Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 5:40 PM
Study NCT ID:
NCT04392050
Status:
SUSPENDED
Last Update Posted:
2025-11-28
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Community-Based Educational Intervention to Improve Colorectal Cancer Screening
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'staffing', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful completion of the key contact interviews and focus groups leading to the development of the culturally tailored educational intervention', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study investigates the facilitators and barriers to colorectal cancer screening in underserved populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area. Learning what encourages people and what keeps people from getting colorectal cancer screening may help researchers develop an educational tool for colorectal cancer screening that addresses colorectal cancer knowledge, beliefs, and cultural factors in underserved populations.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. Develop a culturally tailored colorectal cancer education intervention for underserved and under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area.\n\nOUTLINE:\n\nKEY CONTACT INTERVIEWS: Participants participate an interviews over 60 minutes focusing on identifying facilitators and barriers to colorectal cancer screening, essential cultural factors to include in the educational intervention, and insights into the best use of the National Cancer Institute (NCI)'s Screen to Save materials.\n\nFOCUS GROUPS: Participants attend focus groups over 60-90 minutes to examine and define further facilitators and barriers to colorectal cancer, cancer knowledge and beliefs, essential cultural factors to include in the educational intervention, insights into the best use of the NCI's Screen to Save materials, and identification of factors to consider for dissemination and sustainability.\n\nAfter completion of study, participants are followed up for up to 12 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Focus Groups may be facilitated in Chinese (Mandarin), English, or Spanish depending on participant preference\n\nExclusion Criteria:\n\n* • Individuals who do not meet the inclusion criteria\n\n * Individuals who have been diagnosed with colorectal cancer'}, 'identificationModule': {'nctId': 'NCT04392050', 'briefTitle': 'A Community-Based Educational Intervention to Improve Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Community-Based Educational Intervention to Improve Colorectal Cancer Screening', 'orgStudyIdInfo': {'id': '20F.051'}, 'secondaryIdInfos': [{'id': 'JT 14961', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Complete interview'}, {'name': 'Focus Group', 'type': 'OTHER', 'description': 'Attend focus groups'}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ana Marie Lopez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}