Trial Title:
Understanding Patient Preference on Colorectal Cancer Screening Options
NCT ID:
NCT05536713
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Guardant SHIELD blood-based colorectal cancer screening test
Description:
The Guardant SHIELD test combines a next-generation sequencing (NGS) based assay and a
protein assay for the qualitative detection of colorectal cancer-derived tumor signal in
the blood of patients at average risk for CRC. The Guardant SHIELD was developed at
Guardant Health's clinical laboratory, a certified laboratory under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), to perform high-complexity clinical
laboratory testing. The test has not been cleared or approved by the U.S. Food and Drug
Administration (FDA); however, its performance has been established through a clinical
trial, the ECLIPSE study (ClinicalTrials.gov Identifier: NCT04136002). The ECLIPSE
clinical trial was a prospective, multi-site registration study and reached the targeted
enrollment of 12,750 patients in December 2021.
Arm group label:
Federally Qualified Health Center 1
Arm group label:
Federally Qualified Health Center 2
Arm group label:
Federally Qualified Health Center 3
Summary:
Early detection by screening significantly reduces mortality from colorectal cancer
(CRC). However, CRC screening rates have plateaued, with a considerable segment of the
population remaining unscreened. Not being up to date with screening was associated with
an approximate 3-fold risk for CRC-related mortality. There are different
well-established CRC screening modalities, including invasive and non-invasive, which
detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening
modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness,
perception of discomfort and embarrassment, logistical challenges, cost, and potential
risks.
Increasing patient compliance and adherence to screening is critical to improving CRC
outcomes. A key to enhancing screening participation is patient acceptance of the testing
method. A blood-based screening test presents an opportunity to overcome some challenging
barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be
part of a standard medical office appointment for a wellness check or scheduled visits to
manage chronic illnesses and be completed at the point of care. This study will examine
patient preference to use a blood-based screening test and compliance with CRC screening
recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal
Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is
particularly poor among medically underserved populations, and most of these vulnerable
individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a
blood-based screening test at FQHCs has the potential to improve CRC screening uptake and
adherence and improve health disparities in medically underserved populations.
This study seeks to answer the following four questions: 1) What is the acceptability of
a blood-based screening as an alternative for patients who failed to complete a prior
order using traditional screening methods? 2) Are patients who failed to comply with
traditional screening methods more likely to comply with a blood-based screening test? 3)
What is the effect of offering a blood-based screening test for patients who are
non-compliance with traditional screening methods on overall CRC screening rates? 4) What
are the facilitators and barriers to implementing the blood-based screening test in
clinical settings?
Detailed description:
Significance
A key to improving screening participation is patient acceptance of the testing method.
Indeed, all screening modalities have benefits over time, and compliance with testing is
essential for successful screening. A blood-based screening test can easily be part of a
routine clinic visit, and the patient can complete the test while still at the clinic.
Patients are accustomed to providing blood samples for other screening tests, such as
cholesterol screening (the national screening rate was 87% in 2019), and the use of a
blood-based CRC screening test is more in line with a patient's expectations of medical
care. On January 19, 2021, the Centers for Medicare and Medicaid Services announced that
the blood-based biomarker test is an appropriate CRC screening once every three years for
Medicare patients when performed in a CLIA-certified laboratory, ordered by a treating
physician, and the blood-based biomarker screening test has a sensitivity greater than or
equal to 74% and a specificity greater than or equal to 90% in the detection of CRC.
The last decades have seen many discovery studies identifying promising biomarkers of
CRC. Improving testing methods for blood-based CRC testing have been developed and
implemented in clinical settings as well. The first blood-based CRC screening test, SEPT9
DNA (Epi proColon), was approved by the FDA in 2016 for persons at average risk for CRC
who have chosen not to undergo screening by existing guideline-recommended methods. This
study will offer a lab-developed Guardant SHIELD blood-based CRC screening test to
patients who failed to complete a stool-based screening test or a colonoscopy six months
after receiving an order from their providers. The Guardant SHIELD blood-based screening
test will be free to the patients with an order from their providers. The Guardant SHIELD
test is a multimodal blood-based colorectal neoplasia detection assay incorporating ctDNA
(circulating tumor DNA) assessment of somatic mutations and tumor-derived methylation and
fragmentomic patterns to maximize early-stage CRC detection sensitivity. Overall, the
Guardant SHIELD blood-based test has a CRC sensitivity of 91% and a specificity of 94%,
meeting the Centers for Medicare and Medicaid Services requirement (74% for sensitivity
and 90% for specificity). All the blood samples collected in this study will be processed
at the CLIA-certified Guardant Health Laboratory.
