Decision Counseling and Follow-up (DCaF) for Shield+ Patients
Guardant Health, Inc.
Summary
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.
Description
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…
Eligibility
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- BehavioralDecision Counseling Session
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.
Location
- Jefferson CenterPhiladelphia, Pennsylvania