Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT04464668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2020-07-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Colorectal Cancer Screening Rates - Initial FIT', 'timeFrame': 'Years 1-5', 'description': 'Percentage of patients who complete initial Fecal Immunochemical Test (FIT)'}, {'measure': 'Change in Colorectal Cancer Screening Rates - Repeat FIT', 'timeFrame': 'Years 1-5', 'description': 'Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)'}], 'secondaryOutcomes': [{'measure': 'Differences in Screening Rates', 'timeFrame': 'Years 2-5', 'description': 'Screening rate differences to determine how variables such as clinic setting (rural vs urban), population characteristics such as nativity (foreign born status), language preference, education, income, health insurance, etc. differentially impact annual clinic Colorectal Cancer (CRC) screening rates.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fecal Immunochemical Test', 'F.I.T.'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '39070625', 'type': 'DERIVED', 'citation': 'Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Joshua A, Pollard J, Friedman M, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center clinics: A stepped-wedge, multilevel intervention trial. Res Sq [Preprint]. 2024 Jul 18:rs.3.rs-4558718. doi: 10.21203/rs.3.rs-4558718/v1.'}], 'seeAlsoLinks': [{'url': 'https://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.', 'detailedDescription': 'This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Staff and providers working in a clinic within one of the two participating systems\n* Involved in adult patient care\n\nExclusion Criteria:\n\n* Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening'}, 'identificationModule': {'nctId': 'NCT04464668', 'acronym': 'CARES-REACH', 'briefTitle': 'Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health', 'orgStudyIdInfo': {'id': 'MCC-20560'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Wave 1 Only: Clinics using CARES Intervention', 'description': 'Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education \\& Screening (CARES) intervention.', 'interventionNames': ['Behavioral: Provider Tools', 'Behavioral: Provider surveys']}, {'label': 'Wave 1 Only: Control Clinics', 'description': 'Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics.'}, {'label': 'All Clinics', 'description': 'For Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2.', 'interventionNames': ['Behavioral: Provider Tools', 'Behavioral: Provider surveys']}], 'interventions': [{'name': 'Provider Tools', 'type': 'BEHAVIORAL', 'description': 'Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.', 'armGroupLabels': ['All Clinics', 'Wave 1 Only: Clinics using CARES Intervention']}, {'name': 'Provider surveys', 'type': 'BEHAVIORAL', 'description': 'Remote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)', 'armGroupLabels': ['All Clinics', 'Wave 1 Only: Clinics using CARES Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Clement K Gwede, PhD MPH RN FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}