The growth of the telehealth market has highlighted a need for alternative remote outreach methods to reach individuals for preventive/wellness screens. Unlike some other screening tools, such as colonoscopy, fecal immunochemical test (FIT) can be conducted by the person at home and has become an attractive option during the COVID-19 pandemic. Previous studies regarding outreach and FIT testing focused on short-term metrics, such as a one-time intervention and limited follow-up. These studies also did not account for FIT compliance before the studies, which can be a strong predictor of one-time FIT compliance.
In a recent multiyear, randomized study published in Clinical Gastroenterology and Hepatology, researchers looked at FIT outreach outcomes. The study included 10,771 patients from eight San Francisco Health Network clinics, aged 50-75 years, who were not up-to-date (UTD) with colorectal cancer (CRC) screening. Patients were first stratified by the clinic, gender, race/ethnicity, and FIT history and then randomly assigned to one group. The two groups were: outreach intervention and usual care. The outreach group received a mailed postcard and a phone call, followed by a FIT kit sent to the patient’s home. Patients who did not return the FIT kit after two weeks received two reminder calls. Usual care was left for the participating clinics to decide, including reminder calls, educational material, and coaching.
Follow-ups for participants went up to 2.5 years unless the patient:
- Was lost to follow-up
- Was 365 days out after an abnormal FIT result
- Had gotten a colonoscopy
- Had turned 76
- Had died
At the end of the study, the cumulative proportion of patients with FIT completion in the outreach group was 73.2%, versus 55.1% in the usual care group. Patients who had previously done a FIT were more likely to complete FIT through mailed outreach. Outreach also increased FIT completion in patients who had not previously done one. However, the second cycle of mailed outreach did not increase completion in those who had not done so in the first cycle. Patients assigned to outreach were also more likely to be consistently adherent (2 of 2 FIT completed) versus intermittently (1 of 2) or non-adherent (0 of 2). The outreach group also had significantly more abnormal FIT results than the usual care group. As a result, more colonoscopies were also conducted in the outreach groups.
Overall, the study’s findings show that the outreach group had more benefits and compliance for FIT than the usual care group. Although there was no significant difference in CRC cases between the two groups, the outreach group did have more abnormal FIT results, leading to earlier detection and decreasing CRC risk over time.
Limitations to the study included the use of safety-net populations, who are more likely to have changes in contact information, which could impact overall outreach. Stool-based option successes also require adherence to both FIT and colonoscopy follow-ups for abnormal results. However, the authors did not evaluate compliance with colonoscopy follow-ups in this study. While there was an overall increase in CRC screenings from FIT outreach, more research can be done on how other metrics impact the results. In the meantime, outreach and FIT are beneficial in the current telehealth era that we are in.
COVID-19 Pandemic Altered Patient Attitudes Towards At-Home CRC Screening
At the American College of Surgeons, Clinical Congress 2021, in October, 2021, Kristine Kenning, MD, chief general surgery resident at Virginia Commonwealth University, presented results from a survey among 765 age-eligible (50 and older) adults for colorectal cancer (CRC) screening. Her team found that about 30% of those who participated on the survey had completed stool-based tests when compared to before the pandemic.
The study also looked at how barriers to screening changed before and after the pandemic. They found about a 5% increase in the percentage of unemployed respondents, from 2.6% to 7.4%. Of the 41% of respondents who were concerned about co-pays, 57.6% said they delayed undergoing screening as a consequence.
It was also found that:
FOBT analyses blood in feces that is not visible to the naked eye. A positive result for this test would indicate lesions present in the digestive tract.
Impact of the Pandemic
Perception towards at-home tests and colonoscopies have changed as a result of the pandemic. More people now than before are uncomfortable undergoing a colonoscopy because of the associated costs and potential for exposure to COVID-19. At-home tests such as FOBTs may be potential alternatives to a colonoscopy.
Dr. Kenning explained the significance of her research findings in the Clinical Congress 2021 press release. “The key message from our findings is that barriers to screening have increased during the pandemic, and we have to find a way to work with the community to increase those rates. Our study found that people are compliant with, and willing to do, home-based fecal occult blood testing. This test provides a very important way for us to increase screening for colorectal cancer.”
Dr. Kenning noted that a larger survey is in the planning with principal investigator Carrie Miller, PhD, MPH, to further explore the changes in attitudes towards CRC screening.
Gargi Patel is a Colon Cancer Prevention Intern with the Colon Cancer Foundation.
