Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening
NCT ID: NCT01415479
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2011-08-31
2013-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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Quantitative
Subjects view:
1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Quantitative
Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Default
Subjects view:
1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
2. Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT).
Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Default
Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the "Default" intervention since it attempts to shift the "default" choice from "no screening" to FIT.
Quantitative + Default
Subjects view:
1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
3. Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT).
Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Quantitative
Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Default
Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the "Default" intervention since it attempts to shift the "default" choice from "no screening" to FIT.
Control
Subjects view a computer-based presentation regarding colorectal cancer (CRC) and available screening tests for CRC, primarily a video produced by the American Cancer Society.
Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Interventions
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Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Quantitative
Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Default
Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the "Default" intervention since it attempts to shift the "default" choice from "no screening" to FIT.
Eligibility Criteria
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Inclusion Criteria
* No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years or fecal occult blood testing (including FIT) in last 1 year, and
* Upcoming appointment with primary care physician at three primary care sites of IU Health (previously sites of the Methodist Medical Group (MMG)): Internal Medicine and Pediatrics Fishers, Family \& Internal Medicine South, or Family \& Internal Medicine East Washington.
Exclusion Criteria
* Diagnosis or medical history conferring elevated risk for CRC including previous polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC, or
* Inability to speak English and to fill out a questionnaire written in English.
50 Years
75 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Peter Schwartz
Assistant Professor of Medicine
Principal Investigators
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Peter H. Schwartz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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IU Health
Indianapolis, Indiana, United States
Countries
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References
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Rager JB, Althouse S, Perkins SM, Schmidt KK, Schwartz PH. Measuring the Impact of Quantitative Information on Patient Understanding: Approaches for Assessing the Adequacy of Patient Knowledge about Colorectal Cancer Screening. MDM Policy Pract. 2022 Nov 25;7(2):23814683221140122. doi: 10.1177/23814683221140122. eCollection 2022 Jul-Dec.
Schwartz PH, Perkins SM, Schmidt KK, Muriello PF, Althouse S, Rawl SM. Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. Med Decis Making. 2017 Aug;37(6):688-702. doi: 10.1177/0272989X17698678. Epub 2017 Apr 11.
Other Identifiers
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VFR-320-A
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CCCDA-10-085-01-A
Identifier Type: -
Identifier Source: org_study_id