Reducing Breast Cancer Risk in Korean American Women

Secondhand Tobacco Smoke Exposure Reduction Clinical Trial

Official title:

Reducing Breast Cancer Risk in Korean American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079556
• Other study ID #: CBCRP 23AB-1400
• Status: Completed
• Phase: N/A
• Start date: March 16, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Secondhand Tobacco Smoke Exposure Reduction

Intervention

Behavioral:
• Tobacco LHW
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.

Locations

Country	Name	City	State
United States	Korean Community Center of the East Bay	San Leandro	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Korean Community Center of the East Bay

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Smoker's adoption of smoke-free rules	Self-report of adoption of smoke-free home or car rules since program initiation	3-month
Secondary	Smoker's Utilization of smoking cessation resources	Use of evidence-based smoking cessation resources since program initiation	3-month
Secondary	Smoking Abstinence	biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)	3-month