Colo-rectal Cancer
Conditions
Keywords
Colo-rectal Cancer, Screening
Brief 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.
Detailed 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 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.
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.
Sponsors
Guardant Health, Inc.
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTDirector of Clinical Trial Operations
Outcome results
None listed