Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04848051
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of participants who completed their colorectal cancer screening', 'timeFrame': '18 months', 'description': 'The total number of participants that completed their colorectal cancer screening will be measured between the different arms'}], 'secondaryOutcomes': [{'measure': 'Time to engagement', 'timeFrame': '18 months', 'description': 'The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms'}, {'measure': 'Screening outcomes: results of screening', 'timeFrame': '18 months', 'description': 'Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.'}, {'measure': 'Screening outcomes: follow up', 'timeFrame': '18 months', 'description': 'Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.'}, {'measure': 'Screening outcomes: biopsy results', 'timeFrame': '18 months', 'description': 'Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.'}, {'measure': 'Screening outcomes: diagnostic results', 'timeFrame': '18 months', 'description': 'Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Screening'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.', 'detailedDescription': 'This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be 50-74 years of old at the time of enrollment\n* have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020\n\nExclusion Criteria:\n\n• Documented history of colorectal cancer'}, 'identificationModule': {'nctId': 'NCT04848051', 'briefTitle': 'Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations', 'orgStudyIdInfo': {'id': '2000030006'}, 'secondaryIdInfos': [{'id': '2P30CA016359-39', 'link': 'https://reporter.nih.gov/quickSearch/2P30CA016359-39', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRC screening reminder', 'description': 'Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening', 'interventionNames': ['Behavioral: CRC screening reminder']}, {'type': 'EXPERIMENTAL', 'label': 'CRC Reminder & Short message', 'description': 'Participants randomized to the CRC Reminder \\& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening', 'interventionNames': ['Behavioral: CRC Reminder & Short message']}, {'type': 'EXPERIMENTAL', 'label': 'CRC Reminder and Navigation Program', 'description': 'Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance', 'interventionNames': ['Behavioral: CRC Reminder and Navigation Program']}, {'type': 'EXPERIMENTAL', 'label': 'CRC Reminder & CRC education', 'description': 'Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online', 'interventionNames': ['Behavioral: CRC Reminder & CRC education']}], 'interventions': [{'name': 'CRC screening reminder', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening', 'armGroupLabels': ['CRC screening reminder']}, {'name': 'CRC Reminder & Short message', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the CRC Reminder \\& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening', 'armGroupLabels': ['CRC Reminder & Short message']}, {'name': 'CRC Reminder and Navigation Program', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance', 'armGroupLabels': ['CRC Reminder and Navigation Program']}, {'name': 'CRC Reminder & CRC education', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online', 'armGroupLabels': ['CRC Reminder & CRC education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cornell Scott Hill Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Beth Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}