Reducing Breast Cancer Risk in Korean American Women
1 other identifier
interventional
48
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 16, 2019
CompletedFirst Submitted
Initial submission to the registry
September 3, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 26, 2020
March 1, 2020
10 months
September 3, 2019
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
SHS exposure of non-smokers
biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)
3-month
Secondary Outcomes (3)
Smoker's adoption of smoke-free rules
3-month
Smoker's Utilization of smoking cessation resources
3-month
Smoking Abstinence
3-month
Study Arms (1)
Tobacco LHW
EXPERIMENTALQuit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korean Community Center of the East Bay
San Leandro, California, 94577, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Janice Y Tsoh, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2019
First Posted
September 6, 2019
Study Start
March 16, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 26, 2020
Record last verified: 2020-03