This clinical trial compares screening behavior and decision quality of patients eligible for colorectal cancer (CRC) screening who view a decision aid that includes general information about CRC, and colonoscopy and stool tests (i.e. fecal immunochemical test [FIT] and Cologuard) to those who view the same decision aid with a personalized message about their risk of having an advanced colorectal neoplasm (ACN). The study also aims to compare the impact of sending an email notification to enrolled patients’ providers, half of whom will receive a notification that informs them of their patient’s current risk of ACN and implications for screening test choice, and half will receive a notification that just informs them that their patient is due for CRC screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04683731.
PRIMARY OBJECTIVE:
I. To measure the impact on patient decision quality and screening uptake of providing patients and their providers with personalized messages about the patient’s current risk of having advanced colorectal neoplasia (ACN).
II. To examine mediators and moderators of the interventions’ effectiveness.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients view decision aid consisting of a PowerPoint presentation video over 10 minutes about the advantages and disadvantages of colonoscopy and stool testing with the FIT and deoxyribonucleic acid (DNA)+FIT (Cologuard). Providers receive a generic message informing them that their enrolled patient is due for CRC screening. Participants complete surveys at baseline, 4-7 days after provider visit and up to 6 months.
GROUP II: Patients view decision aid as in group I followed by a personalized video message over 4 minutes explaining the risk tool, the participant’s score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. Providers receive a generic message as in group I. Participants complete surveys at baseline, 4-7 days after provider visit and up to 6 months.
GROUP III: Patients view decision aid as in group I. Providers receive a personalized message disclosing the patient's ACN risk information and implications for screening decision and test choice. Participants complete surveys at baseline, 4-7 days after provider visit and up to 6 months.
GROUP IV: Patients view decision aid and personalized message as in group II. Providers receive a personalized message as in group III. Participants complete surveys at baseline, 4-7 days after provider visit and up to 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorPeter H. Schwartz
