Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT03413605
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2017-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
U01 CRC Project for Vietnamese Americans
Sponsor:
Organization:
Raw JSON
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Ma', 'organization': 'Center for Asian Health, Lewis Katz School of Medicine, TempleUniversity'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'a Multilevel CBPR Intervention', 'description': "The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.", 'otherNumAtRisk': 392, 'deathsNumAtRisk': 392, 'otherNumAffected': 0, 'seriousNumAtRisk': 392, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': "the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups.", 'otherNumAtRisk': 409, 'deathsNumAtRisk': 409, 'otherNumAffected': 0, 'seriousNumAtRisk': 409, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Colorectal Cancer Screening Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'a Multilevel CBPR Intervention', 'description': "The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials."}, {'id': 'OG001', 'title': 'Control Group', 'description': "the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups."}], 'classes': [{'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'percentage of subjects, who received colorectal screening at 12-month Follow Up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'a Multilevel CBPR Intervention', 'description': "The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials."}, {'id': 'FG001', 'title': 'Control Group', 'description': "the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups."}], 'periods': [{'title': 'Overall Study Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Post Intervention Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '12-m Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '409'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '382'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'a Multilevel CBPR Intervention', 'description': "The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials."}, {'id': 'BG001', 'title': 'Control Group', 'description': "the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '50-74 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '646', 'groupId': 'BG002'}]}]}, {'title': '75 or older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '474', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Nativity Status', 'classes': [{'title': 'Foreign Born', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '788', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '399', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}]}, {'title': 'US Born', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '788', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'n=13 participants did not report their nativity status.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-08', 'size': 229377, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-29T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2017-12-11', 'resultsFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-20', 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal Cancer Screening Rate', 'timeFrame': '12 months', 'description': 'percentage of subjects, who received colorectal screening at 12-month Follow Up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest cause of mortality in Vietnamese and Asian Americans. CRC incidence is rising rapidly in Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are more likely to be diagnosed with advanced stage disease, which is highly preventable. Over 85% of Vietnamese Americans in our region (PA, NJ and NYC) are foreign-born with limited English proficiency, have low SES, and live in economically disadvantaged neighborhoods. Many lack knowledge about CRC risks and screening benefits and have limited access to culturally appropriate preventive care. Center for Asian Health, Temple University will be working with Vietnamese CBOs to address their critical health disparities. The investigators will test the hypothesis that the proposed multilevel CRC intervention will yield higher CRC screening rates compared to the control at 12-month follow-up. This project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate intervention to increase CRC screening among underserved Vietnamese. If effective, this innovative CRC intervention can be used as a model program that has potential impact, generalizability and sustainability in Asian American and other underserved ethnic communities.', 'detailedDescription': "Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest cause of mortality in Vietnamese and Asian Americans. CRC incidence is rising rapidly in Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are more likely to be diagnosed with advanced stage disease, which is highly preventable. Over 85% of Vietnamese Americans in our region (PA, NJ, and NYC) are foreign-born with limited English proficiency, have low SES, and live in economically disadvantaged neighborhoods. Many lack knowledge about CRC risks and screening benefits and have limited access to culturally appropriate preventive care. Thus, a multilevel intervention is needed to address the multiple barriers to and determinants of CRC screening in this community. Vietnamese community organizations (VCOs) serve dynamic social functions and represent an important resource for addressing this critical health disparity priority by promoting CRC screening. This project builds on established partnerships and successful work of Center for Asian Health, Temple University with Vietnamese CBOs that address their overwhelming health disparities. CBPR principles will be applied to engage 20 VCOs in all phases of planning, implementing, evaluating, and disseminating a culturally appropriate, theory- and evidence-based multilevel CRC intervention. The proposed intervention will be guided by Social Ecological Model, which addresses sociocultural, behavioral and environmental determinants and intervention strategies at the individual, interpersonal, and community organizational levels. CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) recommend that cancer screenings and other preventive services should be promoted. The standard CPS will be provided to both intervention and control groups, and intervention group will receive CPS + multilevel CRC intervention. Specific Aim 1 is to test the hypothesis that CPS + multilevel CRC intervention will yield higher CRC screening rates compared to CPS control at 12-month follow up; Aim 2 is to examine whether CPS + multilevel CRC intervention (which includes CHW-led group education, automated and interactive text messaging and phone-based peer support) is more effective in changing screening determinants (e.g. KAB, self-efficacy, risk factors, lifestyles, social support, social norms, access barriers) than CPS control condition; and Aim 3 is to assess costs and cost-effectiveness of CPS + multilevel CRC intervention compared to CPS control condition in relation to CRC screening rates in order to inform future dissemination efforts. In sum, this project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate CBPR intervention to increase CRC screening among underserved Vietnamese. If effective, this innovative multilevel CRC intervention can be used as a model program that has potential generalizability and sustainability in Asian American and other underserved ethnic communities to impact preventive behaviors at the population level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. self-identified Vietnamese ethnicity,\n2. age 50 and above,\n3. accessible by cell telephone,\n4. presence in the same geographic study area for a period of one year (to minimize participant attrition);\n5. not enrolled in any CRC intervention (to prevent a potential program impact),\n6. do not have the colorectal polyp, CRC cancer or a family history of CRC (first-degree relative),\n7. non-adherent to CRC screening guidelines (never had CRC screening or are overdue for screening).\n\nExclusion Criteria:\n\n1. enrolled in any CRC intervention (to prevent a potential program impact)\n2. have the colorectal polyp, CRC cancer or a family history of CRC\n3. had CRC screening or adherent to CRC screening guidelines'}, 'identificationModule': {'nctId': 'NCT03413605', 'briefTitle': 'U01 CRC Project for Vietnamese Americans', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans', 'orgStudyIdInfo': {'id': 'U01 Viet CRC'}, 'secondaryIdInfos': [{'id': 'U01MD010627', 'link': 'https://reporter.nih.gov/quickSearch/U01MD010627', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'a multilevel CBPR intervention', 'description': "The intervention will be delivered in group-based education workshop format. The education session is a curriculum-based group education; each group will be having about 15-20 participants. We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education will have two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session is to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.", 'interventionNames': ['Behavioral: A Multilevel CBPR Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': "the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) will be provided to control groups."}], 'interventions': [{'name': 'A Multilevel CBPR Intervention', 'type': 'BEHAVIORAL', 'description': "The intervention will be implemented through a group-based education workshop. The education session is a curriculum-based group education; each group will be having about 15-20 participants. All group education sessions will take place at collaborating Viet community partners sites, and delivered in Vietnamese language, with offering of refreshment. We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education will have two major topics--- (a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion.", 'armGroupLabels': ['a multilevel CBPR intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08401', 'city': 'Atlantic City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vietnamese community center of Atlantic city', 'geoPoint': {'lat': 39.36415, 'lon': -74.42306}}, {'zip': '19147', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bo De Temple', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Grace X Ma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}