Fecal Immunochemical Test Kit Research Articles

Developing a Social Marketing–Based Colorectal Cancer Screening Campaign Centered on Stool-Based Testing for Patients Utilizing Services at a Federally Qualified Healthcare Center

Background More than 50% of colorectal cancer (CRC)–related deaths could be prevented with early detection and treatment. Federally Qualified Healthcare Centers (FQHCs)—safety-net facilities that provide primary care services to uninsured, underinsured and minority patients—report some of the lowest CRC screening rates. Effective CRC screening interventions within FQHCs may help to promote CRC screening utilization among patients from diverse backgrounds. Focus of Article This study was designed to explore average-risk, patient perceptions of facilitators and impediments of using the Fecal Immunochemical Test (FIT) kit for CRC screening within the social marketing framework of the 4 “P’s”—product, price, place, and promotion. Research Aim To conduct formative research with priority populations (i.e., diverse, FQHC patients), assess acceptability of the FIT kit, and identify ways to better meet preferences and needs. Program Design/Approach Qualitative, Focus Groups. Importance to the Social Marketing Field Findings from this study would aid in the future development of a community-based prevention marketing intervention to promote CRC screening within FQHCs that serve diverse patient populations. Methods Focus groups were conducted in English and Spanish with CRC screening age-eligible patients from a South Florida FQHC System. Interview guides were designed to better understand FQHC patient perceptions of CRC Screening via the FIT kit (product) by up-to-date and not up-to-date participants. Additional topics included likes/dislikes (price), preferred location for completing CRC screening and receiving CRC prevention education (place), and strategies for persuasive communication to increase CRC screening among patients who visit FQHCs (promotion). Data were analyzed to identify FIT screening facilitators and impediments using thematic coding in MaxQDA. Results Five focus groups, involving 36 participants aged 50 and older, were conducted. Over half of participants self-identified as Hispanic (36%) or non-Hispanic Black (28%). Key facilitators were the convenience and simplicity of at-home testing (product), presumed affordability of it compared to colonoscopy (price), and ability to return by mail (place). Participants also shared numerous strategies for promotion, including direct referral from Primary Care Providers, mass media campaigns, mailed or electronic reminders from the clinic, and peer advocacy events in churches. Recommendations for Research or Practice Social marketing provides an adequate approach for developing a patient-centered campaign to promote CRC screening uptake at FQHCs. Future CRC screening promotional campaigns at FQHCs should build on the motivation that patients must prioritize their health by emphasizing the convenience of completing CRC screening at home with the capability of mailing it back. Clinics should also work to reduce patient responsibility by developing automated clinic system reminders to openly communicate with patients about CRC screening.

Using Text Messages and Fotonovelas to Increase Return of Home-Mailed Colorectal Cancer Screening Tests: Mixed Methods Evaluation

Background Colorectal cancer (CRC) is currently the second leading cause of cancer-related deaths in the United States; however, it is mostly preventable with appropriate screening and is often treatable when detected at early stages. Many patients enrolled in an urban Federally Qualified Health Center (FQHC) clinic were found to be past due for CRC screening. Objective This study described a quality improvement (QI) project to improve CRC screening rates. This project used bidirectional texting with fotonovela comics and natural language understanding (NLU) to encourage patients to mail fecal immunochemical test (FIT) kits back to the FQHC. Methods The FQHC mailed FIT kits to 11,000 unscreened patients in July 2021. Consistent with the usual care, all patients received 2 text messages and a patient navigator call within the first month of mailing. As part of a QI project, 5241 patients who did not return their FIT kit within 3 months, aged 50-75 years, and spoke either English or Spanish were randomized to either usual care (no further intervention) or intervention (4-week texting campaign with a fotonovela comic and remailing kits if requested) groups. The fotonovela was developed to address known barriers to CRC screening. The texting campaign used NLU to respond to patients’ texts. A mixed methods evaluation used data from SMS text messages and electronic medical records to understand the impact of the QI project on CRC screening rates. Open-ended text messages were analyzed for themes, and interviews were completed with a convenience sample of patients to understand barriers to screening and impact of the fotonovela. Results Of the 2597 participants, 1026 (39.5%) in the intervention group engaged with bidirectional texting. Participating in bidirectional texting was related to language preference (χ22=11.0; P=.004) and age group (χ22=19.0; P<.001). Of the 1026 participants who engaged bidirectionally, 318 (31%) clicked on the fotonovela. Furthermore, 54% (32/59) of the patients clicked on the fotonovela and responded that they loved it, and 36% (21/59) of patients responded that they liked it. The intervention group was more likely to get screened (487/2597, 18.75%) than those in usual care (308/2644, 11.65%; P<.001), and this pattern held, regardless of demographic subgroup (sex, age, screening history, preferred language, and payer type). Interview data (n=16) indicated that the text messages, navigator calls, and fotonovelas were well received and not unduly invasive. Interviewees noted several important barriers to CRC screening and offered suggestions for reducing barriers and increasing screening. Conclusions Texting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group. There were patterns in which patients did not engage bidirectionally; future work should investigate how to ensure that populations are not left out of screening campaigns.

