Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03979495
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mFOCUS (Multilevel FOllow-up of Cancer Screening)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhaas@mgh.harvard.edu', 'phone': '617-724-1832', 'title': 'Dr. Jennifer Haas', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '240 days', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'standard of care', 'otherNumAtRisk': 2702, 'deathsNumAtRisk': 2702, 'otherNumAffected': 0, 'seriousNumAtRisk': 2702, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IT Platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.', 'otherNumAtRisk': 3254, 'deathsNumAtRisk': 3254, 'otherNumAffected': 0, 'seriousNumAtRisk': 3254, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'IT Platform With Reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.', 'otherNumAtRisk': 2569, 'deathsNumAtRisk': 2569, 'otherNumAffected': 0, 'seriousNumAtRisk': 2569, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'IT Platform and Patient Navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.', 'otherNumAtRisk': 3455, 'deathsNumAtRisk': 3455, 'otherNumAffected': 0, 'seriousNumAtRisk': 3455, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Completion of Follow-up Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '3254', 'groupId': 'OG001'}, {'value': '2569', 'groupId': 'OG002'}, {'value': '3455', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'standard of care'}, {'id': 'OG001', 'title': 'IT Platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'OG002', 'title': 'IT Platform With Reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'OG003', 'title': 'IT Platform and Patient Navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '672', 'groupId': 'OG000'}, {'value': '796', 'groupId': 'OG001'}, {'value': '831', 'groupId': 'OG002'}, {'value': '1062', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days', 'description': 'Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Complete the Required Diagnostic Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '3254', 'groupId': 'OG001'}, {'value': '2569', 'groupId': 'OG002'}, {'value': '3455', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'standard of care'}, {'id': 'OG001', 'title': 'IT Platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'OG002', 'title': 'IT Platform With Reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'OG003', 'title': 'IT Platform and Patient Navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}], 'classes': [{'title': '0-60 days', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}, {'value': '514', 'groupId': 'OG002'}, {'value': '653', 'groupId': 'OG003'}]}]}, {'title': '61-120 days', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '409', 'groupId': 'OG003'}]}]}, {'title': '121-180 days', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}]}]}, {'title': '181-240 days', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}]}, {'title': 'Did not receive follow up', 'categories': [{'measurements': [{'value': '1747', 'groupId': 'OG000'}, {'value': '2084', 'groupId': 'OG001'}, {'value': '1447', 'groupId': 'OG002'}, {'value': '1985', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 240 days', 'description': 'How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Standard care/no changes to usual care'}, {'id': 'FG001', 'title': 'IT Platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'FG002', 'title': 'IT Platform With Reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'FG003', 'title': 'IT Platform and Patient Navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '2702'}, {'groupId': 'FG001', 'numUnits': '11', 'numSubjects': '3254'}, {'groupId': 'FG002', 'numUnits': '11', 'numSubjects': '2569'}, {'groupId': 'FG003', 'numUnits': '11', 'numSubjects': '3455'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '2702'}, {'groupId': 'FG001', 'numUnits': '11', 'numSubjects': '3254'}, {'groupId': 'FG002', 'numUnits': '11', 'numSubjects': '2569'}, {'groupId': 'FG003', 'numUnits': '11', 'numSubjects': '3455'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Primary Care Practices', 'recruitmentDetails': 'Recruitment started in August 2020 and ended in December of 2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'BG000'}, {'value': '3254', 'groupId': 'BG001'}, {'value': '2569', 'groupId': 'BG002'}, {'value': '3455', 'groupId': 'BG003'}, {'value': '11980', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'standard of care'}, {'id': 'BG001', 'title': 'IT Platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'BG002', 'title': 'IT Platform With Reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'BG003', 'title': 'IT Platform and Patient Navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.\n\nmFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1828', 'groupId': 'BG000'}, {'value': '2051', 'groupId': 'BG001'}, {'value': '1557', 'groupId': 'BG002'}, {'value': '2042', 'groupId': 'BG003'}, {'value': '7478', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '874', 'groupId': 'BG000'}, {'value': '1203', 'groupId': 'BG001'}, {'value': '1012', 'groupId': 'BG002'}, {'value': '1413', 'groupId': 'BG003'}, {'value': '4502', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1772', 'groupId': 'BG000'}, {'value': '2139', 'groupId': 'BG001'}, {'value': '1680', 'groupId': 'BG002'}, {'value': '2172', 'groupId': 'BG003'}, {'value': '7763', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '930', 'groupId': 'BG000'}, {'value': '1115', 'groupId': 'BG001'}, {'value': '889', 'groupId': 'BG002'}, {'value': '1283', 'groupId': 'BG003'}, {'value': '4217', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}, {'value': '1095', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2310', 'groupId': 'BG000'}, {'value': '2642', 'groupId': 'BG001'}, {'value': '2137', 'groupId': 'BG002'}, {'value': '2913', 'groupId': 'BG003'}, {'value': '10002', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}, {'value': '883', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '357', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '789', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '2241', 'groupId': 'BG000'}, {'value': '2546', 'groupId': 'BG001'}, {'value': '2051', 'groupId': 'BG002'}, {'value': '2782', 'groupId': 'BG003'}, {'value': '9620', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}, {'value': '1179', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2702', 'groupId': 'BG000'}, {'value': '3254', 'groupId': 'BG001'}, {'value': '2569', 'groupId': 'BG002'}, {'value': '3455', 'groupId': 'BG003'}, {'value': '11980', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-06', 