Decision 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.
Study 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.
Eligibility
Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
CDE Decisional Conflict — From Enrollment to the end of study at 6 months Determine the level of preference for, decisional conflict related to, intention to have CDE following a Shield+ result at baseline and after decision counseling and assess change.
Factors for CDE Decisional Conflict — From Enrollment to End of Study at 6 months Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.
Factors for Changes in CDE Decisional Conflict — From Enrollment to End of Study at 6 months Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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