Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-23 @ 3:02 PM
Study NCT ID:
NCT02964234
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2016-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Empowering Latinas to Obtain Breast Cancer Screenings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ymolin2@uic.edu', 'phone': '312-355-2679', 'title': 'Dr. Yamile Molina', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There are several limitations to this study, including a small sample, use of non-probability based sampling strategies, and non-randomization.'}}, 'adverseEventsModule': {'timeFrame': 'Data were collected for up to 6 months per participant.', 'description': 'We used standard definitions of adverse and serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Have Obtained Breast Cancer Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks'}, {'id': 'OG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.59', 'ciLowerLimit': '2.01', 'ciUpperLimit': '56.31', 'pValueComment': 'We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.', 'groupDescription': 'We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis used - only participants who were retained until 6 month follow-up.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Psychosocial Facilitators of Screening Survey Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks'}, {'id': 'OG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'}], 'classes': [{'title': 'Knowledge', 'categories': [{'measurements': [{'value': '0.98', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Cultural Beliefs', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '3.13', 'groupId': 'OG001'}]}]}, {'title': 'Self-Efficacy', 'categories': [{'measurements': [{'value': '1.02', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '5.99', 'groupId': 'OG001'}]}]}, {'title': 'Social Norms', 'categories': [{'measurements': [{'value': '0.25', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Supportive Network size', 'categories': [{'measurements': [{'value': '1.38', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.04', 'groupDescription': 'Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Total scores/ranges are used. No subscales used. Knowledge - 5 items (Williams et al., 2011). Range for the change scores (baseline to 6-months) is -5 to 5. Higher scores represent a better outcome.\n\nCultural beliefs - Ferrans cultural beliefs scale (Ferrans et al., 2007). Range for the change scores (baseline to 6-months) is -17 to 17. Higher scores represent a worse outcome.\n\nBreast cancer-specific self-efficacy - Mammography-Specific Self-Efficacy Scale (Champion, Skinner, \\& Menon, 2005). Range for the change scores (baseline to 6-months) is -26 to 26. Higher scores represent a better outcome.\n\nPositive breast cancer screening norms - 6 items ( Molina et al., 2015). Range for the change scores (baseline to 6-months) is -12 to 12. Higher scores represent a better outcome.\n\nBreast cancer supportive social network size questions comprised an 8-item version of Berkman-Syme index. Range for the change scores (baseline to 6-months) is -25 to 25. Higher scores represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a complete case analysis for outcome data, with all available data being used for participants who completed the 6-month follow-up.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks'}, {'id': 'OG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.27', 'spread': '6.17', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '12.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.15', 'ciLowerLimit': '2.82', 'ciUpperLimit': '13.32', 'pValueComment': 'Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.', 'groupDescription': "We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).", 'statisticalMethod': 'Ordinal regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.', 'unitOfMeasure': 'family/friends engaged', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis used, wherein we focus on participants who completed the 6-month follow-up surveys.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks'}, {'id': 'FG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Empowerment', 'description': 'Behavior: Empowerment\n\nEmpowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks'}, {'id': 'BG001', 'title': 'Education', 'description': 'Behavior: Education\n\nEducation: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.05', 'spread': '6.29', 'groupId': 'BG000'}, {'value': '61.28', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '61.16', 'spread': '6.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insurance', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mammogram 4+ years ago', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mammography intention within next year', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-03', 'size': 480603, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-25T20:30', 'hasProtocol': True}, {'date': '2017-11-07', 'size': 216867, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-04-25T20:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2016-11-11', 'resultsFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2016-11-11', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-18', 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Psychosocial Facilitators of Screening Survey Measures', 'timeFrame': 'Baseline and 6 months', 'description': 'Total scores/ranges are used. No subscales used. Knowledge - 5 items (Williams et al., 2011). Range for the change scores (baseline to 6-months) is -5 to 5. Higher scores represent a better outcome.\n\nCultural beliefs - Ferrans cultural beliefs scale (Ferrans et al., 2007). Range for the change scores (baseline to 6-months) is -17 to 17. Higher scores represent a worse outcome.\n\nBreast cancer-specific self-efficacy - Mammography-Specific Self-Efficacy Scale (Champion, Skinner, \\& Menon, 2005). Range for the change scores (baseline to 6-months) is -26 to 26. Higher scores represent a better outcome.\n\nPositive breast cancer screening norms - 6 items ( Molina et al., 2015). Range for the change scores (baseline to 6-months) is -12 to 12. Higher scores represent a better outcome.\n\nBreast cancer supportive social network size questions comprised an 8-item version of Berkman-Syme index. Range for the change scores (baseline to 6-months) is -25 to 25. Higher scores represent a better outcome.'