New Blood Test for CRC Coming Soon, Guardant Health’s LUNAR-2
Recently at the American College of Gastroenterology’s 2021 Annual Scientific Meeting, Dr. Hee Cheol Kim, Professor of Surgery at Samsung Medical Center in Seoul, South Korea, presented an abstract detailing results from a study on Guardant Health’s LUNAR-2 blood test for colorectal cancer (CRC). It was found that the test had a sensitivity (percent of CRC patients identified as having CRC) of 96% and a specificity (percent of patients without CRC as not having CRC) of 94%.
LUNAR-2 is a multimodal circulating tumor DNA (ctDNA) blood test. ctDNA is the tiny amount of DNA from cancer cells that moves freely in the bloodstream and can be used as a biomarker for cancer diagnosis. Tests for ctDNA are often very sensitive to the smallest amount of tumor DNA and can catch cancer much earlier than physical screening tests such as a colonoscopy.
The efficacy of LUNAR-2 as a CRC screening test was evaluated retrospectively in a cohort of 699 patients with stage 1, 2, or 3 disease. Furthermore, LUNAR-2 was able to identify 90% of asymptomatic patients. This is significant because early detection is strongly associated with improved survival.
Currently, a larger trial with more than 10,000 patients is underway (ECLIPSE study) to further test whether LUNAR-2 is able to diagnose early-stage CRC. Enrollment is expected to be completed later this year.
It is important to have a less invasive and simpler test for CRC screening because of the challenges in adherence to timely screening. Colonoscopy, which is recommended once in 10 years, requires general anesthesia and is considered a medical procedure. Additionally, colonoscopy can be expensive. Stool-based screening tests, such as a FIT test or a FIT-DNA test, have to be done frequently and many people feel uncomfortable getting them done.
Guardant Health Co-CEO AmirAli Talasaz explains in the company press release why a blood test is critical right now, in a post-COVID world. “During the COVID-19 pandemic, screening rates have dropped, wellness visits have declined, and postponements of non-emergency medical procedures have made it harder for people to complete life-saving CRC screening. The study results show that the LUNAR-2 test could provide both patients and physicians with an easy-to-use and highly accurate CRC screening alternative in the form of a blood test.”
The Colon Cancer Foundation Launches the 3000 Squats in November Facebook Challenge
The Colon Cancer Foundation (CCF)’s 3000 Squats in November Facebook challenge kicked off on November 1st, 2021. The month-long squat challenge is the first time we have created a fitness-focused Facebook fundraiser since the launch of the Colon Cancer Challenge 17 years ago.
All of CCF’s previous fundraising challenges have been associated with running—whether it was a 5K or a marathon. This one-of-a-kind squat challenge is the first by CCF where everyone, regardless of their physical fitness, can join in. The squat challenge is not as physically intense as our previous 5K or marathon fundraisers. Remember: regular physical activity reduces the risk of colon cancer by 40%-50%!
This difference is even more critical given the recently announced colorectal cancer (CRC) screening guidelines changes. The United States Preventive Services Task Force (USPSTF) recently changed their guidelines for CRC screening. Now all adults at an average risk of developing CRC are recommended to start CRC screening at age 45, instead of 50. Annual stool based screening (FIT or sDNA-FIT) is recommended. Colonoscopy is recommended every 10 years. This recent change in recommendation makes our squat challenge even more significant in that we need to get more people active and aware of the risk factors of CRC starting at a younger age.
Here are a few words about the Challenge from our Operations Manager, Marcline St-Germain :
“I’m feeling hopeful. This is completely different then the challenges we are used to, but it’s good to change things up from time to time and so far it looks like we are getting a good response. For a couple of years now, CCF has conducted birthday fundraisers on Facebook but they are different in that the fundraisers just choose to fundraise for us without us having to reach out to anyone.”
Speaking about the impact of the Facebook challenge, Ms. St-Germain added, “I was surprised to see how many people joined the challenge. The group went from a couple of hundred to over one thousand members in less than a week! That reminded me of how big of a platform Facebook really is.” She is also looking forward to conducting more Facebook challenges in the future because they allow many more people to participate from the comfort of their own homes.
JAMA Study Finds Uptick in mt-sDNA Use, Drop in FOBT for CRC Screening
A longitudinal study that evaluated colorectal cancer (CRC) screening habits of average-risk adults found an increase in screening rates between 2011 and 2019, although it did fall short of the 80% goal set by the National Colorectal Cancer Roundtable. Interestingly, the use of multitarget stool DNA test (mt-sDNA) increased between 2016 and 2019—once there was a reimbursement code for the test post–FDA approval. Fecal occult blood testing (FOBT) use, meanwhile, saw a decline during that same period.
