Health TrialsbyHealthPanel

Decision Counseling and Follow-up for Shield+ Patients

ConditionColo-rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorGuardant Health, Inc.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Adults with a recent clinically ordered Shield™ test result who received a positive (abnormal) screening (Shield+) result.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: SHIELD Positive with Completed Colonoscopy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From Enrollment to the end of study at 6 months
2

Factors for CDE Decisional Conflict

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

Time frame
From Enrollment to End of Study at 6 months
3

Factors for Changes in CDE Decisional Conflict

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

Time frame
From Enrollment to End of Study at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guardant Health, Inc.

Lead sponsor

Thomas Jefferson University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: