Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-13 @ 9:24 AM
Study NCT ID:
NCT05089292
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Increasing Breast Cancer Screening in Chinese Immigrants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lina.jandorf@mssm.edu', 'phone': '(212) 659-5506', 'title': 'Lina Jandorf', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study utilized a convenience sample recruited from Chinese community-based organizations located in New York City, which may have contributed to the high percentage of insurance involvement (100%), primary care physician access (100%), and participants living in the United States for more than 20 years. Thus, the generalizability of the findings may be limited, particularly for populations with inadequate insurance coverage.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately post presentation (presentation approximately 1 hour)', 'description': "Post-program survey to access acceptability of adapted narrative education program. Full-scale from 0% to 100%, with a higher percent indicating greater acceptability. An arbitrary cutoff value of 80% acceptance will determine the interventions' acceptability for the study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Engaged in Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Percent of participants who showed up to the Chinese-community-based organizations and would like to participate in the program to assess engagement rate of participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '107 is the number of people in the participating Chinese-community-based organizations.'}, {'type': 'SECONDARY', 'title': 'Change in Breast Cancer Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '4.33', 'spread': '1.229', 'groupId': 'OG000'}]}]}, {'title': '6 months post intervention', 'categories': [{'measurements': [{'value': '4.89', 'spread': '1.108', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months post intervention', 'description': 'Pre- and post-program survey to access change in breast cancer knowledge. Each correct answer counted as 1 point, each incorrect one as 0, and skipped questions as 0. Full scale from 0-6, with a higher score indicates more knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Community Organizations Willing to Host Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}, {'units': 'organizations', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 months', 'description': 'Percentage of Chinese Community-based organizations who were willing to host the program to assess feasibility. Engagement rate of Chinese-community-based organizations was used to access feasibility', 'unitOfMeasure': 'percentage of organizations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'organizations', 'denomUnitsSelected': 'organizations'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Results for Aim 2 of study provided. Gatekeepers and stakeholders were not enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education\n\nNarrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '9.162', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Last Mammogram', 'classes': [{'categories': [{'title': 'Less than 1 year', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': '1-2 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than 2 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-07-22', 'size': 367731, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-07T16:37', 'hasProtocol': True}, {'date': '2022-02-24', 'size': 330792, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-07T16:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre/Post-test design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2021-10-15', 'resultsFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-06', 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire', 'timeFrame': 'immediately post presentation (presentation approximately 1 hour)', 'description': "Post-program survey to access acceptability of adapted narrative education program. Full-scale from 0% to 100%, with a higher percent indicating greater acceptability. An arbitrary cutoff value of 80% acceptance will determine the interventions' acceptability for the study."}, {'measure': 'Number of Participants Who Were Engaged in Program', 'timeFrame': 'Baseline', 'description': 'Percent of participants who showed up to the Chinese-community-based organizations and would like to participate in the program to assess engagement rate of participants'}, {'measure': 'Percentage of Community Organizations Willing to Host Program', 'timeFrame': '7 months', 'description': 'Percentage of Chinese Community-based organizations who were willing to host the program to assess feasibility. Engagement rate of Chinese-community-based organizations was used to access feasibility'}], 'secondaryOutcomes': [{'measure': 'Change in Breast Cancer Knowledge', 'timeFrame': 'baseline and 6 months post intervention', 'description': 'Pre- and post-program survey to access change in breast cancer knowledge. Each correct answer counted as 1 point, each incorrect one as 0, and skipped questions as 0. Full scale from 0-6, with a higher score indicates more knowledge.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer screening', 'Health education', 'Chinese immigrant', 'Health disparities'], 'conditions': ['Screening Mammogram']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.\n\nA total of 156 participants will be recruited during the entire study.\n\nIn Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.\n\nIn Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 40 years of age\n* female\n* born in China\n* read and speak Cantonese, Mandarin, or English\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT05089292', 'briefTitle': 'Increasing Breast Cancer Screening in Chinese Immigrants', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Increasing Breast Cancer Screening in Chinese Immigrants', 'orgStudyIdInfo': {'id': 'STUDY-20-01174'}, 'secondaryIdInfos': [{'id': 'R21CA249261', 'link': 'https://reporter.nih.gov/quickSearch/R21CA249261', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese Immigrants', 'description': 'NYC Chinese immigrants provided with narrative breast health education', 'interventionNames': ['Behavioral: Narrative breast health education']}], 'interventions': [{'name': 'Narrative breast health education', 'type': 'BEHAVIORAL', 'description': 'Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community', 'armGroupLabels': ['Chinese Immigrants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Lina Jandorf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': "Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director', 'investigatorFullName': 'Lina Jandorf', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}