Compliance by age-eligible patients is essential to the success of any screening program.
However, the acceptance by health care providers and the health care system is also
critical, and especially colonoscopy remains the dominant modality for CRC in the U.S.
Applying the current state of research evidence to health care involves fostering the
adoption, implementation, spread, and sustainability of new evidence-based interventions
to care. Furthermore, transferring effective interventions into real-world settings and
maintaining them is a complicated, long-term process that requires complex phases of
intervention diffusion. In this study, the investigators will examine the inclusion of a
blood-based screening option to increase patient compliance with CRC screening while
developing implementation strategies to facilitate the adoption of a new blood-based
screening test at primary care clinics.
The overall goal of the study is two-fold: 1) examine patient preference when a
blood-based CRC screening option is available, and compliance with CRC screening,
especially among diverse and vulnerable populations; and 2) understand how to increase
the adoption, implementation, and sustainability of an evidence-based screening method to
improve CRC screening uptake and adherence.
Study Design
This study will use an Effectiveness-Implementation (Hybrid Type II) Design to examine
patient preference and screening compliance when a blood-based test screening option is
available and our implementation strategies simultaneously. The Hybrid Type II Design
provides rapid translational gains, practical implementation strategies, and helpful
information for decision-makers. The stepped wedge cluster randomized trial will be used
to examine the blood-based test option in improving screening acceptance and compliance.
The stepped wedge is a pragmatic study design and retains some randomization elements as
a controlled trial. The stepped wedge design includes an initial period of no exposure.
Then one group (or group of clusters) will be randomized to cross from the control to the
intervention. All groups will be exposed to the intervention component but not at the
same time. Each group contributes to exposed and unexposed observations and acts as its
control. In addition, if every cluster shows similar change after crossing to the
intervention condition and does not change at other times, it will provide compelling
evidence that the change resulted from the intervention even with a limited number of
clusters. Furthermore, the feature of multiple data collection points in stepped wedge
design allows the researcher to capture the impact of an intervention when such impact
develops over time or when the intervention needs an initial adjustment period before
becoming embedded in the settings. This feature is valuable for this project when the
diffusion of innovation takes time. In this project, the investigators will first
implement the blood-based screening test at one of the FQHCs. After three months, the
investigators will implement the same intervention at the second FQHC and three months
later at the third FQHC.
Study Sites
The investigators will implement the blood-based screening test at three FQHCs, two in
Illinois and one in Indiana. Each FQHC has a cluster of 10 to 17 primary care clinics.
Study Procedures
1. Recruitment
The investigators will collaborate with the patient navigator at partner sites to
identify patients who failed to complete their screening after six months. The
patient navigator will share study recruitment flyers with the identified patients.
If the patient is interested in the blood-based screening test, the navigator will
refer them to the study coordinator. The study coordinator will provide patient
education on the Guardant SHIELD blood-based screening test, answer questions, and
mail education material to the patient when requested.
2. Informed Consent and Enrollment
Participants who provide informed consent, meet the eligibility criteria, and give a
blood sample for CRC screening will be enrolled. Participants will have their blood
drawn during their next clinic visit after signing the consent form. A phlebotomist
at the clinic will draw the blood and send it to the Guardant Health Laboratory for
testing vid FedEx.
3. Screening Result and Follow-up Guardant Health Laboratory will share the test result
with the ordering provider. Ordering providers will discuss the test finding with
their patients and refer patients to follow-up colonoscopy in the case of a positive
test result. Before the implementation, providers at our partner FQHCs will attend a
training session delivered by Guardant Health scientists on the Guardant SHIELD
blood-based screening test, including interpreting the results. If a study
participant receives a positive result, the patient navigator at our partner sites
and our study coordinator will assist with colonoscopy scheduling and educate on
bowel preparation. The investigators will work with Guardant Health to support
uninsured or underinsured patients who have difficulty accessing colonoscopy due to
the cost.
