Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT01072851
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tools for Improving Colorectal Cancer Screening Rates: Multimedia Versus Print
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': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 920}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools', 'timeFrame': '3 months post visit'}], 'secondaryOutcomes': [{'measure': 'Role of race/ethnicity and literacy levels on the comparative effects if the intervention', 'timeFrame': 'At scheduled appointment'}, {'measure': 'Comparative knowledge of colorectal cancer screening by patients who view the print or multi-media educational tools.', 'timeFrame': 'At the scheduled patient visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal cancer screening', 'multimedia education', 'print education', 'culturally competent'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel content to allow valid comparison of format-related effects on knowledge and screening rates.These easy to use tools will provide under served patients at community health centers with clear and consistent messages about colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a doctor.\n\nSpecific Aims\n\n1. To determine if multimedia and print interventions that provide patients with information and motivational messages about CRC screening increase screening rates above usual care.\n2. Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.\n\n 1. Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.\n 2. Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity\n 3. Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.', 'detailedDescription': 'Despite the clear benefits of screening for early detection and prevention of colorectal cancer, as many as half of eligible adults remain unscreened. Poor and under served populations, particularly African American and Latino/Hispanic adults, are at greatest risk for noncompliance with recommended tests. Health education strategies developed to date have led to relatively minimal gains, resulting in little translation to routine clinical practice. This is especially true in more difficult, resource-strained practice settings, such as community health centers.\n\nThe interventions in the proposed study draw on communication science to optimize message design, use communication technology to optimize message delivery and include parallel content in both print and multimedia versions to allow comparison of format-related effects on both knowledge and screening rates.The multimedia and print tools are based on patient education programs that we developed with extensive attention to theory as well as community member input.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50-80 years of age,\n* Registered for an appointment at one of the target clinics,\n* Speaks English or Spanish.\n\nExclusion Criteria:\n\n* Patient has had CRC screening in the past 12 months,\n* Unable to review the study materials because of language, physical condition or literacy.'}, 'identificationModule': {'nctId': 'NCT01072851', 'briefTitle': 'Tools for Improving Colorectal Cancer Screening Rates: Multimedia Versus Print', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Tools for Improving Colorectal Cancer Screening Rates: Multimedia vs Print', 'orgStudyIdInfo': {'id': '0910001-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimedia educational tool', 'description': 'Multimedia education tool - A culturally competent video explaining the importance of and the process of colorectal cancer screening', 'interventionNames': ['Behavioral: Multimedia Education']}, {'type': 'EXPERIMENTAL', 'label': 'Print educational tool', 'description': 'Print media - A culturally competent printed brochure explaining the importance of and the process of colorectal cancer screening', 'interventionNames': ['Behavioral: Print Media']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No intervention', 'description': 'Usual and customary waiting room process - Usual and customary office waiting period with access to standard nationally generated colorectal cancer screening informational material in the waiting room and/or exam room.', 'interventionNames': ['Behavioral: Usual and customary waiting room process']}], 'interventions': [{'name': 'Multimedia Education', 'type': 'BEHAVIORAL', 'otherNames': ['colon cancer', 'communication', 'patient education'], 'description': 'A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.', 'armGroupLabels': ['Multimedia educational tool']}, {'name': 'Print Media', 'type': 'BEHAVIORAL', 'otherNames': ['colon cancer', 'communication', 'education'], 'description': 'Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.', 'armGroupLabels': ['Print educational tool']}, {'name': 'Usual and customary waiting room process', 'type': 'BEHAVIORAL', 'otherNames': ['colon cancer', 'communitcation', 'education'], 'description': 'No specialized educational intervention to promote colorectal cancer screening or to explain the process', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60085', 'city': 'Highland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midlakes Medical Building', 'geoPoint': {'lat': 42.18169, 'lon': -87.80034}}, {'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Chicago Health Center', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}, {'zip': '60085', 'city': 'Waukegan', 'state': 'Illinois', 'country': 'United States', 'facility': 'Belvidere Medical Building', 'geoPoint': {'lat': 42.36363, 'lon': -87.84479}}], 'overallOfficials': [{'name': 'Gregory Makoul, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Francis Hospital & Medical Center, Hartford CT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'Northwestern University Feinberg School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}