Viewing Study NCT03224520


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Study NCT ID: NCT03224520
Status: COMPLETED
Last Update Posted: 2021-03-26
First Post: 2017-06-21
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rajani.sadasivam@umassmed.edu', 'phone': '508-856-8923', 'title': 'Rajani Sadasivam', 'organization': 'University of Massachusetts Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Our study was an anonymous online smoking cessation intervention there were no risks to participants physical health associated with Decide2Quit. There was no possibility or risk for mortality associated with participation in our study. All-Cause Mortality, Serious, and Other (not including serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '199', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'OG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'classes': [{'categories': [{'title': "Haven't smoked in last 7 days", 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'Smoked in the last 7 days', 'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months post registration', 'description': "Smoking cessation measured by the 7-day point prevalence question:\n\nSix month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)?\n\n* Yes\n* No\n* Don't know/not sure\n* Refused", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Number of Cigarettes Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}, {'value': '372', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'OG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.60', 'spread': '10.81', 'groupId': 'OG000'}, {'value': '-7.95', 'spread': '10.15', 'groupId': 'OG001'}, {'value': '-10.63', 'spread': '9.99', 'groupId': 'OG002'}, {'value': '-9.08', 'spread': '11.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months post registration', 'description': 'Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline.', 'unitOfMeasure': 'cigarettes a day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeated Use of Decide2Quit Functions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'OG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'classes': [{'title': 'No Use', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}]}, {'title': '1 or 2 Functions Used', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Greater than 2 Functions Used', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout study (tracked for 6 months post registration)', 'description': 'As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: \\> 2 functions used).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population limited to participants who visited Decide2Quit more than one time.'}, {'type': 'SECONDARY', 'title': 'Recruitment of African Americans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}, {'value': '372', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'OG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline Registration', 'description': 'This is measured by the proportion of African Americans in each treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recruitment Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}, {'value': '373', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'OG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'OG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'classes': [{'categories': [{'measurements': [{'value': '377.22', 'spread': '135.80', 'groupId': 'OG000'}, {'value': '379.29', 'spread': '133.32', 'groupId': 'OG001'}, {'value': '383.98', 'spread': '136.84', 'groupId': 'OG002'}, {'value': '367.28', 'spread': '134.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline Registration', 'description': "Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days).", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'FG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'FG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'FG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '370'}, {'groupId': 'FG002', 'numSubjects': '374'}, {'groupId': 'FG003', 'numSubjects': '372'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '184'}, {'groupId': 'FG003', 'numSubjects': '173'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '370', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}, {'value': '372', 'groupId': 'BG003'}, {'value': '1487', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fully Enhanced', 'description': "Peer recruitment and recommender CTHC\n\nRecommender CTHC: Enhanced Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'BG001', 'title': 'Recommender CTHC Only', 'description': 'Recommender CTHC and standard online recruitment\n\nRecommender CTHC: Enhanced Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'BG002', 'title': 'Peer Recruitment Only', 'description': "Peer recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nPeer Recruitment: Tools to facilitate smokers' recruiting their peers"}, {'id': 'BG003', 'title': 'Standard', 'description': 'Standard online recruitment and standard CTHC\n\nStandard CTHC: Standard Messaging\n\nStandard Online Recruitment: Search Engine and Social Media Advertisements'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}, {'value': '1360', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}, {'value': '1101', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '386', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}, {'value': '1291', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}, {'value': '1167', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Cigarettes Smoked per day', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': '>0 & <=10 Cigarettes', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '458', 'groupId': 'BG004'}]}, {'title': '>10 & <=20 Cigarettes', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '663', 'groupId': 'BG004'}]}, {'title': '>20 Cigarettes', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '306', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'categories': [{'title': 