Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:02 PM
Study NCT ID:
NCT05447156
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2022-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
QuitGuide for American Indians: Aims 2 & 3
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcarroll@umn.edu', 'phone': '612-624-4511', 'title': 'Dana Mowls Carroll, Ph.D., M.P.H.', 'organization': 'Masonic Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of App Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'title': '5 weeks post enrollment', 'categories': [{'measurements': [{'value': '15.3', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': '1 week post randomization', 'categories': [{'measurements': [{'value': '4.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks post enrollment and 1 week post randomization', 'description': 'The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization.', 'unitOfMeasure': 'App initiations per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 weeks post enrollment aim 3', 'description': 'Percentage of randomized participants that complete the final phone interview at 5 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 weeks post enrollment aim 3', 'description': 'Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Usability of App Design Measured Using System Usability Scale (SUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks post enrollment', 'description': 'Scores for each question (1-5) are added together for an overall score of 100. 100 means the website is rated at optimal usability. Scores lower than 100 indicate the website needs improvements. Mean and standard deviations or medians and ranges of percentile rankings will be calculated. Minimum score of zero.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability of Overall App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks post enrollment', 'description': "Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'How likely would you be to recommend the app to a friend?'. Rated out of 7 points. 7 is the highest score, indicating participants are very likely to recommend the app to a friend. Scores lower than 7 indicate participants are less likely to recommend the app. Minimum score of zero.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fit of App With Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'OG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks post enrollment', 'description': "Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'The app fits my American Indian culture such as its history, traditions, and customs'. Rated out of 7 points. 7 is the highest score, indicating participants feel app fits the American Indian culture. Scores lower than 7 indicate participants don't feel as strongly that app fits American Indian culture. Minimum score of zero.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'FG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.\n\nTailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.'}, {'id': 'BG001', 'title': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.\n\nStandard QuitGuide app: This is an app available to the public.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex not reported for one participant.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-16', 'size': 428240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T15:24', 'hasProtocol': True}, {'date': '2022-11-23', 'size': 4893137, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-23T11:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2022-07-01', 'resultsFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-25', 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of App Use', 'timeFrame': '5 weeks post enrollment and 1 week post randomization', 'description': 'The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization.'}], 'secondaryOutcomes': [{'measure': 'Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks', 'timeFrame': '5 weeks post enrollment aim 3', 'description': 'Percentage of randomized participants that complete the final phone interview at 5 weeks'}, {'measure': 'Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview', 'timeFrame': '5 weeks post enrollment aim 3', 'description': 'Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention)'}, {'measure': 'Usability of App Design Measured Using System Usability Scale (SUS)', 'timeFrame': '5 weeks post enrollment', 'description': 'Scores for each question (1-5) are added together for an overall score of 100. 100 means the website is rated at optimal usability. Scores lower than 100 indicate the website needs improvements. Mean and standard deviations or medians and ranges of percentile rankings will be calculated. Minimum score of zero.'}, {'measure': 'Acceptability of Overall App', 'timeFrame': '5 weeks post enrollment', 'description': "Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'How likely would you be to recommend the app to a friend?'. Rated out of 7 points. 7 is the highest score, indicating participants are very likely to recommend the app to a friend. Scores lower than 7 indicate participants are less likely to recommend the app. Minimum score of zero."}, {'measure': 'Fit of App With Culture', 'timeFrame': '5 weeks post enrollment', 'description': "Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'The app fits my American Indian culture such as its history, traditions, and customs'. Rated out of 7 points. 7 is the highest score, indicating participants feel app fits the American Indian culture. Scores lower than 7 indicate participants don't feel as strongly that app fits American Indian culture. Minimum score of zero."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Indian person based on self-report\n* Age ≥ 18 years\n* Interested in quitting smoking\n* Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days\n\n o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product\n* Smartphone ownership with the ability to download applications and sufficient data to complete research procedures\n\nExclusion Criteria:\n\n* New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month\n* Does not speak or read English'}, 'identificationModule': {'nctId': 'NCT05447156', 'briefTitle': 'QuitGuide for American Indians: Aims 2 & 3', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'QuitGuide for American Indians: Aims 2 & 3', 'orgStudyIdInfo': {'id': 'SPH-2022-30604'}, 'secondaryIdInfos': [{'id': 'MCC CPRC', 'type': 'OTHER', 'domain': '2022LS018'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aim 3:Tailored App', 'description': 'Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.', 'interventionNames': ['Behavioral: Tailored QuitGuide app']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aim 3: Standard App', 'description': 'Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.', 'interventionNames': ['Behavioral: Standard QuitGuide app']}], 'interventions': [{'name': 'Tailored QuitGuide app', 'type': 'BEHAVIORAL', 'description': 'This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.', 'armGroupLabels': ['Aim 3:Tailored App']}, {'name': 'Standard QuitGuide app', 'type': 'BEHAVIORAL', 'description': 'This is an app available to the public.', 'armGroupLabels': ['Aim 3: Standard App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center - University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Dana Caroll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, Univeristy of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}