Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 8:03 PM
Study NCT ID:
NCT06745895
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Eligible and enrolled patient participants enrolled in the intervention will receive a theory-informed educational booklet about both Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) screening in English or Spanish, access to free stool-based CRC screening, and access to HCV screening. Implementation outcomes, facilitators, and barriers will be examined.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC)', 'timeFrame': 'Up to 12 Months', 'description': 'Screening Uptake will be measured by the number of participants who complete both CRC and HCV screening documented via Electronic Health Record (EHR) at 12 months post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Screening Completion for Hepatitis C Virus (HCV)', 'timeFrame': 'Up to 41 Months', 'description': 'Screening Completion for HCV will be measured by the number of participants who complete HCV Screening at any time during the Study Period.'}, {'measure': 'Screening Completion for Colorectal Cancer (CRC)', 'timeFrame': 'Up to 41 Months', 'description': 'Screening Completion for CRC will be measured by the number of participants who complete CRC Screening at any time during the Study Period.'}, {'measure': 'Screening Test Results for Hepatitis C (HCV)', 'timeFrame': 'Up to 41 Months', 'description': 'Screening Test Results will be measured as abnormal vs normal'}, {'measure': 'Screening Test Results for Colorectal Cancer (CRC)', 'timeFrame': 'Up to 41 Months', 'description': 'Screening Test Results will be measured as abnormal vs normal'}, {'measure': 'Completion of repeat CRC Screening', 'timeFrame': 'Up to 41 Months', 'description': 'Completion of any repeat CRC Screening will be measured by the number of participants who repeat CRC Screening during the Study interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening', 'HCV Screening', 'CRC Screening', 'Colorectal Cancer (CRC)', 'Hepatitis C Virus (HCV)'], 'conditions': ['Colorectal Cancer Screening', 'Hepatitis C Virus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.moffitt.org/clinical-trials-research/clinical-trials/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This innovative Multilevel Action Toward Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) Education and Screening (MATCHES) intervention aims to promote concurrent HCV and CRC screening among FQHC patients ages 45-75.', 'detailedDescription': 'While this is a multi-level intervention study, only information related to the patient-level intervention is being reported for the purposes ClinicalTrials.gov.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be receiving care at one of the participating FQHC clinics.\n* Participants must be 45-75 years of age.\n* Participants must not be up to date with Colorectal Cancer (CRC) screening recommendations such as no colonoscopy in the past 10 years, occult blood test in the past 12 months.\n* Participants must never have had Hepatitis C Virus (HCV) antibody screening.\n* Participants must be able to read, write, and understand English or Spanish.\n* Participants must have no personal history of CRC or current presumptive CRC symptoms such as unresolved rectal bleeding or abdominal pain/bloating.\n* Participants must be at average risk for CRC (no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC).\n* Participants must be asymptomatic for HCV.\n* Participants receiving intervention materials must be able and willing to complete surveys and receive the patient level intervention.\n* Participants completing qualitative interviews must be willing to complete a remote interview via phone or teleconference software such as ZOOM.\n* Participants completing qualitative interviews must be willing to be audio recorded.\n* Participants recruited for qualitative interviews only (did not receive MATCHES intervention materials) must have a clinic visit within prior two months.\n* All Participants must be able to provide informed consent.\n\nExclusion Criteria:\n\n* Participants that do not meet all Inclusion Eligibility requirements will be excluded.'}, 'identificationModule': {'nctId': 'NCT06745895', 'acronym': 'MATCHES', 'briefTitle': 'Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)', 'orgStudyIdInfo': {'id': 'MCC-23232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)', 'description': 'The MATCHES intervention includes three patient-level intervention strategies that will be rolled out in two waves. Patient-level strategies are: 1) a combined education booklet with information about CRC/CRC screening and HCV infections/liver cancer/HCV screening in English or Spanish, 2) access to free stool-based CRC screening, and 3) access to free HCV antibody testing.', 'interventionNames': ['Behavioral: MATCHES']}], 'interventions': [{'name': 'MATCHES', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to complete a survey with specific topics including Hepatitis C (HCV) and Colorectal (CRC) knowledge and health beliefs, screening intentions and demographic characteristics.\n\nParticipants will be provided with education intervention materials (for example, a booklet) either in-person or via mail, access to free stool-based CRC screening, and access to free HCV screening.\n\nApproximately 1-2 weeks after receiving the education materials, participants will be asked to complete a post-intervention survey about the same specific topics (for example, HCV and CRC knowledge, HCV and CRC health beliefs, HCV and CRC screening intentions, healthcare experiences, perceptions of the educational materials) over the phone with a trained study staff.\n\nParticipants with a positive HCV screening and/or CRC screening result will be navigated to follow-up care as needed.', 'armGroupLabels': ['Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carol Boxtha', 'role': 'CONTACT', 'email': 'Carol.Boxtha@Moffitt.org', 'phone': '813-745-8963'}, {'name': 'Christy Shannon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clement K Gwede, PhD, MPH, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susan T Vadaparampil, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Carol Boxtha', 'role': 'CONTACT', 'email': 'Carol.Boxtha@Moffitt.org', 'phone': '813-745-8963'}, {'name': 'Shannon Christy, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Shannon Christy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Clement K. Gwede, PhD, MPH, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Biomedical Research Program - Bankhead Coley', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}