Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT00558233
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2007-11-13', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receipt of colorectal cancer screening', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': "Change in participants' readiness to be screened (Stage of Change)", 'timeFrame': 'Day 1'}, {'measure': 'Self-reported intent to discuss colorectal cancer screening with healthcare provider', 'timeFrame': 'Day 1'}, {'measure': 'Provider ordering a colorectal cancer screening test', 'timeFrame': 'Day 1'}, {'measure': 'Participant completion of computer program without assistance', 'timeFrame': 'Day 1'}, {'measure': 'Participant acceptance of computer program', 'timeFrame': 'Day 1'}, {'measure': 'Number of polyps and cancers found by screening tests performed', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Screening', 'Health literacy', 'Patient education', 'Computer assisted instruction'], 'conditions': ['Colorectal Cancer', 'Health Literacy']}, 'referencesModule': {'references': [{'pmid': '21565651', 'type': 'DERIVED', 'citation': 'Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.', 'detailedDescription': 'Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Scheduled to see an internal medicine provider\n* No recent colorectal cancer screening\n\nExclusion Criteria:\n\n* Personal history of colorectal cancer\n* Family history of colorectal cancer\n* Blood seen in stools within last month\n* Obvious cognitive or physical impairment that would prevent participation'}, 'identificationModule': {'nctId': 'NCT00558233', 'acronym': 'InfoPC', 'briefTitle': 'Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Overcoming Literacy Barriers in Colorectal Cancer Screening', 'orgStudyIdInfo': {'id': 'CCCDA-05-162-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: CHOICE decision aid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Behavioral: YourMeds patient education program']}], 'interventions': [{'name': 'CHOICE decision aid', 'type': 'BEHAVIORAL', 'otherNames': ['CHOICE'], 'description': 'computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit', 'armGroupLabels': ['Intervention group']}, {'name': 'YourMeds patient education program', 'type': 'BEHAVIORAL', 'otherNames': ['YourMeds'], 'description': 'computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center; Downtown Health Plaza', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David P Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}