}, {'measure': 'Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.', 'timeFrame': '6 months', 'description': 'This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Have Obtained Breast Cancer Screening', 'timeFrame': '6 months', 'description': 'Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mammography Screening', 'Latinas', 'Breast cancer disparities'], 'conditions': ['Breastcancer', 'Breast Diseases']}, 'descriptionModule': {'briefSummary': "The participatory-based project will quantify the 'added benefit' of an empowerment intervention relative to an education intervention for 150 Latinas on the following outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial facilitators (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health messages throughout their social network. The empowerment intervention will train Latinas in how to discuss breast health with their family and friends and volunteer in local breast health promotion programs. Academic, clinician, and community partners will work together throughout intervention development and evaluation.", 'detailedDescription': "Latinas suffer disproportionately from breast cancer relative to non-Latina Whites (NLWs), including late stage detection. While there have been controversies in breast cancer screening, non-adherence to guideline-concordant screening continues to be a major modifiable determinant of breast cancer outcome disparities. Thus, increasing participation in breast cancer screening among Latinas, especially care that corresponds with clinical and academic guidelines, is a public health priority. Participatory approaches are popular methods to improve screening within this group and have included approaches that 1) deliver education to non-adherent Latinas and 2) train community health advocates (community health workers, breast cancer survivors) to engage in breast health promotion. The second approach (empowerment interventions) concerns training participants to engage in social outreach (e.g., having conversations with family and friends about breast health) and volunteering (e.g., helping in health fairs, engaging in civic campaigns about breast cancer programs). Patient activation and volunteerism literature suggest that empowerment interventions may have 'added value' for participants themselves over delivering education in terms of preventive health psychosocial factors and practices. Relative to education interventions, empowerment interventions may also affect women's networks, as they may be more likely to disseminate evidence-based breast health promotion among their family and friends. To date, little research has compared interventions' effects on individual-level outcomes or used formal social network analysis to examine network effects. The proposed work adds to the literature through empirically comparing two approaches (education versus empowerment) on three sets of outcomes: 1) women's own screening, 2) women's own self-efficacy, norms, support, knowledge; and 3) women's networks (measured by egocentric analysis). I will lead this work and will benefit from the collective expertise and resources of my mentors (Drs. Ferrans, Mermelstein, Geller) and collaborators (Dr. Schneider, The Resurrection Project, Metropolitan Chicago Breast Cancer Task Force, Sinai Urban Health Institute, University of Illinois Cancer Center). Aim 1 intervention development will be accomplished through continuous stakeholder engagement and specifically through meetings and focus groups with a bilingual, bicultural community advisory engagement board (CEAB), UICC radiologists and target participants (non-adherent Latinas). We have already begun this process and are obtaining formative data. After we develop intervention materials, a pilot trial will be conducted with an area-level treatment control group design in Chicago. Participants will be 150 Latinas with no history of health volunteerism, residence in one of two targeted areas, and non-adherence to US Preventive Services Task Force screening guidelines. Aim 1 intervention evaluation will involve an analysis to compare differences in receipt of a medical record-confirmed screening within six months of participating in the study. Aim 2 will be an analysis to compare interventions' effects on self-efficacy, norms, support, knowledge across three time points - pre-intervention, immediately post-intervention, and six months post-intervention. Aim 3 will be a social network analysis, specifically egocentric, to compare interventions' effects on breast health, network size, and network density as well as will number of peers referred to the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '52 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 52-75 years old;\n* Identification as Latina/Hispanic/Chicana female;\n* Residence in Pilsen, Little Village, East Side or South Chicago;\n* No history of health volunteerism;\n* No history of breast cancer; and\n* Lack of a mammogram within the last two years\n\nExclusion Criteria:\n\n* Not meeting all inclusion criteria;\n* Women will be excluded if they participated in formative focus groups'}, 'identificationModule': {'nctId': 'NCT02964234', 'briefTitle': 'Empowering Latinas to Obtain Breast Cancer Screenings', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Empowering Latinas to Obtain Breast Cancer Screenings', 'orgStudyIdInfo': {'id': '2015-1246'}, 'secondaryIdInfos': [{'id': 'K01CA193918', 'link': 'https://reporter.nih.gov/quickSearch/K01CA193918', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empowerment', 'description': 'Behavior: Empowerment', 'interventionNames': ['Behavioral: Empowerment']}, {'type': 'EXPERIMENTAL', 'label': 'Education', 'description': 'Behavior: Education', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Empowerment', 'type': 'BEHAVIORAL', 'description': 'Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', 'armGroupLabels': ['Empowerment']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Resurrection Project', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60617', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Juan Diego Centro Comunitario', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Yamile Molina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will become available 6 months after publication of the primary outcome papers.', 'ipdSharing': 'YES', 'description': 'After major study findings have been accepted for publication, Dr. Molina will develop an anonymized data set (i.e., no personally identifiable information) available to qualified scientists upon request. Data will only be made available to scientists who complete a data-sharing agreement that indicates: 1) commitment to using the data only for research purposes and not to identify any individual participant; 2) commitment to securing data using appropriate computer technology; and 3) commitment to destroying or returning the data after analyses are completed.', 'accessCriteria': 'The study protocol will be shared upon reasonable request by interested researchers. IRB approval will be required before data are released.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Resurrection Project', 'class': 'OTHER'}, {'name': 'Juan Diego Centro Comunitario', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yamile Molina', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}