'Already quit', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}, {'title': 'Thinking about quitting', 'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}, {'value': '1182', 'groupId': 'BG004'}]}, {'title': 'Not thinking about quitting', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-30', 'size': 1645541, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-22T13:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Using a 2×2 factorial design, we will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group that was demonstrated to be effective in our previous trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2017-06-21', 'resultsFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-22', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Cessation', 'timeFrame': 'At 6 months post registration', 'description': "Smoking cessation measured by the 7-day point prevalence question:\n\nSix month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)?\n\n* Yes\n* No\n* Don't know/not sure\n* Refused"}], 'secondaryOutcomes': [{'measure': 'Change in the Number of Cigarettes Smoked', 'timeFrame': 'At 6 months post registration', 'description': 'Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline.'}, {'measure': 'Repeated Use of Decide2Quit Functions', 'timeFrame': 'Throughout study (tracked for 6 months post registration)', 'description': 'As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: \\> 2 functions used).'}, {'measure': 'Recruitment of African Americans', 'timeFrame': 'At Baseline Registration', 'description': 'This is measured by the proportion of African Americans in each treatment arm'}, {'measure': 'Recruitment Time', 'timeFrame': 'At Baseline Registration', 'description': "Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '39334264', 'type': 'DERIVED', 'citation': 'Lee DN, Faro JM, Stevens EM, Pbert L, Yang C, Sadasivam RS. Stopping use of E-cigarettes and smoking combustible cigarettes: findings from a large longitudinal digital smoking cessation intervention study in the United States. BMC Res Notes. 2024 Sep 27;17(1):276. doi: 10.1186/s13104-024-06939-w.'}, {'pmid': '36633844', 'type': 'DERIVED', 'citation': 'Faro JM, Chen J, Flahive J, Nagawa CS, Orvek EA, Houston TK, Allison JJ, Person SD, Smith BM, Blok AC, Sadasivam RS. Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250665. doi: 10.1001/jamanetworkopen.2022.50665.'}, {'pmid': '34563161', 'type': 'DERIVED', 'citation': 'Chen J, Houston TK, Faro JM, Nagawa CS, Orvek EA, Blok AC, Allison JJ, Person SD, Smith BM, Sadasivam RS. Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement. BMC Public Health. 2021 Sep 26;21(1):1749. doi: 10.1186/s12889-021-11803-8.'}, {'pmid': '33571687', 'type': 'DERIVED', 'citation': 'Faro JM, Nagawa CS, Orvek EA, Smith BM, Blok AC, Houston TK, Kamberi A, Allison JJ, Person SD, Sadasivam RS. Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov. Contemp Clin Trials. 2021 Apr;103:106314. doi: 10.1016/j.cct.2021.106314. Epub 2021 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'The research study, "Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions" will test two smoker-driven, social marketing innovations to recruit and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective "Digital Intervention for Smoking Cessation".', 'detailedDescription': "S2S has many innovations that are designed to utilize the power of peers and social networks for dissemination. These include: Peer recruitment: Tools to facilitate smokers' recruiting their peers to increase Decide2Quit access; and a recommender computer tailored health communication (recommender CTHC): a Complex machine learning algorithm (recommender systems) that uses smokers' feedback (explicit and implicit) in the current and prior studies to adapt its selection of messages to smokers.\n\nUsing a 2×2 factorial design, the study will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of Age or older\n* Current smoker\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Non-smoker'}, 'identificationModule': {'nctId': 'NCT03224520', 'briefTitle': 'Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco', 'orgStudyIdInfo': {'id': 'CDR-1603-34645'}, 'secondaryIdInfos': [{'id': 'CDR160334645', 'type': 'OTHER_GRANT', 'domain': 'Patient-Centered Outcomes Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fully enhanced', 'description': 'Peer recruitment and recommender CTHC', 'interventionNames': ['Behavioral: Recommender CTHC', 'Other: Peer Recruitment']}, {'type': 'EXPERIMENTAL', 'label': 'Recommender CTHC only', 'description': 'Recommender CTHC and standard online recruitment', 'interventionNames': ['Behavioral: Recommender CTHC', 'Other: Standard Online Recruitment']}, {'type': 'EXPERIMENTAL', 'label': 'Peer recruitment only', 'description': 'Peer recruitment and standard CTHC', 'interventionNames': ['Behavioral: Standard CTHC', 'Other: Peer Recruitment']}, {'type': 'EXPERIMENTAL', 'label': 'Standard', 'description': 'Standard online recruitment and standard CTHC', 'interventionNames': ['Behavioral: Standard CTHC', 'Other: Standard Online Recruitment']}], 'interventions': [{'name': 'Recommender CTHC', 'type': 'BEHAVIORAL', 'description': 'Enhanced Messaging', 'armGroupLabels': ['Fully enhanced', 'Recommender CTHC only']}, {'name': 'Standard CTHC', 'type': 'BEHAVIORAL', 'description': 'Standard Messaging', 'armGroupLabels': ['Peer recruitment only', 'Standard']}, {'name': 'Peer Recruitment', 'type': 'OTHER', 'description': "Tools to facilitate smokers' recruiting their peers", 'armGroupLabels': ['Fully enhanced', 'Peer recruitment only']}, {'name': 'Standard Online Recruitment', 'type': 'OTHER', 'description': 'Search Engine and Social Media Advertisements', 'armGroupLabels': ['Recommender CTHC only', 'Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Rajani Sadasivam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rajani Sadasivam', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}