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| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHIELD Positive with Completed Colonoscopy | Patients who are intending to undergo a complete a diagnostic evaluation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Counseling Session | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CDE Decisional Conflict | 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. | From Enrollment to the end of study at 6 months |
| Factors for CDE Decisional Conflict | Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result. | From Enrollment to End of Study at 6 months |
| Factors for Changes in CDE Decisional Conflict | Identify factors associated with change in CDE preference, decisional conflict, intention, and preference. | From Enrollment to End of Study at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with a recent clinically ordered Shieldâ„¢ test result who received a positive (abnormal) screening (Shield+) result.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trial Operations | Contact | 855-698-8887 | dcaf@guardanthealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Center | Philadelphia | Pennsylvania | 19114 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |