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The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent to CRC guidelines.
Full description
Subjects 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Subjects will be randomized to one of three intervention arms: no video (arm 1), brief CRC screening video (arm 2), or enhanced CRC screening video (arm 3). Subjects in all intervention arms will complete surveys regarding intention to screen for CRC and preference for screening modality prior to viewing the video, after the video, and after their index appointment. Subjects will be surveyed, and medical information collected, annually for up to six years to assess adherence to CRC screening and CRC screening outcomes.
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Inclusion criteria
Exclusion criteria
Subject has symptoms or signs that require immediate, or near term referral for diagnostic or therapeutic colonoscopy.
Subject has a personal history of colorectal cancer (CRC) or colonic adenomatous or sessile serrated polyps.
Subject has a personal history of inflammatory bowel disease.
Subject has a family history of CRC in at least one first- or second-degree relative diagnosed prior to age 60 and/or at least 2 first-degree relatives diagnosed with CRC at any age.
Subject has a personal diagnosis or family history of any of the following conditions:
Subject has a diagnosis of Cronkhite-Canada Syndrome
Subject is current with CRC screening, including gFOBT or FIT within the preceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopy or CT colonography within the preceding 5 years, or colonoscopy within the preceding 10 years. Subjects can be enrolled up to 3 months prior to screening due date.
Subject has any condition that in the opinion of the Investigator should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.
5,280 participants in 3 patient groups
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Central trial contact
Haley Bowser
Data sourced from clinicaltrials.gov
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