Using Text Messages and Fotonovelas to Increase Return of Home-Mailed Colorectal Cancer Screening Tests: Mixed Methods Evaluation.

Colorectal cancer (CRC) is currently the second leading cause of cancer-related deaths in the United States; however, it is mostly preventable with appropriate screening and is often treatable when detected at early stages. Many patients enrolled in an urban Federally Qualified Health Center (FQHC) clinic were found to be past due for CRC screening. This study described a quality improvement (QI) project to improve CRC screening rates. This project used bidirectional texting with fotonovela comics and natural language understanding (NLU) to encourage patients to mail fecal immunochemical test (FIT) kits back to the FQHC. The FQHC mailed FIT kits to 11,000 unscreened patients in July 2021. Consistent with the usual care, all patients received 2 text messages and a patient navigator call within the first month of mailing. As part of a QI project, 5241 patients who did not return their FIT kit within 3 months, aged 50-75 years, and spoke either English or Spanish were randomized to either usual care (no further intervention) or intervention (4-week texting campaign with a fotonovela comic and remailing kits if requested) groups. The fotonovela was developed to address known barriers to CRC screening. The texting campaign used NLU to respond to patients' texts. A mixed methods evaluation used data from SMS text messages and electronic medical records to understand the impact of the QI project on CRC screening rates. Open-ended text messages were analyzed for themes, and interviews were completed with a convenience sample of patients to understand barriers to screening and impact of the fotonovela. Of the 2597 participants, 1026 (39.5%) in the intervention group engaged with bidirectional texting. Participating in bidirectional texting was related to language preference (χ22=11.0; P=.004) and age group (χ22=19.0; P<.001). Of the 1026 participants who engaged bidirectionally, 318 (31%) clicked on the fotonovela. Furthermore, 54% (32/59) of the patients clicked on the fotonovela and responded that they loved it, and 36% (21/59) of patients responded that they liked it. The intervention group was more likely to get screened (487/2597, 18.75%) than those in usual care (308/2644, 11.65%; P<.001), and this pattern held, regardless of demographic subgroup (sex, age, screening history, preferred language, and payer type). Interview data (n=16) indicated that the text messages, navigator calls, and fotonovelas were well received and not unduly invasive. Interviewees noted several important barriers to CRC screening and offered suggestions for reducing barriers and increasing screening. Texting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group. There were patterns in which patients did not engage bidirectionally; future work should investigate how to ensure that populations are not left out of screening campaigns.

Supply and quality of colonoscopy according to the characteristics of gastroenterologists in the French population-based colorectal-cancer screening program.

