NCT04683731|CompletedResults
Loading search results
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Patient-Centered Outcomes Research Institute
interventional
1,111
1 country
2
Study Start
January 19, 2021
Actual (reported)Primary Completion
May 17, 2023
Actual (reported)Study Completion
July 31, 2023
Actual (reported)Precision prevention holds great promise for colorectal cancer (CRC) screening but has not been adequately explored. A patient's chance of having an advanced colorectal neoplasm (ACN), i.e. a cancer or precancerous polyp in the colon, significantly affects the comparative effectiveness of approved tests. Giving patients a decision aid with information about their risk for ACN, and giving their providers similar information, could help patients and providers decide if colonoscopy or a non-invasive test (such as the fecal immunochemical test) is more appropriate. This could improve decision making and increase uptake of CRC screening, which are the investigative team's long-term goals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2020
Actual (reported)December 24, 2020
Actual (reported)January 19, 2021
Actual (reported)May 17, 2023
Actual (reported)July 31, 2023
Actual (reported)December 13, 2024
Actual (reported)Number of Participants Who Completed Colorectal Cancer Screening
Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
6 months after patient enrollment
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
Decision quality will be assessed using the multi-dimensional measure of informed consent (MMIC), where a high-quality decision is one where the individual has adequate knowledge regarding the available options and undergoes the screening test that he or she has chosen or that fits his or her values ("values concordance"). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 9 correct. Concordance will be measured between the patient's test choice at the post-provider survey and the screening test underwent, if any, within 6 months after patient enrollment.
6 months after participant enrollment
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
6 months after participant enrollment
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Indiana University
Indianapolis, Indiana, 462020, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Schwartz PH, Imperiale TF, Perkins SM, Schmidt KK, Althouse S, Rawl SM. Effect of Personalized Risk Messages on Patient Intent and Decision Making in Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2026 Jul 28:272989X261455045. doi: 10.1177/0272989X261455045. Online ahead of print.
Schwartz PH, Perkins SM, Rawl SM, Schmidt KK, Althouse S, Imperiale TF. Effect of Personalized Risk Messages on Uptake of Colorectal Cancer Screening : A Randomized Controlled Trial. Ann Intern Med. 2025 Oct;178(10):1390-1399. doi: 10.7326/ANNALS-24-03144. Epub 2025 Sep 2.
Peter H. Schwartz, MD, PhD
Indiana University
1,111 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2020
First Posted
December 24, 2020
Study Start
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Patients view decision aid with the personalized message and whose providers receive the personalized message.
The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient.
Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
January 19, 2021
Actual (reported)Primary Completion
May 17, 2023
Actual (reported)Study Completion
July 31, 2023
Actual (reported)Last Updated
December 13, 2024
Results First Posted
December 13, 2024
Record last verified: 2024-11
Yes, researchers who contact the PI with an IRB-approved protocol may be provided de-identified IPD following our institution's data sharing policies.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: