Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00265720
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2005-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colorectal Cancer Screening Intervention Trial
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2005-12-13', 'studyFirstSubmitQcDate': '2005-12-13', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact.'}], 'secondaryOutcomes': [{'measure': 'Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions:'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['African Americans', 'Colorectal Cancer Screening', 'Colorectal Cancer', 'Colorectal Cancer and African Americans', 'Cancer Disparities'], 'conditions': ['Colorectal Cancer', 'Colorectal Cancer Screening']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.msm.edu/prc/', 'label': 'Morehouse School of Medicine - Prevention Research Center'}]}, 'descriptionModule': {'briefSummary': 'Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening', 'detailedDescription': 'Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.\n\nThe purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.\n\nParticipants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American\n* Previously not screened for colorectal cancer according to ACS guidelines\n* Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties\n* 50 years of age or older\n\nExclusion Criteria:\n\n* Non-African American\n* Less than 50 years of age\n* Previously screened consistent with ACS guideline'}, 'identificationModule': {'nctId': 'NCT00265720', 'briefTitle': 'Colorectal Cancer Screening Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Morehouse School of Medicine'}, 'officialTitle': 'Research on Community Cancer Control: Study of Colorectal Cancer Screening in the African American Population', 'orgStudyIdInfo': {'id': 'H57/CCH420680-05'}, 'secondaryIdInfos': [{'id': 'H57/CCH420680-05'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Written materials only', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Reduced out-of-pocket expense', 'description': 'Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening', 'interventionNames': ['Other: Reduced out of pocket expense']}, {'type': 'EXPERIMENTAL', 'label': 'One-on-one education', 'description': 'Individual education with a health educator on CRC screening', 'interventionNames': ['Behavioral: one on one education']}, {'type': 'EXPERIMENTAL', 'label': 'Group Education', 'description': 'Education on CRC screening in a small group with a health educator', 'interventionNames': ['Behavioral: Group education']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Written materials only', 'armGroupLabels': ['Control']}, {'name': 'Reduced out of pocket expense', 'type': 'OTHER', 'description': 'Reimbursed up to $500 out of pocket expense for CRC screening', 'armGroupLabels': ['Reduced out-of-pocket expense']}, {'name': 'one on one education', 'type': 'BEHAVIORAL', 'description': 'one on one education with a health educator', 'armGroupLabels': ['One-on-one education']}, {'name': 'Group education', 'type': 'BEHAVIORAL', 'description': 'Education in a small group', 'armGroupLabels': ['Group Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30310-1495', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Daniel Blumenthal, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morehouse School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morehouse School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Principal Investigator: D. Blumenthal', 'oldOrganization': 'Morehouse School of Medicine'}}}}