Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT07049757
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}, {'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 760}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who have quit smoking at 6 months', 'timeFrame': '6 months', 'description': 'The smoking cessation rate is defined as the proportion of smokers who report quitting smoking, with biochemically verified 30-day point prevalent abstinence at the 6-month follow-up. Smoking rates will be reported by arm.'}], 'secondaryOutcomes': [{'measure': 'Change in levels of tobacco smoke biomarkers for second-(SHS)hand smoke exposure', 'timeFrame': 'Up to 6 months', 'description': 'The change in level of tobacco smoke exposure will be assessed among non-smoking family/household members by reviewing levels of urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) at baseline and at 6 months.'}, {'measure': 'Proportion of participants who have quit smoking at 12 months', 'timeFrame': 'Up to 12 months', 'description': 'The smoking cessation rate is defined as the proportion of smokers who report quitting smoking, with verified 30-day point prevalent abstinence by biochemical markers (e.g., urinary NNAL and cotinine tests) at the 12-month follow-up. Smoking rates will be reported by arm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Third-hand Smoke'], 'conditions': ['Tobacco-Related Carcinoma', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether the Smokefree Family Living (SFL) intervention improves quit rates (smoking cessation) and exposure to tobacco contamination that stays in items such as, carpets, walls, and furniture, even after the smoke has cleared (third-hand smoke (THS)) among Chinese American smokers and their non-smoking household members. Smoking remains high among Chinese American males with limited ability to speak English. This causes the non-smoking household members to be exposed to THS, which contains many of the same harmful components as smoking and becomes more toxic as it ages. SFL is tailored for Chinese Americans and combines the contents of the Quit Smoking for a Healthy Family (QS) intervention with additional THS education and cleaning strategies. QS focuses on smoking cessation through educational sessions and support. THS education and cleaning strategies provide information on THS and how to clean the home for THS. SFL may help Chinese American smokers and their non-smoking household members learn about the importance of quitting and the dangers of THS, this may improve smoking cessation and reduce THS exposure', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum with the third-hand smoke education and cleaning intervention (THS) into a new intervention titled "Smokefree Family Living" (SFL) for Chinese immigrant families and household members.\n\nII. Examine the efficacy of SFL by measuring smoking cessation rates at six months and the reduction in third-hand smoke exposure among smokers and nonsmoking household member participants, respectively, using a 2-arm randomized trial targeting 320 smoker-household member dyads from the Chinese American communities.\n\nSECONDARY OBJECTIVE:\n\nI. Examine individual and social pathways mediating the outcomes for cessation attempts, abstinence, and tobacco smoke exposure.\n\nEXPLORATORY OBJECTIVES:\n\nI. Explore the long-term impacts of the THS education and the timing of the accessibility of the THS intervention by examining time to first 30-day quit attempts and duration of quit attempts after exposure to THS intervention in both intervention groups of a subsample available for 12-month follow-up.\n\nII. To compare the long-term efficacy of the SFL and QS interventions in sustaining smoking cessation and reducing tobacco smoke exposure.\n\nIII. To evaluate the feasibility and effectiveness of using silicone wristbands to measure third-hand smoke (THS) exposure among non-smoking household members of Chinese American smokers participating in the study.\n\nIV. Assess the behavioral changes related to smoking and smoke exposure, as well as the psychosocial impact of the interventions on participants and their household members.\n\nOUTLINE:\n\nA family-based intervention development phase prior to the randomized study will integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum of the Healthy Family Project with the third-hand smoke education and cleaning intervention (THS) into a newly integrated intervention named "Smokefree Family Living" (SFL) for Chinese immigrant families and household members. Information collected from this group will be used to refine and develop the final SFL intervention used in the subsequent clinical trial. These participants will not be included in final study analyses.\n\nParticipants enrolled after the focus group data has been evaluated for implementation will be randomized to 1 of 2 arms.\n\nARM I: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months. Additionally, participants undergo urine sample collection throughout the study.\n\nARM II: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study.\n\nAfter completion of study intervention, participants are followed up at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Participants (Lay Health Workers, Smokers, Family Participants, and Post-Trial Household Member Group Interview Participants):\n\n1. Must be 18 years of age or older.\n2. Must self-identify as Chinese or of Chinese descent (ethnic or cultural identification, not national origin).\n3. Must be able to understand in spoken Chinese (Cantonese and/or Mandarin) or English.