Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 10/18/2018 |
| Start Date: | October 11, 2018 |
| End Date: | June 2020 |
Assessing the Effect of Offering a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion in Patients Who Have Refused Colonoscopy and FIT
Objectives:
Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening
tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of
Americans are up to date with screening, partly because many individuals find these two tests
inconvenient or unacceptable for a variety of reasons. There is an unmet need for a
non-invasive test that does not require bowel preparation or handling stool, and the Septin9
DNA blood test may be an alternative for those individuals who would otherwise remain
unscreened.
Aims:
Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have
declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical
Center
- Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test
who undergo diagnostic colonoscopy
- Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy
Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about
colorectal cancer screening and testing options
We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT
will accept the blood test. We hypothesize this will be driven by the convenience of the
blood test.
Methods:
This will be randomized controlled trial of individuals who have refused colonoscopy and FIT
within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control
group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter
and telephone call. The intervention group will also be invited to participate in the blood
test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total
n=360).
Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening
tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of
Americans are up to date with screening, partly because many individuals find these two tests
inconvenient or unacceptable for a variety of reasons. There is an unmet need for a
non-invasive test that does not require bowel preparation or handling stool, and the Septin9
DNA blood test may be an alternative for those individuals who would otherwise remain
unscreened.
Aims:
Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have
declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical
Center
- Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test
who undergo diagnostic colonoscopy
- Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy
Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about
colorectal cancer screening and testing options
We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT
will accept the blood test. We hypothesize this will be driven by the convenience of the
blood test.
Methods:
This will be randomized controlled trial of individuals who have refused colonoscopy and FIT
within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control
group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter
and telephone call. The intervention group will also be invited to participate in the blood
test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total
n=360).
The proposed study is a randomized controlled trial that will 1) assess the uptake of a CRC
screening blood test among patients who have declined both colonoscopy and FIT in the
previous 6 months, including diagnostic evaluation of positive results and 2) survey patients
about their beliefs and attitudes regarding CRC screening and testing options. All
participants will be primary care patients at the Manhattan VA Medical Center. Based on a
recent internal audit, there were 1502 patients who had at least one primary care visit from
August 2016 through August 2017 and were not up to date with CRC screening. Up-to-date CRC
screening is defined as either 1) a colonoscopy within the past 10 years or 2) FIT within the
past year. We will perform an updated CRC screening audit at the beginning of the study to
obtain the entire pool of eligible patients who are not up to date with screening. Eligible
patients will then be randomized 1:1 to either an intervention group or a control group. All
patients will receive a letter noting that they are not up-to-date on screening and
encouraging them to contact a study number if they choose to screen with colonoscopy or FIT.
Patients who call will speak to a research assistant who is trained in patient navigation and
can facilitate referrals for colonoscopy or FIT. Following the sequential testing approach,
letters addressed to the intervention group will also include an option to participate in the
blood test, with instructions to call the study number to schedule the blood draw. In
addition to the letter, both groups will also receive a follow-up telephone call that
reiterates information in the letter. The research assistant will make and receive all calls
using a standard script. All patients will also be asked to complete a survey about their
beliefs and attitudes regarding CRC screening. The survey will be mailed with the invitation
letter and will also be administered over the telephone by the research assistant. The study
team will notify patients and their primary care physicians of blood test results and will
facilitate a colonoscopy referral for those with positive tests. Primary care physicians will
not be asked to notify the patients or make the colonoscopy referral because most will not
have adequate knowledge of the Septin9 test to provide appropriate patient education.
Participants who are randomized to the blood test arm will undergo phlebotomy, which will be
performed by the study research assistant. The blood sample will be temporarily stored
on-site and then transported to an off-site commercial laboratory (Lenco Diagnostic
Laboratory, Brooklyn, NY) to run the assay.
Clinical outcomes for both the intervention and control group participants will be measured
as a secondary outcome. This includes timing and result of a screening colonoscopy or FIT for
individuals in the controls group as well as diagnostic colonoscopy for participants who had
a positive blood test.
screening blood test among patients who have declined both colonoscopy and FIT in the
previous 6 months, including diagnostic evaluation of positive results and 2) survey patients
about their beliefs and attitudes regarding CRC screening and testing options. All
participants will be primary care patients at the Manhattan VA Medical Center. Based on a
recent internal audit, there were 1502 patients who had at least one primary care visit from
August 2016 through August 2017 and were not up to date with CRC screening. Up-to-date CRC
screening is defined as either 1) a colonoscopy within the past 10 years or 2) FIT within the
past year. We will perform an updated CRC screening audit at the beginning of the study to
obtain the entire pool of eligible patients who are not up to date with screening. Eligible
patients will then be randomized 1:1 to either an intervention group or a control group. All
patients will receive a letter noting that they are not up-to-date on screening and
encouraging them to contact a study number if they choose to screen with colonoscopy or FIT.
Patients who call will speak to a research assistant who is trained in patient navigation and
can facilitate referrals for colonoscopy or FIT. Following the sequential testing approach,
letters addressed to the intervention group will also include an option to participate in the
blood test, with instructions to call the study number to schedule the blood draw. In
addition to the letter, both groups will also receive a follow-up telephone call that
reiterates information in the letter. The research assistant will make and receive all calls
using a standard script. All patients will also be asked to complete a survey about their
beliefs and attitudes regarding CRC screening. The survey will be mailed with the invitation
letter and will also be administered over the telephone by the research assistant. The study
team will notify patients and their primary care physicians of blood test results and will
facilitate a colonoscopy referral for those with positive tests. Primary care physicians will
not be asked to notify the patients or make the colonoscopy referral because most will not
have adequate knowledge of the Septin9 test to provide appropriate patient education.
Participants who are randomized to the blood test arm will undergo phlebotomy, which will be
performed by the study research assistant. The blood sample will be temporarily stored
on-site and then transported to an off-site commercial laboratory (Lenco Diagnostic
Laboratory, Brooklyn, NY) to run the assay.
Clinical outcomes for both the intervention and control group participants will be measured
as a secondary outcome. This includes timing and result of a screening colonoscopy or FIT for
individuals in the controls group as well as diagnostic colonoscopy for participants who had
a positive blood test.
Inclusion Criteria:
- not up-to-date with colorectal cancer screening, defined as a colonoscopy in the past
10 years, a stool test (FOBT/FIT) in the past year, or a flexible sigmoidoscopy in the
past 5 years.
- Declined colorectal cancer screening (both colonoscopy and FIT) in the previous 6
months, which must be documented in the electronic health record
Exclusion Criteria:
- Personal history of colonic adenomas (including sessile serrated adenomas), proximal
hyperplastic polyps, CRC, inflammatory bowel disease, or hereditary gastrointestinal
cancer syndrome
- First degree relative with CRC diagnosed at <60 years of age; family history of
hereditary gastrointestinal cancer syndromes.
- Vulnerable populations
- Adult unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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