Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities (Get Screened)
This study is enrolling participants by invitation only.
Sponsor:
University of Rochester
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00818857
First received: January 6, 2009
Last updated: November 9, 2011
Last verified: January 2009
| Tracking Information | |||||
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| First Received Date ICMJE | January 6, 2009 | ||||
| Last Updated Date | November 9, 2011 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: End of project, 12/2011 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00818857 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities | ||||
| Official Title ICMJE | Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities | ||||
| Brief Summary | The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Preventive Measures | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2000 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00818857 | ||||
| Other Study ID Numbers ICMJE | RSRB 00025557 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kevin Fiscella, MD MPH, Associate Professor of Family Medicine, University of Rochester Medical Center | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | American Cancer Society, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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