Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 12:50 PM
Study NCT ID:
NCT04812795
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2021-03-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andy.tan@asc.upenn.edu', 'phone': '2157466546', 'title': 'Dr. Andy Tan', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 0, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 0, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Culturally Tailored (Current Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.', 'otherNumAtRisk': 613, 'deathsNumAtRisk': 613, 'otherNumAffected': 0, 'seriousNumAtRisk': 613, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-culturally Tailored (Current Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.', 'otherNumAtRisk': 599, 'deathsNumAtRisk': 599, 'otherNumAffected': 0, 'seriousNumAtRisk': 599, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intention to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '489', 'groupId': 'OG002'}, {'value': '469', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'OG001', 'title': 'Non-culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}, {'id': 'OG002', 'title': 'Culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'OG003', 'title': 'Non-culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.814', 'spread': '5.199', 'groupId': 'OG002'}, {'value': '4.844', 'spread': '4.966', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days at baseline and 1 month follow-up.\n\nParticipants were asked to rate 4 statements: I will make an effort to quit smoking in the next 30 days (Unlikely to Likely); I intend to quit smoking in the next 30 days (Strongly disagree to Strongly Agree); I expect to quit smoking in the next 30 days (Definitely false to Definitely true); How likely is it that you will quit smoking in the next 30 days (Unlikely to Likely). Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28).\n\nThis will only be measured among current smokers. Lowest score is 4 and highest mean score is 28. Higher scores indicate increased intention to quit smoking within the next 30 days.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'U.S. young adult sexual minority women who smoked at least one cigarette in the past 30 days as baseline.'}, {'type': 'PRIMARY', 'title': 'Change in Intention to Purchase Cigarettes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '492', 'groupId': 'OG002'}, {'value': '476', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'OG001', 'title': 'Non-culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}, {'id': 'OG002', 'title': 'Culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'OG003', 'title': 'Non-culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.034', 'spread': '1.261', 'groupId': 'OG000'}, {'value': '-0.110', 'spread': '1.050', 'groupId': 'OG001'}, {'value': '-2.195', 'spread': '2.954', 'groupId': 'OG002'}, {'value': '-2.313', 'spread': '2.837', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The Juster scale was used to measure intention to purchase cigarettes at baseline and at one-month follow-up.\n\nParticipants were asked, "How likely are you to purchase cigarettes in the next 6 months?" Responses ranged from 0=No chance, almost no chance (1 in 100) to 10=Certain, practically certain (99 in 100).\n\nHigher values reflect higher intention to purchase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'U.S. young adult sexual minority women who completed the follow-up survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'FG001', 'title': 'Non-culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}, {'id': 'FG002', 'title': 'Culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'FG003', 'title': 'Non-culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}, {'groupId': 'FG001', 'numSubjects': '501'}, {'groupId': 'FG002', 'numSubjects': '613'}, {'groupId': 'FG003', 'numSubjects': '599'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '407'}, {'groupId': 'FG001', 'numSubjects': '401'}, {'groupId': 'FG002', 'numSubjects': '492'}, {'groupId': 'FG003', 'numSubjects': '476'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '123'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'BG001', 'title': 'Non-culturally Tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}, {'id': 'BG002', 'title': 'Culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.'}, {'id': 'BG003', 'title': 'Non-culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23.90', 'spread': '3.47', 'groupId': 'BG000'}, {'value': '23.7', 'spread': '3.73', 'groupId': 'BG001'}, {'value': '24.82', 'spread': '2.91', 'groupId': 'BG002'}, {'value': '24.77', 'spread': '2.90', 'groupId': 'BG003'}, {'value': '24.33', 'spread': '3.27', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Female', 'measurements': [{'value': '486', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}, {'value': '2139', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '262', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '427', 'groupId': 'BG000'}, {'value': '428', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}, {'value': '541', 'groupId': 'BG003'}, {'value': '1952', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}, {'value': '1479', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '158', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intention to quit smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '1212', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16.54', 'spread': '5.83', 'groupId': 'BG002'}, {'value': '16.35', 'spread': '5.87', 'groupId': 'BG003'}, {'value': '16.44', 'spread': '5.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'We used a 4-item scale on intention to quit smoking at baseline and at one-month follow-up among current smokers only: 1) I will make an effort to quit smoking in the next 30 days; 2) I intend to quit smoking in the next 30 days; 3) I expect to quit smoking in the next 30 days; 4) How likely is it that you will quit smoking in the next 30 days.\n\nResponses ranged on 7-point Likert-like scales.\n\nResponses were summed to create a scale for intention to quit (range from 4-28).\n\nHigher values indicate greater intention to quit smoking in the next 30 days.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Non-smokers were not asked the questions about intentions to quit smoking.'}, {'title': 'Intention to purchase cigarettes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}, {'value': '2214', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '1.37', 'groupId': 'BG000'}, {'value': '0.39', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '7.42', 'spread': '2.59', 'groupId': 'BG002'}, {'value': '7.36', 'spread': '2.59', 'groupId': 'BG003'}, {'value': '4.24', 'spread': '4.05', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'We used the Juster scale to measure intention to purchase cigarettes at baseline and at one-month follow-up.