Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
| Tracking Information | |||||
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| First Received Date ICMJE | April 12, 2010 | ||||
| Last Updated Date | April 4, 2013 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Provider recommendation of CRC screening and patient CRC screening completion rates [ Time Frame: 6 months following patient enrollment in study ] [ Designated as safety issue: No ] Primary outcome measure is provider recommendation of CRC screening and patient CRC screening completion rates at 6 months following patient enrollment in the study. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01103479 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. [ Time Frame: Day of enrollment in study (pre/post measurement) ] [ Designated as safety issue: No ] Secondary outcomes of this study are patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. This will be assessed by a pre/post test interview with the patient before their provider appointment and immediately after they see their provider at the health center. |
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| Original Secondary Outcome Measures ICMJE |
Patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. [ Time Frame: 6 months after enrollment in study ] [ Designated as safety issue: No ] Secondary outcomes of this study are patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. This will be assessed by a pre/post test interview with the patient before their provider appointment and immediately after they see their provider at the health center. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening | ||||
| Official Title ICMJE | Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening | ||||
| Brief Summary | The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved. |
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| Detailed Description | This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening. We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 900 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01103479 | ||||
| Other Study ID Numbers ICMJE | R01-CA140177-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kenzie Cameron, Northwestern University | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | April 2013 | ||||
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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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