Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-02 @ 5:06 AM
Study NCT ID:
NCT06830304
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-17
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopy Appointment Rate', 'timeFrame': 'From enrollment to appointment 90 days'}, {'measure': 'Endoscopy Completion Rate', 'timeFrame': 'From enrollment to appointment Endoscopy Completion 90 days'}, {'measure': 'Time to Endoscopy Completion', 'timeFrame': 'Time interval between endoscopy appointment scheduling and completion of colonoscopy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Screening Compliance']}, 'descriptionModule': {'briefSummary': 'This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. The study population includes community residents aged 50-74 years. Communities in the intervention group will receive multi-level interventions including health education, patient navigation services, and appointment assistance, while communities in the control group will maintain routine screening management. All participants will be followed up for 90 days to track their endoscopy appointment and completion rates. The main research question is:\n\nCan community-based multi-level intervention effectively improve adherence to gastrointestinal cancer screening among community residents?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high-risk individuals of gastrointestinal cancer in 45-74 years old\n\nExclusion Criteria:\n\n* Unable to give consent\n* history of cancer\n* severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease\n* psychiatric illness\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06830304', 'briefTitle': 'A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing University Cancer Hospital'}, 'officialTitle': 'A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ChongqingCancer_GAS20240407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group 1', 'description': 'Communities assigned to this arm will receive intervention including basic health education.', 'interventionNames': ['Behavioral: Health education']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group2', 'description': 'Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services....', 'interventionNames': ['Behavioral: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening']}], 'interventions': [{'name': 'Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening', 'type': 'BEHAVIORAL', 'description': 'This multi-level intervention consists of two major components implemented at community, healthcare provider, and individual levels:\n\nEducation Component:\n\n1. Community level: Public awareness campaigns and educational sessions\n2. Provider level: Training on screening guidelines and communication skills\n3. Individual level: Tailored educational materials and one-on-one counseling\n\nNavigation Component:\n\n1. Patient needs assessment and barrier identification\n2. Personalized navigation services including:\n\nAppointment scheduling assistance Transportation coordination Insurance/financial counseling Reminder calls/messages Social/psychological support', 'armGroupLabels': ['Intervention Group2']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Education Component:\n\n1. Community level: Public awareness campaigns and educational sessions\n2. Provider level: Training on screening guidelines and communication skills', 'armGroupLabels': ['Intervention Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}