Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening
| Tracking Information | |||||
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| First Received Date ICMJE | August 2, 2011 | ||||
| Last Updated Date | April 29, 2013 | ||||
| Start Date ICMJE | August 2011 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Intention to undergo CRC screening in the next six months [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ] [ Designated as safety issue: No ] Multiple choice question assessing subject's interest in getting a colon screening test in the next 6 months (choices: definitely, probably, may or may not, probably not, or definitely not). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01415479 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening | ||||
| Official Title ICMJE | Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening | ||||
| Brief Summary | Fifty thousand people die from colorectal cancer (CRC) every year, making it the second leading cause of death from cancer in the United States. And although there are multiple screening tests that reduce the morbidity and mortality of this disease, less than 60% of eligible individuals are up to date with recommended screening. One of the challenges to improving screening is helping patients understand the range of approved tests, including colonoscopy, sigmoidoscopy, and stool testing (such as fecal immunochemical testing (FIT)). Patients rarely consider all their options, partly due to the limited time they have to learn about them during busy doctor's visits. Computer-based presentations, including decision aids, are a promising tool for improving patient understanding in this and other areas, by giving patients significant amounts of information. But there are important questions about how to design such presentations, including whether they should provide quantitative data about the risks and benefits of screening. Some experts feel that these numbers and graphs are necessary for fully informed decision-making, while others are concerned that they may confuse patients or dissuade them from screening. The investigators have created and pilot tested a computer-based presentation of quantitative information about CRC screening. The investigators found that subjects who viewed the program in a non-healthcare setting exhibited significantly increased interest in screening. In addition, the investigators tested a version of the program that includes a "nudge" towards stool testing with FIT, as a way of encouraging individuals who are confused to undergo some form of screening. In our testing, receiving the nudge was associated with a significant increase in interest in FIT. The investigators now seek to conduct a randomized, controlled study of our computer-based presentation with Clarian patients who are due for CRC screening. All subjects will first view a general video about CRC screening and then will be randomly placed into four groups (using a 2x2 design), to receive quantitative information (or not), and a nudge towards FIT (or not). The results will determine whether a presentation of quantitative information can increase patient understanding, quality of decision-making, and uptake of CRC screening. The results will serve as pilot data for a larger, externally funded study of the effect of individualized ("personalized") quantitative information in this area |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Colonic Neoplasms | ||||
| 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 | Completed | ||||
| Estimated Enrollment ICMJE | 212 | ||||
| Completion Date | March 2013 | ||||
| Primary Completion Date | August 2012 (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 | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01415479 | ||||
| Other Study ID Numbers ICMJE | CCCDA-10-085-01-A, VFR-320-A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Peter Schwartz, Indiana University | ||||
| Study Sponsor ICMJE | Indiana University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Indiana 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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