Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-26 @ 4:41 AM
Study NCT ID:
NCT00818857
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1072}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2009-01-06', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome.', 'timeFrame': 'End of project, 12/2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer screening', 'screening disparities', 'underserved populations'], 'conditions': ['Preventive Measures']}, 'referencesModule': {'references': [{'pmid': '22046855', 'type': 'DERIVED', 'citation': 'Fiscella K, Humiston S, Hendren S, Winters P, Idris A, Li SX, Ford P, Specht R, Marcus S. A multimodal intervention to promote mammography and colorectal cancer screening in a safety-net practice. J Natl Med Assoc. 2011 Aug;103(8):762-8. doi: 10.1016/s0027-9684(15)30417-x.'}, {'pmid': '20863395', 'type': 'DERIVED', 'citation': 'Fiscella K, Yosha A, Hendren SK, Humiston S, Winters P, Ford P, Loader S, Specht R, Pope S, Adris A, Marcus S. Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice. BMC Health Serv Res. 2010 Sep 23;10:280. doi: 10.1186/1472-6963-10-280.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients', 'detailedDescription': 'This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men age 50-75 yrs.\n* Women age 40-75 yrs\n* One primary care visit in past 2 years.\n\nExclusion Criteria:\n\n* High risk for colorectal or breast cancer.'}, 'identificationModule': {'nctId': 'NCT00818857', 'acronym': 'Get Screened', 'briefTitle': 'Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities', 'orgStudyIdInfo': {'id': 'RSRB 00025557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Early intervention.', 'interventionNames': ['Behavioral: Early Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Delayed intervention', 'interventionNames': ['Behavioral: Delayed intervention']}], 'interventions': [{'name': 'Early Intervention', 'type': 'BEHAVIORAL', 'description': 'At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.', 'armGroupLabels': ['1']}, {'name': 'Delayed intervention', 'type': 'BEHAVIORAL', 'description': 'One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kevin Fiscella, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kevin Fiscella', 'investigatorAffiliation': 'University of Rochester'}}}}