Since its complete roll-out in 2009, the French colorectal cancer screening program (CRCSP) experienced 3 major constraints [use of a less efficient Guaiac-test (gFOBT), stopping the supply of Fecal-Immunochemical-Test kits (FIT), and suspension of the program due to the coronavirus disease 2019 (COVID-19)] affecting its effectiveness. To describe the impact of the constraints in terms of changes in the quality of screening-colonoscopy (Quali-Colo). This retrospective cohort study included screening-colonoscopies performed by gastroenterologists between Jan-2010 and Dec-2020 in people aged 50-74 living in Ile-de-France (France). The changes in Quali-colo (Proportion of colonoscopies performed beyond 7 mo (Colo_7 mo), Frequency of serious adverse events (SAE) and Colonoscopy detection rate) were described in a cohort of Gastroenterologists who performed at least one colonoscopy over each of the four periods defined according to the chronology of the constraints [gFOBT: Normal progress of the CRCSP using gFOBT (2010-2014); FIT: Normal progress of the CRCSP using FIT (2015-2018); STOP-FIT: Year (2019) during which the CRCSP experienced the cessation of the supply of test kits; COVID: Program suspension due to the COVID-19 health crisis (2020)]. The link between each dependent variable (Colo_7 mo; SAE occurrence, neoplasm detection rate) and the predictive factors was analyzed in a two-level multivariate hierarchical model. The 533 gastroenterologists (cohort) achieved 21509 screening colonoscopies over gFOBT period, 38352 over FIT, 7342 over STOP-FIT and 7995 over COVID period. The frequency of SAE did not change between periods (gFOBT: 0.3%; FIT: 0.3%; STOP-FIT: 0.3%; and COVID: 0.2%; P = 0.10). The risk of Colo_7 mo doubled between FIT [adjusted odds ratio (aOR): 1.2 (1.1; 1.2)] and STOP-FIT [aOR: 2.4 (2.1; 2.6)]; then, decreased by 40% between STOP-FIT and COVID [aOR: 2.0 (1.8; 2.2)]. Regardless of the period, this Colo_7 mo's risk was twice as high for screening colonoscopy performed in a public hospital [aOR: 2.1 (1.3; 3.6)] compared to screening-colonoscopy performed in a private clinic. The neoplasm detection, which increased by 60% between gFOBT and FIT [aOR: 1.6 (1.5; 1.7)], decreased by 40% between FIT and COVID [aOR: 1.1 (1.0; 1.3)]. The constraints likely affected the time-to-colonoscopy as well as the colonoscopy detection rate without impacting the SAE's occurrence, highlighting the need for a respectable reference time-to-colonoscopy in CRCSP.

A73 EFFECT OF FECAL IMMUNOCHEMICAL TEST CUT-OFF LEVELS ON ADENOMA DETECTION RATE: A SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract Background Adenoma detection rate (ADR) is higher after a positive fecal immunochemical test (FIT) compared to direct screening colonoscopy. Purpose This meta-analysis evaluated how ADR, the rates of advanced adenoma detection (AADR), colorectal cancer detection (CDR), and sessile serrated lesion detection (SSLDR) are affected by different FIT positivity thresholds. Method We searched MEDLINE, EMBASE, CINAHL, and EBM Reviews databases for studies reporting ADR, AADR, CDR, and SSLDR according to different FIT cut-off values in asymptomatic average-risk individuals aged 50 to 74 years old. Data were stratified according to sex, age, time to colonoscopy, publication year, continent, and FIT kit type. Study quality, heterogeneity, and publication bias were assessed. Result(s) Overall, 4280 articles were retrieved and fifty-seven studies were included (332,281 FIT-positive colonoscopies; mean cecal intubation 96.2%; mean age 60.7 years; male 52.1%). Mean ADR was 55.9% (95% CI 53.2% – 58.6%), while mean AADR, CDR, and SSLDR were 27.2% (95% CI 24.3% – 30.1%), 5.4% (95% CI 4.7% – 6.1%), and 3.0% (95% CI 1.7% – 4.6%), respectively. For each 20 μg Hb/g increase in FIT cut-off level, ADR increased by 2.87% (95% CI 1.70% – 4.05%, p &amp;lt; 0.01), AADR increased by 3.90% (95% CI 2.76% – 5.05%, p &amp;lt; 0.01) and CDR by 1.46% (95% CI 0.66% – 2.24%, p &amp;lt; 0.01). Many detection rates were greater amongst males and Europeans. Conclusion(s) ADRs in FIT-positive colonoscopies are influenced by the adopted FIT positivity threshold, and identified targets, importantly, proved to be higher than most current societal recommendations. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared

Implementing a mailed stool sample screening program in clinics providing care for an underserved Hispanic population

Colorectal cancer (CRC) is a leading cause of cancer-related deaths in Hispanics in the US. Despite this, Hispanics are being screened for CRC at a much lower rate than their non-Hispanic white counterparts. Implementing mailed fecal immunochemical tests (FITs) is a cost-effective intervention for increasing CRC screening rates in vulnerable populations, such as Hispanic populations in border metroplexes. We aimed to describe the effect of introductory calls coupled with mailed in-home FIT kits on CRC screening completion in two federally qualified health centers (FQHCs) in a US–Mexico border county. This was a prospective, pragmatic, two-arm intervention study with participants allocated to receive a FIT kit with a reminder call (usual care) or usual care preceded by an introductory call. The primary outcome was the percentage of patients who returned the FIT kits. Participants who returned to the FIT were primarily unemployed (54.4%), had less than a high school education (60.2%), lived in the US for at least 20 years (74.4%), and had poor self-reported health (54.4%). In addition, we observed a statistically significant increase in the absolute rate (4.5%, P = 0.003) of FITs returned when a mailed FIT kit was preceded by an introductory call compared with no initial call. This study demonstrated that adding an introductory phone call significantly improved the screening completion rate in a mailed-out CRC screening intervention in the US–Mexico border population.

Abstract A104: Partnering with primary care to implement evidence based interventions (EBI) to address overdue colorectal cancer (CRC) screening in Connecticut (CT)

Abstract PURPOSE: Partnering with the largest Federally Qualified Health Center (FQHC) in New Haven, CT, the goal is to implement and test 4 evidence-based interventions (EBI) to increase CRC screening, while evaluating real-world implementation. Here, we report on the six-month (approximate) follow up of a cohort of 3,127 patients overdue for CRC screening who received 1 or more EBIs in October 2021. BACKGROUND: Sociocultural and medical concerns are barriers to colonoscopy uptake contributing to disparities in CRC screening. An additional barrier is system level capacity. COVID-19 associated delays exacerbated the existing backlog of individuals overdue for CRC screening, underscoring the need to expand Fecal Immunochemical Testing (FIT) capacity. This was particularly evident in the safety-net primary care setting that serves lower socio-economic status individuals living in urban New Haven, CT. METHODS: We are testing the unique and additive value of multiple evidence-based interventions (EBIs) for increasing CRC screening. The EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and providing assistance from community health workers (CHW). We randomized 3,127 patients overdue for CRC screening to one of 4 arms of the study. All individuals received a reminder from their providers that they were due/overdue for CRC screening with instructions to contact the FQHC. Arm 2 also included information on SDOH barriers, Arm 3 included this same information with offer of navigation from CHW/navigator; and Arm 4 included the offer of CHW educational video and support if needed. Six-month (approximate) outcomes include: 1) Engagement with FQHC resulting in ordered test; 2) completed test. Results by intervention will be assessed at 12 months. RESULTS: Of the 3,127 randomized patients, ages 50-75, 77% were Hispanic (33%) or Black (44%). At 6+ months, a preliminary look at EMR data show that a minimum of 1,275 (40.8%) patients “engaged” with providers resulting in an ordered FIT Kit (n= 1174) or COMPLETED screening colonoscopy that was not associated with a positive FIT result (n = 102). 217 (18.5%) individuals completed the FIT testing with 13 requiring confirmatory colonoscopy (31% completed at this time). Thus, a minimum of 319 (10%) of 3,127 individuals in the cohort completed CRC screening at approximately 6 months post intervention. DISCUSSION: Despite investments in community engagement, stakeholder input, and FIT kit capacity building, the pandemic presented unforeseen challenges. Flexibility and steadfast commitment from FQHC providers and staff were critical to successful implementation during multiple waves of COVID-19, resulting in CRC screening ordered for 41% of cohort within 6 months of intervention. SUMMARY: At 6 months follow up of 3,127 individual who were overdue for CRC screening, one or more of 4 EBIs, in addition to system level efforts to address CRC screening, resulted CRC screening tests ordered for 41% of cohort with at least 10% completed screening. Citation Format: Beth A. Jones, Sakinah C. Suttiratana, Sarah A. DeGiovanni, Steven J. Parra, Levita Robinson, Michael Couturie, Louie Mar Gangcuangco, Denise Stevens. Partnering with primary care to implement evidence based interventions (EBI) to address overdue colorectal cancer (CRC) screening in Connecticut (CT) [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A104.

