- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079556
Reducing Breast Cancer Risk in Korean American Women
The goals of the study are to develop a culturally and linguistically appropriate intervention to reduce SHS exposure for LEP Korean women using a family-focused intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a single group feasibility trial targeting a total of 4 lay health workers (LHW) and 24 dyads of LEP Korean women with self-reported SHS exposure at home and a male household smoker. The hypothesis is:
H. Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Leandro, California, United States, 94577
- Korean Community Center of the East Bay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- self-identified as Korean or Korean American;
- Korean speaking;
- reside in the San Francisco Bay Area
- plan to stay in the area for the next 3 months
- for women participants, the participant must report having SHS exposure at home at least 1 day in the past 7 days and live in the same household as the smoker participant to form a dyad.
- for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
- provide a valid contact telephone number for pre- and post-intervention assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tobacco LHW
Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.
|
Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach.
LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SHS exposure of non-smokers
Time Frame: 3-month
|
biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)
|
3-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoker's adoption of smoke-free rules
Time Frame: 3-month
|
Self-report of adoption of smoke-free home or car rules since program initiation
|
3-month
|
Smoker's Utilization of smoking cessation resources
Time Frame: 3-month
|
Use of evidence-based smoking cessation resources since program initiation
|
3-month
|
Smoking Abstinence
Time Frame: 3-month
|
biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)
|
3-month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Janice Y Tsoh, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CBCRP 23AB-1400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Secondhand Tobacco Smoke Exposure Reduction
-
University of California, San FranciscoCompleted
-
State University of New York - Upstate Medical...CompletedSecondhand Smoke ExposureUnited States
-
Tehran University of Medical SciencesCompletedSecondhand Smoke ExposureIran, Islamic Republic of
-
Peking Union Medical College HospitalRun Shaw Hospital, Zhejiang University School of Medicine; Hangzhou Medisol...Not yet recruitingSecondhand Smoking | Passive Smoking | Tobacco Smoke PollutionChina
-
National Institutes of Health (NIH)UnknownSmoking Cessation | Secondhand Smoke Exposure | Biomarker Feedback | Provider BehaviorUnited States
-
Boston UniversityFudan UniversityCompletedSmoking Cessation | Secondhand Smoke Exposure | Respiratory IllnessChina
-
Augusta UniversityNational Cancer Institute (NCI)CompletedTobacco Cessation | Tobacco Prevention | Environmental Tobacco Smoke ExposureUnited States
-
Tel Aviv UniversityCompletedChild Exposure to Tobacco SmokeIsrael
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); Memorial Hermann HospitalCompletedExposure to Secondhand Smoke in Neonatal InfantsUnited States
-
University of OklahomaNational Cancer Institute (NCI)CompletedSecondhand SmokeUnited States
Clinical Trials on Tobacco LHW
-
University of California, San FranciscoCompletedTobacco Use Cessation | Healthy EatingUnited States
-
NYU Langone HealthCompleted
-
Florida International UniversityCompleted
-
Tata Memorial HospitalUnknown
-
Massachusetts General HospitalPartners HealthCare, Inc.CompletedSmoking Cessation | Tobacco Use DisorderUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI); Ohio State University; Food and Drug Administration...CompletedTobacco-Related CarcinomaUnited States
-
Oregon Research Behavioral Intervention Strategies...National Institute on Drug Abuse (NIDA)Completed
-
Oregon Research Behavioral Intervention Strategies...Completed
-
Glorian SorensenHealis-Sekhsaria Institute for Public HealthCompletedTobacco Use CessationUnited States, India