Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT01830933
Status:
COMPLETED
Last Update Posted:
2014-08-19
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breast Cancer Risk Reduction: A Patient Doctor Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'celia.kaplan@ucsf.edu', 'phone': '415-502-5601', 'title': 'Celia P. Kaplan, Professor', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.', 'otherNumAtRisk': 655, 'otherNumAffected': 0, 'seriousNumAtRisk': 655, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.', 'otherNumAtRisk': 580, 'otherNumAffected': 0, 'seriousNumAtRisk': 580, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knowledge of Breast Cancer Risk Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'OG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '24.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one week post-initial visit (approximately one week)', 'description': 'Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Correct Perception of Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'OG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}]}]}, {'title': 'Final (one week post-intial visit)', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, one week post-initial visit (approximately one week)', 'description': 'This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had a Discussion of Breast Cancer Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'OG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one week post-initial visit (approximately one week)', 'description': 'Self-reported discussion of breast cancer risk with physicians.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Reported Discussion of Mammography Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'OG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 14 months', 'description': 'Self reported discussion of mammography with physician.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'FG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '823'}, {'groupId': 'FG001', 'numSubjects': '812'}]}, {'type': 'Completed Meet-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '675'}, {'groupId': 'FG001', 'numSubjects': '603'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '655'}, {'groupId': 'FG001', 'numSubjects': '580'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '232'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '1235', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.'}, {'id': 'BG001', 'title': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.\n\nBreastCARE : The physician will receive a physician report that contains information similar to the patient report.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}, {'title': '51-65 years', 'categories': [{'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '655', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '1235', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Latina White', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}, {'title': 'Latina', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}, {'title': 'Black/ African American', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Native American or Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '655', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '1235', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of participants who completed follow-up.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-15', 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of Breast Cancer Risk Factors', 'timeFrame': 'one week post-initial visit (approximately one week)', 'description': 'Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O'}, {'measure': 'Percentage of Participants With Correct Perception of Risk', 'timeFrame': 'baseline, one week post-initial visit (approximately one week)', 'description': 'This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.'}, {'measure': 'Percentage of Participants Who Had a Discussion of Breast Cancer Risk', 'timeFrame': 'one week post-initial visit (approximately one week)', 'description': 'Self-reported discussion of breast cancer risk with physicians.'}, {'measure': 'Percentage of Participants Who Reported Discussion of Mammography Screening', 'timeFrame': 'up to 14 months', 'description': 'Self reported discussion of mammography with physician.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer concern, breast cancer risk perception, breast cancer risk'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '26476466', 'type': 'DERIVED', 'citation': 'Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21.'}]}, 'descriptionModule': {'briefSummary': "The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient component:\n\n * Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period\n * Between the ages of 40 and 74\n * Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White\n * Have no history of breast cancer are eligible to participate.\n2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF\n\nExclusion Criteria:\n\n1. Patient component: Women whose physicians object to their participation in the study\n2. Physician component: No exclusion criteria for physicians'}, 'identificationModule': {'nctId': 'NCT01830933', 'acronym': 'BreastCARE', 'briefTitle': 'Breast Cancer Risk Reduction: A Patient Doctor Intervention', 'nctIdAliases': ['NCT01836250'], 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Breast Cancer Risk Reduction: A Patient Doctor Intervention', 'orgStudyIdInfo': {'id': '150B-0158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BreastCARE Intervention', 'description': 'Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment.\n\nIntervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor.', 'interventionNames': ['Other: BreastCARE']}, {'type': 'NO_INTERVENTION', 'label': 'BreastCARE Comparison', 'description': 'Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups.\n\nComparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization.'}], 'interventions': [{'name': 'BreastCARE', 'type': 'OTHER', 'description': "Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.", 'armGroupLabels': ['BreastCARE Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital (SFGH)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco Mt. Zion campus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Celia P Kaplan, DrPH, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}, {'name': 'California Breast Cancer Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}