'size': 933974, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-20T09:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The intervention is not masked to the providers or the participants. Randomization status is masked to the participants but not the providers. Masking is not feasible because randomization will take place at the level of the practice and practices will need to be informed about intervention components that will be made available to patients in their practice and the health care team'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "All individuals in this study will receive the current standard of care at Massachusetts General Hospital, Brigham and Women's Hospital, and Dartmouth Hitchcock for the follow-up of abnormal cancer screening tests (Arms 1-4). In addition to this standard of care, we will test 3 additional arms of increasing intensity of intervention: Arm 2-access to an IT platform to facilitate updates to HM modifiers and problem lists for visit-based reminders; Arm 3- the IT platform in addition to automated reminders to patients between visits and the care team; Arm 4-the IT platform, automated reminders, and administrative outreach and navigation to help with scheduling and to address social barriers to care."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2019-05-30', 'resultsFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-04', 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of Follow-up Test', 'timeFrame': '120 days', 'description': 'Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Complete the Required Diagnostic Evaluation', 'timeFrame': 'up to 240 days', 'description': 'How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abnormal Screening Results'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '39424768', 'type': 'DERIVED', 'citation': 'Atlas SJ, Gallagher KL, McGovern SE, Wint AJ, Smith RE, Aman DG, Zhao W, Burdick TE, Orav EJ, Zhou L, Wright A, Tosteson ANA, Haas JS. Patient Perceptions on the Follow-Up of Abnormal Cancer Screening Test Results. J Gen Intern Med. 2025 May;40(6):1280-1287. doi: 10.1007/s11606-024-09128-4. Epub 2024 Oct 18.'}, {'pmid': '37815566', 'type': 'DERIVED', 'citation': 'Atlas SJ, Tosteson ANA, Wright A, Orav EJ, Burdick TE, Zhao W, Hort SJ, Wint AJ, Smith RE, Chang FY, Aman DG, Thillaiyapillai M, Diamond CJ, Zhou L, Haas JS. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1348-1358. doi: 10.1001/jama.2023.18755.'}, {'pmid': '34375748', 'type': 'DERIVED', 'citation': 'Haas JS, Atlas SJ, Wright A, Orav EJ, Aman DG, Breslau ES, Burdick TE, Carpenter E, Chang F, Dang T, Diamond CJ, Feldman S, Harris KA, Hort SJ, Housman ML, Mecker A, Lehman CD, Percac-Lima S, Smith R, Wint AJ, Yang J, Zhou L, Tosteson ANA. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021 Oct;109:106533. doi: 10.1016/j.cct.2021.106533. Epub 2021 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal cancer screening test.', 'detailedDescription': "Standard care consists of well-characterized existing decision support and systems for follow-up in these three participating primary care networks and their affiliated integrated delivery systems (Brigham and Women's Hospital, Massachusetts General Hospital, and Dartmouth Hitchcock Health, the largest health care provider in New Hampshire). The primary outcome will be whether an individual receives follow-up, defined based on the type of screening abnormality and organ type (breast, cervical, lung or colorectal cancer), within 120 days of becoming eligible for mFOCUS. Secondary comparisons will assess multi- and cross-level (individual, team, system) outcomes. The study design will allow us to examine the marginal effectiveness of system, team and individual-level enhancements, and exploratory analyses will address subgroups defined by race/ ethnicity, socioeconomic status and cancer type."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nindividuals who have an abnormal screen that is due for follow-up including:\n\n* Breast: women 40-80 years with an incident (i.e., newly detected) abnormal screening mammogram or digital breast tomosynthesis (DBT) exam.\n* Cervical: women 21-65 years with an incident abnormal screening Pap.\n* Colorectal: adults 40-80 years with an abnormal screen, including incident FOBT (Fecal Occult Blood Test) / FIT (Fecal Immunochemical Test), or prevalent colonoscopy. Because of the long periods of time required for follow-up of colonoscopies, we will look back over a 5-year period and will therefore find prevalent abnormalities that become due for follow-up.\n* Lung: adults 55-80 years, current and former smokers, with an incident abnormal LDCT (Low Dose Computed Topography) result.\n\nExclusion Criteria:\n\nWe will exclude patients who:\n\n* are not English or Spanish-speaking\n* have had prior cancer of the organ for each screening test (i.e., women with prior breast cancer will not be tracked for breast cancer screening abnormalities) as these individuals may have non-standard follow-up care recommendations.'}, 'identificationModule': {'nctId': 'NCT03979495', 'acronym': 'mFOCUS', 'briefTitle': 'mFOCUS (Multilevel FOllow-up of Cancer Screening)', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'mFOCUS (Multilevel FOllow-up of Cancer Screening)', 'orgStudyIdInfo': {'id': '2019P000341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'standard of care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IT platform', 'description': 'Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results', 'interventionNames': ['Other: mFOCUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IT platform with reminders', 'description': 'Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.', 'interventionNames': ['Other: mFOCUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IT platform and patient navigation', 'description': 'the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.', 'interventionNames': ['Other: mFOCUS']}], 'interventions': [{'name': 'mFOCUS', 'type': 'OTHER', 'description': 'To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.', 'armGroupLabels': ['IT platform', 'IT platform and patient navigation', 'IT platform with reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03755', 'city': 'Hanover', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock', 'geoPoint': {'lat': 43.70229, 'lon': -72.28954}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Peter L. Gross MD Chair in Primary Care, Director of Research and Research Education', 'investigatorFullName': 'Jennifer S Haas, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}