Abstract B054: FIT distribution in underserved communities in Arkansas

Abstract Colorectal cancer is one of the leading causes of cancer attributed deaths in the U.S. Among the states, Arkansas has one of the highest colorectal cancer mortality rates at 15.5 deaths per 100,000 compared to the national average of 13.4 deaths per 100,000 (American Cancer Society, n.d.). In addition to all Arkansans facing higher incidence and mortality from the disease, more disparities are highlighted when these statistics are examined along racial lines. African Americans face higher incidence and mortality from the disease with African American men facing the highest burden of disease (Arkansas Cancer Facts and Figures 2017, n.d.). The most effective method of colorectal cancer prevention is screening, though many may not have access in many areas in Arkansas. To remedy this issue, the University of Arkansas for Medical Sciences created the Colorectal Cancer Screening and Prevention Program (CCSPP) to increase preventive colorectal cancer care accessibility in underserved communities. This program partners with community services such as food drives to distribute Fecal Immunochemical Test (FIT) kits to community members that can be mailed back to UAMS free of charge. To ensure effective distribution, a script was prepared for community health workers (CHWs) attending these events. CHWs follow the script to determine community member eligibility in the CCSPP followed by FIT kit distribution. Eligible participants have fourteen days to return their completed FIT before they begin receiving weekly reminders via mail or mobile phone. The involvement of CHWs in this program is vital, highlighting the need for effective training. To assure that CHWs have the knowledge necessary for community FIT distribution, a presentation was prepared to provide colorectal cancer screening education and detail the script and consent forms. The objective of the training presentation is to ensure the preparedness of CHWs for community events. The presentation has shown positive results with a two-point increase in the average posttest score of 7.88 after the presentation when compared to the average pretest score of 5.88 before the presentation. This program and methodology allow the most vulnerable Arkansans to receive previously inaccessible preventive care. Though data analysis is still needed to determine the efficacy of this method, this program may serve as an adaptable model for other colorectal cancer prevention initiatives that seek to reach underserved communities. References American Cancer Society. (n.d.). American Cancer Society: Cancer Facts &amp; Statistics. American Cancer Society | Cancer Facts &amp; Statistics. Retrieved from https://cancerstatisticscenter.cancer.org/?_ga=2.234590110.106142599.1654007572-1141503805.1630428031#!/cancer-site/Colorectum Arkansas Cancer Facts and Figures 2017 (Arkansas Cancer Facts and Figures, p. 170). (n.d.-c). Arkansas Department of Health. Retrieved from https://www.healthy.arkansas.gov/images/uploads/publications/ARCancerFacts2017.pdf Citation Format: Sydney T. Baker. FIT distribution in underserved communities in Arkansas [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B054.

Exploring the utility and acceptability of Faecal immunochemical testing (FIT) as a novel intervention for the improvement of colorectal Cancer (CRC) surveillance in individuals with lynch syndrome (FIT for lynch study): a single-arm, prospective, multi-centre, non-randomised study

BackgroundLynch Syndrome (LS) is an inherited cancer predisposition syndrome defined by pathogenic variants in the mismatch repair (MMR) or EPCAM genes. In the United Kingdom, people with LS are advised to undergo biennial colonoscopy from as early as 25 until 75 years of age to mitigate a high lifetime colorectal cancer (CRC) risk, though the consideration of additional surveillance intervention(s) through the application of non-invasive diagnostic devices has yet to be longitudinally observed in LS patients. In this study, we will examine the role of annual faecal immunochemical testing (FIT) alongside biennial colonoscopy for CRC surveillance in people with LS.Methods/designIn this single-arm, prospective, non-randomised study, 400 LS patients will be recruited across 11 National Health Service (NHS) Trusts throughout the United Kingdom. Study inclusion requires a LS diagnosis, between 25 and 73 years old, and a routine surveillance colonoscopy scheduled during the recruitment period. Eligible patients will receive a baseline OC-Sensor™ FIT kit ahead of their colonoscopy, and annually for 3 years thereafter. A pre-paid envelope addressed to the central lab will be included within all patient mailings for the return of FIT kits and relevant study documents. A questionnaire assessing attitudes and perception of FIT will also be included at baseline. All study samples received by the central lab will be assayed on an OC-Sensor™ PLEDIA Analyser. Patients with FIT results of ≥6 μg of Haemoglobin per gram of faeces (f-Hb) at Years 1 and/or 3 will be referred for colonoscopy via an urgent colonoscopy triage pathway.16S rRNA gene V4 amplicon sequencing will be carried out on residual faecal DNA of eligible archived FIT samples to characterise the faecal microbiome.DiscussionFIT may have clinical utility alongside colonoscopic surveillance in people with LS. We have designed a longitudinal study to examine the efficacy of FIT as a non-invasive modality. Potential limitations of this method will be assessed, including false negative or false positive FIT results related to specific morphological features of LS neoplasia or the presence of post-resection anastomotic inflammation. The potential for additional colonoscopies in a subset of participants may also impact on colonoscopic resources and patient acceptability.Trial registrationTrial Registration: ISRCTN, ISRCTN15740250. Registered 13 July 2021.

Implementation of a mailed faecal immunochemical test programme for colorectal cancer screening among Veterans

BackgroundScreening for colorectal cancer (CRC) with faecal immunochemical test (FIT) is effective at reducing CRC mortality. Unfortunately, the COVID-19 pandemic has been associated with deferred care, especially screening for CRC.AimWe...