\n4. Able to attend educational sessions in person or via video conferencing.\n5. Ability to understand and the willingness to sign a written informed consent document.\n\nLay Health Workers:\n\n1. Must have experience or interest in community outreach and education.\n2. Must demonstrate proficiency in language (Cantonese and/or Mandarin or English) sufficient to deliver study materials and interact with participants.\n3. Must be affiliated with the Chinese Community Health Resource Center (CCHRC) or recruited through community networks.\n4. Must agree to participate in training and intervention delivery activities as outlined in the study protocol.\n\nSmokers (Participants who are current smokers):\n\n1. Must have smoked within the past 30 days, either daily or occasionally.\n2. Must have a non-smoking household member.\n\nFamily Participants (Non-smoking family/household members):\n\n1. Must live in the same household as the smoker participant.\n2. Must not have used any tobacco products in the past 30 days.\n\nPost-Trial Household Member Group Interview Participants:\n\n1\\. Living in the same household with the smoker-household member dyad participant being interviewed or considered as a household member.\n\nExclusion Criteria:\n\nLay Health Workers, Smokers (Participants who are current smokers) and Family Participants (Non-smoking Family/household members):\n\n1. Currently participating in another smoking cessation program.\n2. Non-residents of California.\n3. Participants unwilling to provide follow-up contact for assessments at 6 and 12 months.\n\nLay Health Workers:\n\n1. Lack of willingness or ability to complete training or deliver intervention sessions as required by the study protocol.\n2. Inability to maintain confidentiality and professionalism during interactions with study participants.\n3. Active participation in conflicting research studies or programs.'}, 'identificationModule': {'nctId': 'NCT07049757', 'briefTitle': 'Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Healthy Family Project: Ending Tobacco Use and Smoke Exposure in Asian American Communities', 'orgStudyIdInfo': {'id': '24634'}, 'secondaryIdInfos': [{'id': 'NCI-2025-00206', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Development (Focus group + Interview)', 'description': 'To achieve information gathering and preliminary adaptation design to prepare for the randomized clinical trial, focus groups and individual interviews with 24 participants (6 Chinese current smokers; 6 former smokers who have stopped smoking within the past 2 years; and 12 family/household members living with a current/former smoker) to review the newly developed or updated intervention materials. The Community Advisory Board (CAB) will also be involved in providing input.', 'interventionNames': ['Other: Focus Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I: Quit Smoking for a Healthy Family Group (QS)', 'description': 'Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months after the initial QS curriculum. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.', 'interventionNames': ['Other: Smoking cessation education', 'Behavioral: Survey Administration', 'Behavioral: Telephone-Based Intervention', 'Procedure: Urine Specimen Collection', 'Other: Silicone Wrist Band', 'Other: Interview']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II: Smokefree Family Living Group (SFL)', 'description': 'Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.', 'interventionNames': ['Other: Smoking cessation education', 'Behavioral: Survey Administration', 'Behavioral: Telephone-Based Intervention', 'Procedure: Urine Specimen Collection', 'Other: Silicone Wrist Band', 'Other: Interview']}], 'interventions': [{'name': 'Smoking cessation education', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education'], 'description': 'Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Survey Administration', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaires'], 'description': 'Administered for ancillary studies', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Telephone-Based Follow-up'], 'description': 'Participants will receive follow-up calls', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Urine Specimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Urine Sample'], 'description': 'Undergo urine sample collection at baseline', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Silicone Wrist Band', 'type': 'OTHER', 'description': 'Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Interview', 'type': 'OTHER', 'otherNames': ['In-depth interview'], 'description': 'Selected participants will take part in an interview for ancillary studies', 'armGroupLabels': ['Arm I: Quit Smoking for a Healthy Family Group (QS)', 'Arm II: Smokefree Family Living Group (SFL)']}, {'name': 'Focus Group', 'type': 'OTHER', 'description': 'Participants will review and comment on materials under development to be used in randomized clinical trial.', 'armGroupLabels': ['Intervention Development (Focus group + Interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edgar Yu', 'role': 'CONTACT', 'email': 'edgar.yu@ucsf.edu'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}, {'name': 'Janice Tsoh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joyce Cheng, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Edgar Yu', 'role': 'CONTACT', 'email': 'edgar.yu@ucsf.edu', 'phone': '877-827-3222'}], 'overallOfficials': [{'name': 'Janice Tsoh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tobacco Related Disease Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}