Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04079556
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2019-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Breast Cancer Risk in Korean American Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SHS exposure of non-smokers', 'timeFrame': '3-month', 'description': 'biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)'}], 'secondaryOutcomes': [{'measure': "Smoker's adoption of smoke-free rules", 'timeFrame': '3-month', 'description': 'Self-report of adoption of smoke-free home or car rules since program initiation'}, {'measure': "Smoker's Utilization of smoking cessation resources", 'timeFrame': '3-month', 'description': 'Use of evidence-based smoking cessation resources since program initiation'}, {'measure': 'Smoking Abstinence', 'timeFrame': '3-month', 'description': 'biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondhand Tobacco Smoke Exposure Reduction']}, 'descriptionModule': {'briefSummary': '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:\n\nH. Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Recruiting for male smokers and female household partner.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identified as Korean or Korean American;\n* Korean speaking;\n* reside in the San Francisco Bay Area\n* plan to stay in the area for the next 3 months\n* 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.\n* for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.\n* provide a valid contact telephone number for pre- and post-intervention assessments'}, 'identificationModule': {'nctId': 'NCT04079556', 'briefTitle': 'Reducing Breast Cancer Risk in Korean American Women', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Reducing Breast Cancer Risk in Korean American Women', 'orgStudyIdInfo': {'id': 'CBCRP 23AB-1400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobacco LHW', 'description': 'Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.', 'interventionNames': ['Behavioral: Tobacco LHW']}], 'interventions': [{'name': 'Tobacco LHW', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Tobacco LHW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Korean Community Center of the East Bay', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}], 'overallOfficials': [{'name': 'Janice Y Tsoh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Community Center of the East Bay', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}