Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 1:22 AM
Study NCT ID:
NCT01629004
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Uptake of Colorectal Cancer Screening in Ontario
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': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of appropriate CRC screening', 'timeFrame': 'Within 6 months of the mailing', 'description': 'The primary outcome will be the uptake of appropriate screening (FOBT testing or if there is a positive family history, of colonoscopy) within 6 months of the mailing as determined by from OHIP and CCO data.'}], 'secondaryOutcomes': [{'measure': 'Uptake of lower gastrointestinal investigations', 'timeFrame': 'Within 12 months of the mailing', 'description': 'The secondary outcome will be the uptake of lower gastrointestinal investigations (colonoscopy for an indication other than family history or colonoscopy done outside of CIRT, flexible sigmoidoscopy, barium enema) within 12 months, respectively, of the mailing as determined by the administrative data (CIRT, OHIP procedure or radiology code).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'screening', 'fecal occult blood testing', 'mailed invitation'], 'conditions': ['Colorectal Disorders']}, 'referencesModule': {'references': [{'pmid': '25195923', 'type': 'DERIVED', 'citation': 'Tinmouth J, Patel J, Austin PC, Baxter NN, Brouwers MC, Earle C, Levitt C, Lu Y, Mackinnon M, Paszat L, Rabeneck L. Increasing participation in colorectal cancer screening: results from a cluster randomized trial of directly mailed gFOBT kits to previous nonresponders. Int J Cancer. 2015 Mar 15;136(6):E697-703. doi: 10.1002/ijc.29191. Epub 2014 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Recipients of a mailed CRC screening invitation through the CCO Invitation Pilot project\n* No OHIP record of completion of FOBT since initial mailing (Non-responders arm only)\n* No OHIP of 'CRC Cancer Screening Exclusion' tracking code since initial mailing (Non-responders arm only)\n* An OHIP record of completion of FOBT 6 months since initial mailing (Recall arm only)\n* Negative result according to LRT or if not in LRT, no record of interval colonoscopy in CIRT or OHIP (Recall arm only)\n\nExclusion Criteria:\n\n* Age greater than 74 years at time of mailing\n* Interval diagnosis of colorectal cancer\n* Interval colonoscopy or flexible sigmoidoscopy\n* Interval departure from Pilot physician's practice\n* Death\n* Presently institutionalized\n* Physician has declined participation in the study\n* Interval record of repeat FOBT (Recall arm only)"}, 'identificationModule': {'nctId': 'NCT01629004', 'briefTitle': 'Increasing Uptake of Colorectal Cancer Screening in Ontario', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Increasing Uptake of Colorectal Cancer Screening in Ontario', 'orgStudyIdInfo': {'id': '308-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-responders', 'description': 'Non-responders to an initial mailed CRC screening invitation from their family physician.\n\nFOBT kit. Mailed invitation.', 'interventionNames': ['Other: FOBT kit', 'Other: Mailed invitation']}, {'type': 'OTHER', 'label': 'Recall patients', 'description': 'Those who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients).\n\nFOBT kit. Mailed invitation.', 'interventionNames': ['Other: FOBT kit', 'Other: Mailed invitation']}], 'interventions': [{'name': 'FOBT kit', 'type': 'OTHER', 'otherNames': ['Mailed FOBT kit'], 'description': 'Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.', 'armGroupLabels': ['Non-responders', 'Recall patients']}, {'name': 'Mailed invitation', 'type': 'OTHER', 'otherNames': ['Mailed invitation alone'], 'description': 'Mailed CRC screening invitation alone on behalf of family physician.', 'armGroupLabels': ['Non-responders', 'Recall patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook HSC', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jill Tinmouth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook HSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}