LCS
Time frame: 2 years
To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT.
(Pilot Phase) Increased uptake in SDM and LCS
Time frame: 2 years
To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT.
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 21 Nov 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jennifer Leng, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Surveys, Navigation and Focus groups in people with Lung Cancer Screening and Current or Past Cigarette Smoker, run by Memorial Sloan Kettering Cancer Center 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 39 inclusion and 1 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 21 Nov 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
(Pre-Pilot Phase) Increased uptake in SDM and LCS (time frame: 2 years). The study lists 2 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 21 Nov 2025.