Secondhand Tobacco Smoke Exposure ReductionNCT04079556
Reducing Breast Cancer Risk in Korean American Women
A study testing Tobacco LHW in people with Secondhand Tobacco Smoke Exposure Reduction, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Secondhand Tobacco Smoke Exposure Reduction
- What is being tested?
- Tobacco LHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2019to 31 Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Community Center of the East Bay
San Leandro, California, 94577
About this study
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:
- Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?
- Being tested
- Tobacco LHW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco LHWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco LHW | Experimental | Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach. Receives: Behavioral: Tobacco LHW |
What is being measured
The primary outcome is the main question the study is designed to answer.
SHS exposure of non-smokers
biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)
Measured: 3-month
Secondary outcomes (3)
Smoker's adoption of smoke-free rules
Self-report of adoption of smoke-free home or car rules since program initiation
Measured: 3-month
Smoker's Utilization of smoking cessation resources
Use of evidence-based smoking cessation resources since program initiation
Measured: 3-month
Smoking Abstinence
biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start16 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondhand Tobacco Smoke Exposure ReductionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Community Center of the East Bay
- Responsible party
- Sponsor
- Investigators
- Janice Y Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079556
- Sponsor's protocol ID
- CBCRP 23AB-1400
- Status last verified
- Mar 2020
- First submitted
- 3 Sep 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Breast Cancer Risk in Korean American Women
- ClinicalTrials.gov ID
- NCT04079556
- Acronym / sponsor ID
- CBCRP 23AB-1400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Korean Community Center of the East Bay
- Study start
- 16 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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 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:
- Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco LHW | Experimental | Behavioral: Tobacco LHWQuit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tobacco LHWQuit 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. | Behavioural | Tobacco LHW |
Primary outcome
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 secondary outcomes
Smoker's adoption of smoke-free rules
Time frame: 3-month
Smoker's Utilization of smoking cessation resources
Time frame: 3-month
Smoking Abstinence
Time frame: 3-month
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 26 Mar 2020.
Related trials for Secondhand Tobacco Smoke Exposure Reduction
Recruiting
Implementing an Adapted Smoke-free Homes Intervention in Spain
Secondhand Tobacco Smoke Exposure Reduction, Smoking Prevention
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.
Janice Y Tsoh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco LHW in people with Secondhand Tobacco Smoke Exposure Reduction, run by University of California, San Francisco 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 7 inclusion and 0 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 26 Mar 2020. 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.
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?
SHS exposure of non-smokers (time frame: 3-month). 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 26 Mar 2020.