The researchers used commercial and Medicare claims databases to draw information on CRC screening use between August 1, 2011, and August 31, 2019. The actual 18-year study period was split into the pre-mt-sDNA period (August 1, 2011-July 31, 2014) and the post-mt-sDNA period (August 1, 2016-July 31, 2019). Only those enrollees who were between 45-67 years old on August 1, 2011, and were at an average risk of developing CRC, were included in the study. This inclusion criteria made up nearly 98,000 individuals, with a mean age of 50.8 years; 55.5% of them were women. About 62% of them were over 50 years old, and about 38% were aged between 45 and 49 years on August 1, 2011.
The analysis found a steady annual increase in up-to-date screening, from 50.4% in 2011-2012 to 69.7% in the final measurement year (2018-2019). While the 45-49 years old had low screening rates (25.8%) in the early years, the difference between age groups disappeared by the end of the study period (67.7%). The most interesting data were utilization patterns of the kinds of screening tests among those 50 and over:
Specifically in the 45-49 age group, colonoscopy use increased while use of FIT and FOBT decreased over the study period. However, use of mt-sDNA increased once the test was launched.
The authors attribute the successful increase in CRC screening utilization to multiple factors:
Colon Cancer Foundation Supports S.4111/A4668 to Protect Patients From Non-Medical Switching
The Colon Cancer Foundation, in partnership with 65 other organizations, has signed a memorandum urging New York Governor Kathy Hochul to sign S.4111/A4668 into law.
S.4111 Breslin/A.4668 Peoples-Stokes, which passed both the New York State Senate and the Assembly in April and May 2021, respectively, with bipartisan support, is a bill that prohibits mid-year formulary changes. (A formulary is a list of drugs that are covered by a prescription drug plan.) This in turn will prevent health plans from stopping coverage for a patient’s prescription drug in the middle of a coverage year, unless the switching is medically necessary—what is often referred to as non-medical switching.
Non-medical switching is described as changing a patient’s prescription medication to a clinically different non-generic alternative for non-clinical reasons, even if the patient is responding to his or her current drug. The reason for the switch is not based on a poor clinical response, treatment side effects, or non-adherence to treatment. The decision is often made by health plans to save costs.
A decision to replace a medication that a patient may be responding to may be particularly troublesome for patients with chronic disease or complex conditions. An online survey on non-medical switching among oncologists found:
The survey found that non-medical switching occurs across several specialties and that it can adversely affect patient care. Similar results were noted in a separate survey that sampled over a 1,000 physicians—physicians felt non-medical switching negatively impacted treatment efficacy, side effects, medication adherence, out-of-pocket costs, and medication errors.
Along with the adverse clinical impact of non-medical switching, there is the aspect of fairness. While consumers are bound by law to pay the premium, co-pays, deductibles, and honor the contract’s terms, insurance plans are not held to those same standards. Enrollees choose a certain plan based on their medical care and prescription needs. Being forced to switch in the middle of that contract is unfair on the patient.
We hope that Governor Hochul will support the bill and make it a law.
Performance Measurement to Enforce CRC Screening Among Medicaid Enrollees
The Medicaid Performance Measures work group has voted to add the colorectal cancer (CRC) screening measure to the 2022 Adults Core Set. This will be taken into consideration when CMS finalizes the measures to be included in the core set. While this is not the end game, it is a good start for stakeholders to begin thinking about meeting CRC screening benchmarks within their Medicaid population.
According to 2018 data from the American Cancer Society, only 54% of age-eligible (50 years and above at that time) Medicaid-insured adults were current with their CRC screening as opposed to 65% of those covered by private health plans, 73% of those covered under Medicare or Medicare and Medicaid, and 80% of Medicare- and privately insured adults. Research has shown that low socioeconomic status and being covered by Medicaid increases the risk of poor CRC prognosis: those covered by Medicaid have a 50% higher likelihood of being diagnosed at late stage of the disease and dying from it.
The reason for this? CMS does not mandate reporting on Medicaid CRC screening rates. In contrast, Medicare CRC screening rates are a core reporting requirement for Medicare Advantage plans, which along with other HEDIS measures influence the reimbursement bonuses and other benefits for health plans. This then forces the health plan to pay attention to, and perform well on, the measures and results in better health outcomes for enrollees. The proof of this concept was evident from the BeneFIT program that monitored CRC screening rates among two Medicaid managed care plans: one in Oregon (which was required to report on the screening rates) and the other in Washington state (reporting was not mandated). While the Washington plan stopped mailing FIT kits to its Medicaid enrollees by the second year of the program, the Orgon plan expanded its program to add more Medicaid enrollees.
