- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914899
Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Focus Group Participants:
- Of Chinese descent
- Non-U.S. born
- Fluent in Mandarin
- Livery driver
- Age 45-80
- 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.
Exclusion Criteria:
- Has a household member who has already participated (or agreed to participate).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pilot RCT Control Group
Eligible NYC Chinese livery drivers will receive written materials only
|
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. |
Experimental: Pilot RCT CHW Intervention Group
Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS).
|
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.
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.
|
Experimental: Focus Group
The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke.
|
Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).
|
Experimental: In-Depth Interview Group
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.
|
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. |
Experimental: Pre-pilot Group
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(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.
|
2 years
|
(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.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-949
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.
Clinical Trials on Lung Cancer Screening
-
Lanxi Hospital of Traditional Chinese MedicineZhejiang Cancer Hospital; Zhejiang Chinese Medical UniversityActive, not recruiting
-
University of GlasgowCompletedCancer ScreeningUnited Kingdom
-
Beth Israel Deaconess Medical CenterNational Cancer Institute (NCI)Completed
-
Johns Hopkins UniversityState of MarylandCompleted
-
NYU Langone HealthCenters for Disease Control and PreventionRecruitingCancer ScreeningUnited States
-
Sun Yat-sen UniversityUnknown
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedEvaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk AssessCancer | Cancer Screening Patients | Patient VolunteersUnited States
-
Centre Hospitalier Universitaire, AmiensCompletedENT Cancer ScreeningFrance
-
University of Illinois at ChicagoRecruitingLung Cancer ScreeningUnited States
-
Nanjing Shihejiyin Technology, Inc.Recruiting
Clinical Trials on Surveys
-
Memorial Sloan Kettering Cancer CenterCompletedRectal Cancer | Colon CancerUnited States
-
RANDClaremont Graduate UniversityCompleted
-
Elysium HealthUniversity of OxfordNot yet recruitingBiological Aging
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
-
University Hospital, AngersCompletedOpioid-Related Disorders | Critically Ill | Pain, ChronicFrance
-
Mayo ClinicCompletedCesarean SectionUnited States
-
Hospital for Special Surgery, New YorkCompletedPain, Postoperative | TSA | BruiseUnited States
-
Northwestern UniversityCompleted
-
Richmond University Medical CenterRecruiting