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NCT Number: NCT07620535

Decision Counseling and Follow-up 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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. CDE Decisional Conflict

    Time frame: 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.

  2. Factors for CDE Decisional Conflict

    Time frame: From Enrollment to End of Study at 6 months

    Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.

  3. Factors for Changes in CDE Decisional Conflict

    Time frame: From Enrollment to End of Study at 6 months

    Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clinical Trial Operations

CONTACT

[email protected]

855-698-8887

Sponsors and collaborators

Lead sponsor

Guardant Health, Inc.

Industry

Collaborators

  • Thomas Jefferson University

Registry information

Official study title

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

Acronym: DCaF

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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