Modifications in Primary Care Clinics to Continue Colorectal Cancer Screening Promotion During the COVID-19 Pandemic.

COVID-19 caused significant declines in colorectal cancer (CRC) screening. Health systems and clinics, faced with a new rapidly spreading infectious disease, adapted to maintain patient safety and address the effects of the pandemic on healthcare delivery. This study aimed to understand how CDC-funded Colorectal Cancer Control Program recipients and their partner health systems and clinics may have modified evidence-based intervention (EBI) implementation to promote CRC screening during the COVID-19 pandemic; to identify barriers and facilitators to implementing modifications; and to extract lessons that can be applied to support CRC screening, chronic disease management, and clinic resilience in the face of future public health crises. Nine recipients were selected to reflect the diversity inherent among all CRCCP recipients. Recipient and clinic partner staff answered unique sets of pre-interview questions to inform tailoring of interview guides that were developed using constructs from the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) and Consolidated Framework for Implementation Research (CFIR). The study team then interviewed recipient, health system, and clinic partner staff incorporating pre-interview responses to focus each conversation. We employed a rapid qualitative analysis approach then conducted virtual focus groups with recipient representatives to validate emergent themes. Three modifications that emerged from thematic analysis include: (1) offering mailed fecal immunochemical test (FIT) kits for CRC screening with mail or drop off return; (2) increasing the use of patient education and engagement strategies; and (3) increasing the use of or improving automated patient messaging systems. With improved tracking and automated reminder systems, mailed FIT kits paired with tailored patient education and clear instructions for completing the test could help primary care clinics catch up on the backlog of missed screenings during COVID-19. Future research can assess the effectiveness and cost-effectiveness of offering mailed FIT kits on maintaining or improving CRC screening, especially among people who are medically underserved.

S295 Preliminary Observations of FIT Testing for Colorectal Cancer (CRC) Prevention in Two Public Hospitals in New York City

Introduction: Expanding colorectal cancer screening (CRC) on a population level is essential in decreasing CRC mortality. Fecal immunochemical test (FIT) has an important role in improving screening rates. Currently, CRC guidelines recommend annual fecal immunochemical test (FIT) with follow up colonoscopy for all positive tests. We reviewed our experience with FIT testing for CRC screening at our institutions between July 2019 and December 2021. Methods: Eligible primary care clinic patients were given FIT kits with information on how to perform and submit the samples either during face-to-face visits or by mail. Eligible patients were identified as those aged 50-75 due for CRC screening, defined as those without a colonoscopy in the prior 10 years or FIT kit in the prior one year. Among patients who received FIT kits by mail, no standard education was provided about CRC, its screening, or the role of colonoscopy in prevention. A de-identified database was constructed containing demographic variables, process measures, colonoscopy quality measures and outcome measures in FIT+ patients. Results: One hundred seventy-six patients had positive FIT with a positivity rate of 7.2%. Mean age was 60+/-12 years and 52% were female. Follow up colonoscopies were ordered in 73% and performed in 52% of those ordered, representing only 38% of all positive FIT requiring a follow up colonoscopy. Mean and median intervals between +FIT and colonoscopy was 4 months. Of colonoscopies not performed, the patient refused in 54% while system issues were responsible in 21%. Quality metrics, including cecal intubation rates, withdrawal times, and adenoma detection rates (ADR) all met or exceeded benchmarks. The ADR was 58%, almost twice the benchmark, and the detection rate for advanced adenomas was 21%. Eight patients had cancers (11.9%) of which 6 had signs or symptoms and 4 were advanced. There were no interval cancers detected and no complications occurred. Conclusion: Among primary care clinic patients with positive FITs, we found that a low percentage completed their follow up colonoscopies. Among those who did complete colonoscopy, there were high detection rates for both adenomas and advanced adenomas. This highlights the importance of colonoscopy and demonstrates that enhanced pre-FIT educational efforts may be needed to increase adherence to colonoscopy follow up in patients with positive FIT results.

Increasing Fecal Immunochemical Test Return Rates by Implementing Effective "Reminder to Complete Kit" Communication With Participants: A Quality Improvement Study.

