Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT04084561
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2019-09-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk Communication in African American Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'grace.ma@temple.edu', 'phone': '215-707-6493', 'title': 'Dr. Grace X. Ma', 'organization': 'Center for Asian Health, Temple University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study examined the effects of communicating hypothetical genetic results to patients on their motivation to quit smoking. Future research needs to study effects of actual genetic risk communication, and its effects on actual smoking cessation behavior, rather than motivation to quit. Nevertheless the results suggest communicating elevated risk of lung cancer may increase motivation to quit smoking.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'HRHA', 'description': 'High Risk, High Ancestry\n\nHRHA: participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\\~90%).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LRLA', 'description': 'Low Risk, Low Ancestry\n\nLRLA: participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\\~10%).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'HRLA', 'description': 'High Risk, Low Ancestry\n\nHRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'LRHA', 'description': 'Low Risk, High Ancestry\n\nLRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Motivation to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HRHA', 'description': 'High Risk, High Ancestry\n\nHRHA: participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\\~90%).'}, {'id': 'OG001', 'title': 'LRLA', 'description': 'Low Risk, Low Ancestry\n\nLRLA: participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\\~10%).'}, {'id': 'OG002', 'title': 'HRLA', 'description': 'High Risk, Low Ancestry\n\nHRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical'}, {'id': 'OG003', 'title': 'LRHA', 'description': 'Low Risk, High Ancestry\n\nLRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical'}], 'classes': [{'categories': [{'measurements': [{'value': '4.95', 'spread': '.296', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '.254', 'groupId': 'OG001'}, {'value': '5.49', 'spread': '.261', 'groupId': 'OG002'}, {'value': '4.52', 'spread': '.284', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute after intervention', 'description': 'use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition; range of scale : 1-7, with higher score means higher motivation to quit smoking', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HRHA', 'description': 'High Risk, High Ancestry\n\nHRHA: participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\\~90%).'}, {'id': 'FG001', 'title': 'LRLA', 'description': 'Low Risk, Low Ancestry\n\nLRLA: participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\\~10%).'}, {'id': 'FG002', 'title': 'HRLA', 'description': 'High Risk, Low Ancestry\n\nHRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical'}, {'id': 'FG003', 'title': 'LRHA', 'description': 'Low Risk, High Ancestry\n\nLRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Because of COVID, and with the consent of the funding agency and IRB, we opened a second IRB to JUST do Aim 3. So Aim 3 is independent and it is the only part that was a clinical trial. This sample consisted of 166 respondents.', 'preAssignmentDetails': 'Aim3 was the clinical trial component. We were initially informed by clinical trials staff that we should include enrollment numbers for ALL of the aims. Then we were informed to include only those recruited to Aim 3. Although the original goal was to recruit participants from Aims 1 and 2 to do Aim 3, COVID-19 made that impossible. Thus, with consent of the funding agency and IRB, we pivoted to collect the Aim 3 data remotely in an independent sample. This sample consisted of 166 respondents.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '166', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'HRHA', 'description': 'High Risk, High Ancestry\n\nHRHA: participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\\~90%).'}, {'id': 'BG001', 'title': 'LRLA', 'description': 'Low Risk, Low Ancestry\n\nLRLA: participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\\~10%).'}, {'id': 'BG002', 'title': 'HRLA', 'description': 'High Risk, Low Ancestry\n\nHRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical'}, {'id': 'BG003', 'title': 'LRHA', 'description': 'Low Risk, High Ancestry\n\nLRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.80', 'spread': '13.478', 'groupId': 'BG000'}, {'value': '43.24', 'spread': '13.821', 'groupId': 'BG001'}, {'value': '41.58', 'spread': '15.462', 'groupId': 'BG002'}, {'value': '37.62', 'spread': '14.629', 'groupId': 'BG003'}, {'value': '41.28', 'spread': '14.428', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Americans', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '166', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-20', 'size': 210389, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-05T16:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2019-09-06', 'resultsFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2019-09-06', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-27', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation to Quit Smoking', 'timeFrame': '1 minute after intervention', 'description': 'use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition; range of scale : 1-7, with higher score means higher motivation to quit smoking'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Participants will be given hypothetical personalized genetic risk results and ask to think about how they might respond to such information if they actually received such results.", 'detailedDescription': "The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Smokers will be randomized to receive hypothetical information about their genetic status and consider how they think they would respond if such results were actually presented to them. They will be randomly assigned to receive one of four sets of hypothetical genetic results: 1) High risk of lung cancer and high genetic African ancestry, 2) High risk of lung cancer and low genetic African ancestry, 3) Low risk of lung cancer and high genetic African ancestry, or 4) Low risk of lung cancer and low genetic African ancestry. After being given this hypothetical information, participants will complete brief questionnaires assessing perceived risk of lung cancer, worry about cancer, psychological distress, and motivation to quit smoking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age minimum\n* Self-report African American\n* Report smoking at least 100 lifetime cigarettes\n\nExclusion Criteria:\n\n* Report history of cancer'}, 'identificationModule': {'nctId': 'NCT04084561', 'briefTitle': 'Risk Communication in African American Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Nicotine Dependence and Lung Cancer Genetics in African Americans', 'orgStudyIdInfo': {'id': '18-8004'}, 'secondaryIdInfos': [{'id': '1U54CA221705-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U54CA221705-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRHA', 'description': 'High Risk, High Ancestry', 'interventionNames': ['Behavioral: HRHA']}, {'type': 'EXPERIMENTAL', 'label': 'LRLA', 'description': 'Low Risk, Low Ancestry', 'interventionNames': ['Behavioral: LRLA']}, {'type': 'EXPERIMENTAL', 'label': 'HRLA', 'description': 'High Risk, Low Ancestry', 'interventionNames': ['Behavioral: HRLA']}, {'type': 'EXPERIMENTAL', 'label': 'LRHA', 'description': 'Low Risk, High Ancestry', 'interventionNames': ['Behavioral: LRHA']}], 'interventions': [{'name': 'HRHA', 'type': 'BEHAVIORAL', 'description': 'participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\\~90%).', 'armGroupLabels': ['HRHA']}, {'name': 'LRLA', 'type': 'BEHAVIORAL', 'description': 'participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\\~10%).', 'armGroupLabels': ['LRLA']}, {'name': 'HRLA', 'type': 'BEHAVIORAL', 'description': 'participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical', 'armGroupLabels': ['HRLA']}, {'name': 'LRHA', 'type': 'BEHAVIORAL', 'description': 'participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical', 'armGroupLabels': ['LRHA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hunter College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Camille Ragin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}