Status:
COMPLETED
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Cancer Screening Tests
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
The research team has developed and pilot tested a decision aid and provider message that discloses the patient's current risk of ACN, based on a prediction rule developed and validated by Dr. Thomas ...
Eligibility Criteria
Inclusion
- PATIENTS will be eligible if they are:
- age 50 - 75 years
- have not had a colonoscopy performed in the last 10 years, sigmoidoscopy in the last 5 years, fecal occult blood testing (FOBT or FIT) in the last year, or Cologuard in the last 3 years
- have not had a colonoscopy since turning 50 years old
- have a scheduled appointment with a provider who agreed to participate in the study
- PROVIDERS will be eligible if they are:
- a physician (MD or DO), nurse practitioner (NP), or physicians assistant (PA) practicing at a partner research site
Exclusion
- PATIENTS will be excluded if they are:
- undergoing workup for symptoms consistent with CRC, such as unexplained weight loss, change in bowel habit, or rectal bleeding
- have a diagnosis or medical history conferring elevated risk for CRC including a previous adenomatous polyp or CRC, inflammatory bowel disease, high-risk syndromes, or a significant family history of CRC (two or more first degree relatives (FDR) with CRC or one FDR with a CRC diagnosis prior to age 60)
- are unable to speak and read English
- previously participated in any research projects regarding colorectal cancer screening or colonoscopy including, but not limited to the investigators' previous studies
- members of the study team will not be participating in the study; therefore, patients who have a scheduled appointment with any member of the study team will not be eligible.
- PROVIDERS will be excluded if they:
- do not have patients between 50 - 75 years old.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
1111 Patients enrolled
Trial Details
Trial ID
NCT04683731
Start Date
January 19 2021
End Date
July 31 2023
Last Update
December 13 2024
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 462020
2
Indiana University
Indianapolis, Indiana, United States, 46202