\n\nParticipants were asked, "How likely are you to purchase cigarettes in the next 6 months?"\n\nResponses ranged from 0=No chance, almost no chance (1 in 100) to 10=Certain, practically certain (99 in 100).\n\nHigher values reflect higher intention to purchase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'U.S. young adult sexual minority women ages 18-30.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-17', 'size': 236074, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-17T09:51', 'hasProtocol': True}, {'date': '2021-10-11', 'size': 177630, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-15T14:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2021-03-09', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2021-03-20', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-17', 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intention to Quit Smoking', 'timeFrame': 'Day 30', 'description': 'Intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days at baseline and 1 month follow-up.\n\nParticipants were asked to rate 4 statements: I will make an effort to quit smoking in the next 30 days (Unlikely to Likely); I intend to quit smoking in the next 30 days (Strongly disagree to Strongly Agree); I expect to quit smoking in the next 30 days (Definitely false to Definitely true); How likely is it that you will quit smoking in the next 30 days (Unlikely to Likely). Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28).\n\nThis will only be measured among current smokers. Lowest score is 4 and highest mean score is 28. Higher scores indicate increased intention to quit smoking within the next 30 days.'}, {'measure': 'Change in Intention to Purchase Cigarettes', 'timeFrame': 'Day 30', 'description': 'The Juster scale was used to measure intention to purchase cigarettes at baseline and at one-month follow-up.\n\nParticipants were asked, "How likely are you to purchase cigarettes in the next 6 months?" Responses ranged from 0=No chance, almost no chance (1 in 100) to 10=Certain, practically certain (99 in 100).\n\nHigher values reflect higher intention to purchase.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking Behavior']}, 'referencesModule': {'references': [{'pmid': '39543185', 'type': 'DERIVED', 'citation': 'Zulkiewicz BA, Chen JT, Hanby EP, Ramanadhan S, Obedin-Maliver J, Lunn MR, Scout NFN, Gordon B, Applegate J, Machado A, Viswanath K, Potter J, Liu S, Tan ASL. Anti-industry beliefs and attitudes mediate the effect of culturally tailored anti-smoking messages on quit intentions among sexual minority women. Sci Rep. 2024 Nov 15;14(1):28084. doi: 10.1038/s41598-024-78207-7.'}, {'pmid': '38065403', 'type': 'DERIVED', 'citation': 'Tan ASL, Chen JT, Keen R, Scout N, Gordon B, Applegate J, Machado A, Hanby E, Liu S, Zulkiewicz B, Ramanadhan S, Obedin-Maliver J, Lunn MR, Viswanath K, Potter J. Culturally Tailored Anti-Smoking Messages: A Randomized Trial With U.S. Sexual Minority Young Women. Am J Prev Med. 2024 May;66(5):840-849. doi: 10.1016/j.amepre.2023.12.001. Epub 2023 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Project RESIST is an R01 study funded by NCI focused on determining the effects of using culturally tailored inoculation approaches to increase resilience to tobacco marketing influences among young adult sexual minority women ages 18-30 and incorporates critical stakeholder inputs that support later adoption and implementation. The study team is utilizing formative research to design and pre-test anti-smoking messages and two national longitudinal online survey experiments.', 'detailedDescription': 'This study will recruit 2000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1000) and not current smokers (n=1000). The study team will randomly assign participants to a condition in which they will be exposed to either culturally tailored anti-smoking messages or non-tailored. Participants will receive these messages at baseline and 1, 2, and 3 weeks post baseline. They will be asked to complete a follow-up survey one month post baseline. Intentions to quit smoking as well as intention (among current smokers) and intention to purchase cigarettes (among current nonsmokers) will be measured at baseline and one-month post baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Anyone who identifies as a woman, whether they are cisgender or transgender, would meet the gender-based eligibility requirement.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-30\n* Woman\n* Identifies as a sexual minority (any sexual orientation other than heterosexual)\n* Lives in the United States\n* Able to take surveys in English\n\nExclusion Criteria:\n\n* Under 18 or older than 30\n* Men\n* Heterosexual\n* Lives outside the United States\n* Unable to take survey in English'}, 'identificationModule': {'nctId': 'NCT04812795', 'acronym': 'RESIST', 'briefTitle': 'Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches', 'orgStudyIdInfo': {'id': '843579'}, 'secondaryIdInfos': [{'id': 'R01CA237670', 'link': 'https://reporter.nih.gov/quickSearch/R01CA237670', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.', 'interventionNames': ['Other: Culturally tailored anti-smoking messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-culturally tailored (Non-smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.', 'interventionNames': ['Other: Non-culturally tailored interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.\n\nCulturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women.', 'interventionNames': ['Other: Culturally tailored anti-smoking messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-culturally Tailored (Smokers)', 'description': 'The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.\n\nNon-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women.', 'interventionNames': ['Other: Non-culturally tailored interventions']}], 'interventions': [{'name': 'Culturally tailored anti-smoking messages', 'type': 'OTHER', 'description': 'Anti-smoking messages that are culturally tailored for sexual minority women.', 'armGroupLabels': ['Culturally Tailored (Smokers)', 'Culturally tailored (Non-smokers)']}, {'name': 'Non-culturally tailored interventions', 'type': 'OTHER', 'description': 'Anti-smoking messages that are not culturally tailored for sexual minority women.', 'armGroupLabels': ['Non-culturally Tailored (Smokers)', 'Non-culturally tailored (Non-smokers)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Michigan State University', 'class': 'OTHER'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': 'Fenway Community Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andy Tan', 'investigatorAffiliation': 'Abramson Cancer Center at Penn Medicine'}}}}