Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06945120
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACT Lung Health Intervention: Phase Two
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)', 'timeFrame': '6 months post-baseline assessment', 'description': 'The proportion of participants who have not smoked cigarettes (not even a puff) in the past 7 days at the 6-month follow-up, verified biochemically using salivary cotinine testing. Participants reporting abstinence and not using nicotine replacement therapy (NRT) will perform a salivary cotinine test observed via video call. Cotinine levels ≤3 ng/mL will confirm abstinence.'}, {'measure': 'Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)', 'timeFrame': '6 months post-baseline assessment', 'description': 'The proportion of participants who have not smoked cigarettes (not even a puff) in the past 7 days at the 6-month follow-up, verified biochemically using salivary cotinine testing. Participants reporting abstinence and not using nicotine replacement therapy (NRT) will perform a salivary cotinine test observed via video call. Cotinine levels ≤3 ng/mL will confirm abstinence.'}, {'measure': 'Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)', 'timeFrame': 'Within 6 months post-baseline assessment', 'description': 'The proportion of participants who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants.'}, {'measure': 'Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)', 'timeFrame': 'Within 6 months post-baseline assessment', 'description': 'The proportion of participants who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants.'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)', 'timeFrame': 'Baseline and 6 months post-baseline assessment', 'description': 'The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.'}, {'measure': 'Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)', 'timeFrame': 'Baseline and 6 months post-baseline assessment', 'description': 'The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.'}, {'measure': 'Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)', 'timeFrame': '3 months post-baseline assessment', 'description': 'The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 3-month follow-up.'}, {'measure': 'Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)', 'timeFrame': '3 months post-baseline assessment', 'description': 'The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 3-month follow-up.'}, {'measure': 'Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)', 'timeFrame': '6 months post-baseline assessment', 'description': 'The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up.'}, {'measure': 'Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)', 'timeFrame': '6 months post-baseline assessment', 'description': 'The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Lung Cancer Screening', 'Smoking (Tobacco) Addiction', 'Smoking, Cigarette', 'Smoking, Tobacco', 'Smoking Behaviors'], 'conditions': ['Smoking Cessation', 'Smoking Behaviors', 'Smoking, Tobacco', 'Smoking, Cigarette', 'Smoking (Tobacco) Addiction']}, 'descriptionModule': {'briefSummary': 'This study aims to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.', 'detailedDescription': 'This two-arm stratified randomized clinical trial is to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.\n\nParticipants will be randomized into one of two groups: Group A: ACT Lung Health Intervention versus Group B: Standard Care. Randomization means a participant is placed into a study group by chance.\n\nThe research study procedures include screening for eligibility, questionnaires, and saliva tests.\n\nIt is expected participation in this study will last about 6 months.\n\nAbout 60 participants are expected to take part in this research study.\n\nThe National Cancer Institute is providing funding for this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as either Chinese or Korean\n* Speak either Korean, Mandarin, or English\n* Eligible for LDCT screening (50-80 years of age and 20- pack-year smoking history)\n* Currently smoking (i.e., having smoked within the prior 30 days),\n* Currently have active health insurance coverage and a primary healthcare provider and\n* Have access to a video-call device with internet or wireless connection.\n* Eastern Cooperative Oncology Group functional status \\<2\n* Live in the United States for the next 12 months\n\nExclusion Criteria:\n\n* Had LDCT screening done within the last 2 years.\n* Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months.\n* Previous history of lung cancer.\n* We will not include any of the following special populations:\n\n * Adults unable to consent.\n * Adults younger than 50 or older than 80 years\n * Individuals who are not yet adults (infants, children, teenagers)\n * Pregnant women\n * Prisoners'}, 'identificationModule': {'nctId': 'NCT06945120', 'briefTitle': 'ACT Lung Health Intervention: Phase Two', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans', 'orgStudyIdInfo': {'id': '25-041'}, 'secondaryIdInfos': [{'id': '5U54CA156734-14', 'link': 'https://reporter.nih.gov/quickSearch/5U54CA156734-14', 'type': 'NIH'}, {'id': '5U54CA156732-14', 'link': 'https://reporter.nih.gov/quickSearch/5U54CA156732-14', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: ACT Lung Health Intervention', 'description': 'Participants will be randomized 1:1 by block size and stratified by ethnicity and readiness to quit smoking and will complete:\n\n* Baseline visit\n* Questionnaires at 1, 3, and 6 months\n* 3 month saliva test\n* Weekly Zoom sessions\n* 6 month saliva test', 'interventionNames': ['Behavioral: ACT Lung Health Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Group B: Standard Care', 'description': 'Participants will be randomized 1:1 by block size and stratified by ethnicity and readiness to quit smoking and will complete:\n\n* Baseline visit\n* Questionnaires at 1, 3, and 6 months\n* 3 month saliva test\n* Weekly Zoom sessions\n* 6 month saliva test'}], 'interventions': [{'name': 'ACT Lung Health Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Asian Culturally Tailored Lung Health (ACT) Intervention'], 'description': 'An Asian culture-tailored lung health intervention, which includes individual counseling sessions, family coaching, provision of nicotine replacement therapy (NRT) in the form of patches, lozenges, or chewing gum, and educational materials about low-dose computed tomography (LDCT) for lung cancer screening. The eight weekly, counseling sessions with study staff will be conducted via phone call or the Zoom web-conferencing platform.', 'armGroupLabels': ['Group A: ACT Lung Health Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Cooley, PhD', 'role': 'CONTACT', 'email': 'Mary_cooley@dfci.harvard.edu', 'phone': '617-632-5096'}, {'name': 'Mary Cooley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Cooley, PhD', 'role': 'CONTACT', 'email': 'Mary_cooley@dfci.harvard.edu', 'phone': '617-632-5096'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Mary Cooley, PhD', 'role': 'CONTACT', 'email': 'mary_cooley@dfci.harvard.edu', 'phone': '617-632-5096'}], 'overallOfficials': [{'name': 'Mary Cooley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mary E. Cooley, Phd', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}