Guardant Health, Inc.
Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.
The DCaF study uses a prospective, observational design to characterize how patients make decisions following a Shield(+) screening result and to assess real-world adherence to recommended diagnostic colonoscopy. Because the intervention of interest is the patient's naturally occurring decision-making process-not the performance of the test itself-a non-interventional design is methodologically appropriate and minimizes participant burden. Incorporating decision counseling allows systematic evaluation of changes in preference, decisional conflict, and intention, while linkage to real-world evi…
Inclusion Criteria: * Participant is 45-75 years old at the time of ShieldTM test order. * Participant has a valid Shield(+) test result. * Participant is willing and able to complete the informed consent process * Participant is able to complete the informed consent process and decision counseling session in English Exclusion Criteria: * Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.
During the decision counseling session, JH research staff will review the Complete Diagnostic Evaluation (CDE) infographic and use an online survey to guide the participant through a telephone encounter that involves the identification of patient goals that are likely to affect their decision to have CDE and not to have CDE.
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