Study Endpoints
1. Primary Endpoint
The primary endpoint is to examine whether the availability of a blood-based
screening option, which can be done at the point of service and is familiar to
patients, will improve patient compliance with recommended CRC screening. The
investigators will assess the effectiveness of the primary endpoint by calculating
the number of participants who, otherwise, will not have participated in the CRC
screening and completed the Guardant SHIELD blood-based screening test. The
investigators will compare the differences within and between health centers and the
changes over time. Since the blood-based screening test is a two-step strategy and
patients with a positive result must complete a follow-up colonoscopy to maximize
the benefit of the screening, the investigators will include colonoscopy referral
and completion rates as secondary outcomes during the primary endpoint analysis.
2. Secondary Endpoint
The secondary endpoint analysis is to determine whether the implementation strategies
accelerate the adoption and implementation of a blood-based screening test into routine
practice. Adoption takes time and is slow at the start, more rapid as adoption increases
and then levels off. If the adoption does not reach the critical mass, the process can
stall. The adoption rate indicates how fast an idea reaches a certain percentage of
people. This study will monitor the adoption rates over time and how long it takes to
achieve 2.5%, 16%, and 50% adoption rates (adoption rate = the number of new users /
total number of potential users). The investigators will monitor the adoption rate
quarterly. In addition, the investigators will also monitor the intensity of use.
Data Collection
During the first three months, The investigators will collect baseline data on
non-compliance rates for stool-based tests and colonoscopy. After starting the
implementation process, the investigators will collect primary outcome data each quarter
until the project's conclusion. At the patient level, the investigators will collect
de-identified patient demographic information from EHR, including 1) Health insurance
coverage (Yes/No), 2) Race/ethnicity, gender, age, and 3) CRC screening up-to-date status
(Yes/No). At the clinic and provider levels, the investigators will collect data on
blood-based screening test order rates, blood-based test completion rates, and colorectal
cancer screening rates. Since a blood-based screening test is a two-stage strategy and a
positive result requires a follow-up colonoscopy, this study will include colonoscopy
referral rates, completion rates, and time to colonoscopy completion as secondary
outcomes. The investigators will also collect data on patient experiences, including
convenience, easiness, and the likelihood of using a blood-based screening test again.
Criteria for eligibility:
Study pop:
Patients who are age-eligible for colorectal cancer screening based on the U.S.
Preventive Service Task Force recommendation guidelines have an average risk for
colorectal cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Between 45-75 years of age
- Have an average risk for colorectal cancer
- A patient at one of our partner FQHCs
- Received a screening order (either using a stool-based test or colonoscopy) six
months ago and failed or refused to complete the screening test
- Able to comprehend and willing to give informed consent
- Able and willing to provide a blood sample per protocol
Exclusion Criteria:
1. Family history
- One first-degree relative diagnosed with CRC or advanced adenoma at age < 60
years
- Two first-degree relatives diagnosed with CRC or advanced adenoma at any age
- Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or
Familial Adenomatous and Polyposis (FAP)
2. Personal History
- History of CRC or adenoma
- History of cancers
- History of inflammatory bowel disease, including chronic ulcerative colitis and
Crohn's disease
- Have a recorded up-to-date CRC screening
- Blood product transfusion in the past 120 days
- A medical condition that, in the opinion of the patient's health provider,
should preclude enrollment in the study
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
PCC Community Wellness Center
Address:
City:
Chicago
Zip:
60302
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chief Medical Officer
Phone:
708-383-0113
Email:
PLuning@pccwellness.org
Contact backup:
Last name:
Case Management Coordinator Supervisor
Phone:
708-383-0113
Email:
JReuteler@pccwellness.org
Start date:
February 9, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Milton S. Hershey Medical Center
Agency class:
Other
Source:
Milton S. Hershey Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05536713
