Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT06923033
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aim 1: App for Reducing Cravings to Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christine.Vinci@Moffitt.org', 'phone': '813-745-5421', 'title': 'Dr. Christine Vinci, Ph.D.', 'organization': 'Moffitt Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Aim 1: Update an Existing Smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.\n\nSmartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'System Usability Scale (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 1: Update an Existing Smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.\n\nSmartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '20.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 week', 'description': "Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'User Satisfaction (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 1: Update an Existing Smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.\n\nSmartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 week', 'description': "One Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aim 1: Update an Existing Smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.\n\nSmartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aim 1: Update an Existing Smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.\n\nSmartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-06', 'size': 901047, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T14:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-04-09', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-29', 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (Aim 1)', 'timeFrame': 'At 1 week', 'description': "Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability."}], 'secondaryOutcomes': [{'measure': 'User Satisfaction (Aim 1)', 'timeFrame': 'At 1 week', 'description': "One Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)\n* Functioning telephone number\n* Owns a smart phone capable of supporting AR and willing to download the app\n* Can speak, read and write in English\n\nExclusion Criteria:\n\n* Has another household member already enrolled in the study'}, 'identificationModule': {'nctId': 'NCT06923033', 'briefTitle': 'Aim 1: App for Reducing Cravings to Smoke', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Aim 1: Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation', 'orgStudyIdInfo': {'id': 'MCC-21980 Aim1'}, 'secondaryIdInfos': [{'id': 'R01DA055298', 'link': 'https://reporter.nih.gov/quickSearch/R01DA055298', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aim 1: Update an existing smartphone App', 'description': 'An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.', 'interventionNames': ['Behavioral: Smartphone App']}], 'interventions': [{'name': 'Smartphone App', 'type': 'BEHAVIORAL', 'description': 'Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.', 'armGroupLabels': ['Aim 1: Update an existing smartphone App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Christine Vinci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}