Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:53 PM
Study NCT ID:
NCT01923467
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lcan@med.umich.edu', 'phone': '734-763-6099', 'title': 'Larry An, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Project Quit Plus NRT Patches', 'description': "All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.\n\nProject Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.\n\nNicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.", 'otherNumAtRisk': 767, 'otherNumAffected': 0, 'seriousNumAtRisk': 767, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptance of Offer to Join Stop Smoking Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '767', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Project Quit Plus NRT Patches', 'description': "All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.\n\nProject Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.\n\nNicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Day of Enrollment', 'description': 'After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Project Quit Plus NRT Patches', 'description': "All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.\n\nProject Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.\n\nNicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Offered stop smoking program', 'groupId': 'FG000', 'numSubjects': '767'}]}, {'type': 'Baseline Completed, Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 3-month follow up survey', 'groupId': 'FG000', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '541'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'Subject non-interest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '479'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '767', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Project Quit Plus NRT Patches', 'description': "All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.\n\nProject Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.\n\nNicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '398', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '369', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '767', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Smoker recruited from an online survey panel.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 767}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2013-08-13', 'resultsFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-29', 'studyFirstPostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of Offer to Join Stop Smoking Program', 'timeFrame': '1 Day of Enrollment', 'description': 'After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking', 'nicotine replacement', 'internet'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': "This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.\n\nIn this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:\n\nAim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.\n\nAim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.\n\nAim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current smoker\n\nExclusion Criteria:\n\n* Current participation in another stop-smoking program\n* Current use of stop smoking medications\n* Pregnant or breastfeeding\n* Limited internet or email access'}, 'identificationModule': {'nctId': 'NCT01923467', 'briefTitle': 'Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program', 'orgStudyIdInfo': {'id': 'P50CA101451', 'link': 'https://reporter.nih.gov/quickSearch/P50CA101451', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project Quit plus NRT patches', 'description': 'All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.', 'interventionNames': ['Behavioral: Project Quit stop smoking program', 'Drug: Nicotine patches 21 mg']}], 'interventions': [{'name': 'Project Quit stop smoking program', 'type': 'BEHAVIORAL', 'description': "This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.", 'armGroupLabels': ['Project Quit plus NRT patches']}, {'name': 'Nicotine patches 21 mg', 'type': 'DRUG', 'otherNames': ['Nicoderm CQ Step 1 (21 mg)'], 'description': 'Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.', 'armGroupLabels': ['Project Quit plus NRT patches']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Health Communications Research, University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Lawrence C An, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Lawrence C. An', 'investigatorAffiliation': 'University of Michigan'}}}}