Decision Counseling and Follow-up for Shield+ Patients

Decision Counseling and Follow-up (DCaF) for Shield+ Patients

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 evidence (RWE) claims data provides an efficient and objective method for determining colonoscopy completion. This approach enables the study to identify behavioral, clinical, and system-level factors associated with follow-up adherence without altering standard clinical care.

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.