Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-07 @ 5:58 PM
Study NCT ID:
NCT02192034
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Navigation to Successful Colorectal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Navigation role in colorectal cancer screening', 'timeFrame': 'Up to 90 days', 'description': 'Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Colon cancer', 'screening', 'navigation'], 'conditions': ['Colorectal Cancer Screening']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer is the second leading cause of death from cancer in the United States. Two major barriers to successful colorectal cancer screening are appointment keeping and proper bowel preparation. The purpose of this study is to test the efficacy of a patient navigation program to increase colorectal cancer screening at Rush University Medical Center. The investigators hypothesize that colorectal cancer screening will be improved for subjects who utilize a patient navigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary care physician\n* Age 50 or greater or 40 or greater with family history of colorectal cancer in first degree relative\n* Average risk for screening as defined as absence of symptomatic abdominal pain and active GI bleeding\n\nExclusion Criteria:\n\n* Age \\> 75 years old\n* Congestive Heart Failure\n* Chronic Obstructive Pulmonary Disease\n* Myocardial Infarction\n* Weight greater than 350 pounds\n* Anticoagulation\n* Inability to speak English'}, 'identificationModule': {'nctId': 'NCT02192034', 'briefTitle': 'Optimizing Navigation to Successful Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Optimizing Navigation to Successful Colorectal Cancer Screening', 'orgStudyIdInfo': {'id': 'ACS255086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation Group', 'description': 'This group will receive standard clinic instructions for the colonoscopy and two additional phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure.', 'interventionNames': ['Behavioral: Navigation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This group will receive only clinic instructions without intervention from the patient navigator.', 'interventionNames': ['Behavioral: Navigation']}], 'interventions': [{'name': 'Navigation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control', 'Navigation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Joshua E Melson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}