Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 12:56 AM
Study NCT ID:
NCT04980157
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': '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': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hepatitis C Virus (HCV) knowledge', 'timeFrame': 'Day 1 & Day 7', 'description': 'Participants will be interviewed regarding their HCV knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials.'}, {'measure': 'Change in Colorectal Cancer (CRC) knowledge', 'timeFrame': 'Day 1 & Day 7', 'description': 'Participants will be interviewed regarding their CRC knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials.'}, {'measure': 'Hepatitis C Virus Screening Status', 'timeFrame': 'at 6 months', 'description': "Data about participants' HCV screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials."}, {'measure': 'Colorectal Cancer Screening Status', 'timeFrame': 'at 6 months', 'description': "Data about participants' CRC screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV Screening', 'CRC Screening'], 'conditions': ['Hepatitis C Virus Infection', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '56 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients born between 1945-1965 up to age 75 who have clinic visits at a partnering federally qualified health center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born between 1945 and 1965 and up to age 75\n* No personal history of colorectal cancer (CRC) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating)\n* No personal history of hepatitis C virus (HCV) or liver cancer\n* Able to read, write, speak, and understand English or Spanish\n* Not currently enrolled in another CRC screening or a HCV screening study\n* At average risk for CRC (that is, no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC)\n* Not currently up-to date with CRC screenings\n* Not having previously completed HCV screening\n* Able and willing to complete a phone interview\n* Able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04980157', 'briefTitle': 'CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'CARES-HCV: Promoting Concurrent Hepatitis C Virus Screening and Colorectal Cancer Screening Uptake Among Diverse Baby Boomers', 'orgStudyIdInfo': {'id': 'MCC-20601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Patients born between 1945-1965 who have clinic visits at a partnering federally qualified health center.', 'interventionNames': ['Behavioral: CARES-HCV']}], 'interventions': [{'name': 'CARES-HCV', 'type': 'BEHAVIORAL', 'description': 'CARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Shannon M Christy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Clement K Gwede, PhD, MPH, RN, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}