The hope is that once CMS integrates the measure in the 2022 Adult Core Set, CRC screening rates in the Medicaid population will improve and will translate into prevention, earlier detection, and potentially reduced mortality from CRC.
Clinical Alert: Preventing the Rise in Early-age Onset Colorectal Cancer
Did you know that the incidence and mortality rates of early-age onset colorectal cancer (EAO-CRC) have skyrocketed in recent years? Many of these patients may not have been screened yet for CRC, and may be misdiagnosed with another gastrointestinal condition. A lack of awareness of EAO-CRC combined with the potential for misdiagnosis and myriad other factors has contributed to patients under the age of 55 being 58% more likely to be diagnosed with advanced CRC than their older counterparts. While individuals with a known family health history of CRC may be more likely to get screened at a younger age, 70% of EAO-CRC cases occur in individuals with no known risk factors, who, therefore, may not have any knowledge of CRC symptoms and may not be inclined to consult a doctor if symptoms arise.
The rapid rise in EAO-CRC cases makes it vital for primary care physicians to be acutely aware of CRC symptoms (e.g. rectal bleeding and abdominal pain), and not hesitate to refer patients to get screened even if they do not have a family history of the disease or are young. CRC is largely treatable if diagnosed at a localized stage, so it is imperative that patients are made aware of the symptoms and that physicians respond to their concerns appropriately. To learn more about what you can do to combat the rise of EAO-CRC, please take a look at the infographic below.
Final Clinical Alert Infographic Download
Nutrition and Colorectal Cancer Prevention
Insurance Coverage for Colorectal Cancer Screening
Fecal Immunochemical Test (FIT) Outreach Shown to Increase CRC Screening Compliance
The growth of the telehealth market has highlighted a need for alternative remote outreach methods to reach individuals for preventive/wellness screens. Unlike some other screening tools, such as colonoscopy, fecal immunochemical test (FIT) can be conducted by the person at home and has become an attractive option during the COVID-19 pandemic. Previous studies regarding outreach and FIT testing focused on short-term metrics, such as a one-time intervention and limited follow-up. These studies also did not account for FIT compliance before the studies, which can be a strong predictor of one-time FIT compliance.
In a recent multiyear, randomized study published in Clinical Gastroenterology and Hepatology, researchers looked at FIT outreach outcomes. The study included 10,771 patients from eight San Francisco Health Network clinics, aged 50-75 years, who were not up-to-date (UTD) with colorectal cancer (CRC) screening. Patients were first stratified by the clinic, gender, race/ethnicity, and FIT history and then randomly assigned to one group. The two groups were: outreach intervention and usual care. The outreach group received a mailed postcard and a phone call, followed by a FIT kit sent to the patient’s home. Patients who did not return the FIT kit after two weeks received two reminder calls. Usual care was left for the participating clinics to decide, including reminder calls, educational material, and coaching.
Follow-ups for participants went up to 2.5 years unless the patient:
At the end of the study, the cumulative proportion of patients with FIT completion in the outreach group was 73.2%, versus 55.1% in the usual care group. Patients who had previously done a FIT were more likely to complete FIT through mailed outreach. Outreach also increased FIT completion in patients who had not previously done one. However, the second cycle of mailed outreach did not increase completion in those who had not done so in the first cycle. Patients assigned to outreach were also more likely to be consistently adherent (2 of 2 FIT completed) versus intermittently (1 of 2) or non-adherent (0 of 2). The outreach group also had significantly more abnormal FIT results than the usual care group. As a result, more colonoscopies were also conducted in the outreach groups.
Overall, the study’s findings show that the outreach group had more benefits and compliance for FIT than the usual care group. Although there was no significant difference in CRC cases between the two groups, the outreach group did have more abnormal FIT results, leading to earlier detection and decreasing CRC risk over time.
Limitations to the study included the use of safety-net populations, who are more likely to have changes in contact information, which could impact overall outreach. Stool-based option successes also require adherence to both FIT and colonoscopy follow-ups for abnormal results. However, the authors did not evaluate compliance with colonoscopy follow-ups in this study. While there was an overall increase in CRC screenings from FIT outreach, more research can be done on how other metrics impact the results. In the meantime, outreach and FIT are beneficial in the current telehealth era that we are in.