Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
2004 participants
INTERVENTIONAL
2022-03-17
2023-06-15
Brief Summary
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Detailed Description
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Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment).
Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Guardant Shield Blood Test
Patients will have the Guardant Shield blood test for colorectal cancer screening.
GuardantSHIELD Blood Test
The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC
Standard of Care
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
No interventions assigned to this group
Interventions
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GuardantSHIELD Blood Test
The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC
Eligibility Criteria
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Inclusion Criteria
* Received a FIT test in the last 3-9 months yet did not return their FIT
* Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks
* Able and willing to provide informed consent if in the intervention arm
Exclusion Criteria
* Having a legal authorized representative
* Non-English speakers
45 Years
75 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Gloria Coronado, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Northwest
Portland, Oregon, United States
Countries
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References
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Coronado GD, Jenkins CL, Shuster E, Johnson C, Amy D, Cook J, Sahnow S, Zepp JM, Mummadi R. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024 Mar 7;73(4):622-628. doi: 10.1136/gutjnl-2023-330980.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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KPNW Guardant [1866832-1]
Identifier Type: -
Identifier Source: org_study_id