BackgroundThe incidence of colorectal cancer (CRC) in the United States is increasing. It remains the second leading cause of cancer death in the United States for men and women combined, mainly due to underutilization of screening methods. The American Cancer Society now recommends that adults aged 45 years and older with an average risk of CRC undergo regular screening with either a high-sensitivity stool-based test or structural (visual) examination, depending on patient preference and test availability. The primary objective of this quality improvement project was to determine if reminder methods, such as telephone or letter reminders, increased the return rate of fecal immunochemical tests (FIT) for CRC screening.MethodologyAt public outreach events and daily clinics in the West Texas Panhandle area, participants in the GET FIT program were provided with FIT kits after completing the education on CRC. Participants who fit the inclusion criteria and had received a FIT kit from the program were included. They were instructed on how to perform the test and mail it back. Participants who did not return the completed kits within two weeks were reminded either through (1) a reminder letter, (2) telephone, or (3) a combination of letter reminder and telephone call every two weeks (±three days) for 60 days or five attempts to contact. We de-identified and analyzed the FIT kit return data from April-September 2019 before analyzing these reminder methods. We then calculated the change in return rates from October 2019 to March 2020. Our goal was to increase the FIT return rates by 25% compared to the baseline return rate.ResultsThe pre-intervention return rate of kits for April-September 2019 was 61.52%, and the post-intervention return rate for October 2019-March 2020 was 71.85%. This rate was equal to an approximately 16.79% increase in return rates that was statistically significant (p < 0.01). There was a significant difference in the method of reminder between the two groups, but no significant differences in gender and race/ethnicity between the two groups. There was a significant difference in return rates between race/ethnicities in the October-March cohort with black and Hispanic participants having the highest return rates of 82.3% and 77.25%, respectively.ConclusionsFIT remains one of the primary options for CRC screening. Due to its lower cost and noninvasiveness, FIT was offered to patients at average risk. We demonstrated an increase in return rates, although we did not meet our target return rate goal for this project. This study was limited due to a gradual increase in coronavirus disease 2019 (COVID-19) cases and a subsequent shift and conversation of ongoing research into COVID-19.

Impact of the COVID-19 Pandemic on Fecal Immunochemical Testing, Colonoscopy Services, and Colorectal Neoplasia Detection in a Large United States Community-based Population

Background & AimsThe COVID-19 pandemic has affected clinical services globally, including colorectal cancer (CRC) screening and diagnostic testing. We investigated the pandemic’s impact on fecal immunochemical test (FIT) screening, colonoscopy utilization, and colorectal neoplasia detection across 21 medical centers in a large integrated health care organization.MethodsWe performed a retrospective cohort study in Kaiser Permanente Northern California patients ages 18 to 89 years in 2019 and 2020 and measured changes in the numbers of mailed, completed, and positive FITs; colonoscopies; and cases of colorectal neoplasia detected by colonoscopy in 2020 vs 2019.ResultsFIT kit mailings ceased in mid-March through April 2020 but then rebounded and there was an 8.7% increase in kits mailed compared with 2019. With the later mailing of FIT kits, there were 9.0% fewer FITs completed and 10.1% fewer positive tests in 2020 vs 2019. Colonoscopy volumes declined 79.4% in April 2020 compared with April 2019 but recovered to near pre-pandemic volumes in September through December, resulting in a 26.9% decline in total colonoscopies performed in 2020. The number of patients diagnosed by colonoscopy with CRC and advanced adenoma declined by 8.7% and 26.9%, respectively, in 2020 vs 2019.ConclusionsThe pandemic led to fewer FIT screenings and colonoscopies in 2020 vs 2019; however, after the lifting of shelter-in-place orders, FIT screenings exceeded, and colonoscopy volumes nearly reached numbers from those same months in 2019. Overall, there was an 8.7% reduction in CRC cases diagnosed by colonoscopy in 2020. These data may help inform the development of strategies for CRC screening and diagnostic testing during future national emergencies.

Colorectal Cancer Screening with Mailed Fecal Immunochemical Tests and Telephone Outreach at a Community Health Center during the COVID-19 Pandemic

Colorectal cancer (CRC) is a common cause of cancer death and disproportionately affects non-Hispanic Black patients. Routine screening with the fecal immunochemical test (FIT) decreases CRC incidence and mortality, and previous literature suggests pairing FIT with live outreach. Screening delays due to the COVID-19 pandemic will likely increase CRC incidence and mortality, especially in underserved communities. We implemented a quality improvement (QI) project at an urban community health center (CHC) in which FIT was paired with live telephone outreach. The intervention increased CRC screening at the CHC by five percentage points. Fecal immunochemical test completion rates significantly increased with successful contact (24.6% for at least one vs. 3.0% for none, p &lt; .0001) and ordering a FIT kit during a patient interaction (28.4% vs. 15.7%, p &lt; .001). This intervention addressed disparities in CRC screening, and the report may have general implications for addressing systemic racism in preventive medicine.

Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial

Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies. We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs. Mailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained. Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.

Association of circulating nucleosomes levels with FIT performance for advanced adenomas in a symptomatic population.

170 Background: The effectiveness of screening using either fecal immunochemical testing (FIT) or colonoscopy in reducing colorectal cancer (CRC) mortality has been demonstrated in previous studies. Nevertheless, the single test sensitivity of FIT for relevant precursor lesions, especially high-risk neoplasms like invasive cancer or advanced adenomas (AA), is a concern. Improving the sensitivity for high-risk neoplasm is critical to improving the effectiveness of screening in reducing CRC incidence and mortality. Dysregulation of histone post-translational modifications (PTMs) has been linked with several cancers including CRC. We investigated the clinical performance of circulating nucleosome levels containing specific histone PTMs in blood, in combination with FIT from symptomatic subjects referred to colonoscopy to evaluate their discriminant power towards CRC and AA. Methods: 10mls whole blood was obtained prior to colonoscopy from 476 patients referred to colonoscopy in National Taiwan University Hospital for surveillance or secondary to bowel symptoms. Patients were classified into 5 groups based on their colonoscopy reports: (i) patient with CRC (n = 67), (ii) patients with AA (n = 60, including 22 with AA≥2cm); (iii) patients with non-AA (n = 123); (iv) patients with non-neoplastic polyps (n = 29); (vi) healthy controls with no endoscopic lesion (n = 197). Plasma samples were analyzed for nucleosome levels using 7 different quantitative immunoassays (Nu.Q assays; Belgian Volition SRL, Belgium) targeting H3.1-nucleosomes or different histone modifications (H3K27Me3-, H3K36Me3-, H3K9Me3-, H3K14Ac-, H3K27Ac- or H3R8Cit-nucleosomes). All study subjects were asked to collect a stool sample at home within 48-hours before the colonoscopy. The fecal samples were assayed with the OC-SENSOR FIT kit (Eiken Chemical Co., Ltd., Tokyo, Japan) for all subjects. Results: At a cut-off of 20µg/g feces, the FIT test showed a sensitivity of 83.5% at 82.1% specificity for CRC +AA vs. Controls. All the CRC patients were detected but 35% of AA were missed, and 7 of which were high-risk adenomas (AA≥2cm). A combination of 2 Nu.Q biomarkers: H3K36Me3 and H3K9Me3 with FIT in a decision tree model showed an improved sensitivity of 98.4% allowing the detection of all CRC patients and 97% of the patients with AA including all high-risk adenomas. The 2 missed AA were one AA below 1cm and one between 1 and 2cm. Unnecessary colonoscopies could be reduced by 28.9% of the control and 20.7% of the non-neoplastic polyps subgroups as both are found negative with this panel of assays. Conclusions: At present, all the symptomatic patients are sent to colonoscopy in clinical practice. Our results indicate that H3K36Me3- and H3K9Me3-nucleosome levels, in combination with FIT in a decision tree model, could detect all CRC patients and all high-risk adenomas and help reduce unnecessary colonoscopies.

Circulating nucleosomes for detection of colorectal cancer and high-risk advanced adenomas.

169 Background: Detection and treatment of early colorectal cancer (CRC) or advanced adenomas (AA) is the key for superior outcomes and fecal immunochemical testing (FIT)-based screening has proven effective in reducing CRC death and the risk of advanced-stage CRC but the discrepancy in the effectiveness was observed between proximal and distal cancers. On the other hand, false-positive results of FIT with 60 % of negative colonoscopy is another concern, considering the burden to the screening participants and the healthcare providers. A blood-based test as an alternative or supplement to FIT has the potential to concurrently enhance the detection of high-risk neoplasms and identify individuals at risk who should then be referred to colonoscopy. We investigated the levels of circulating free nucleosomes containing different epigenetic modifications in patients referred for colonoscopy. Methods: 10mls whole blood was obtained from 520 asymptomatic patients prior to colonoscopy at National Taiwan University Hospital. Patients were classified into 5 groups based on their colonoscopy reports: (i) patient with CRC (n = 33), (ii) patients with AA (n = 123, including 18 with AA &gt; 2cm); (iii) patients with non-AA (n = 168); (iv) patients with non-neoplastic polyps (n = 30); (vi) healthy controls with no endoscopic lesion (n = 166). Plasma samples were analyzed for nucleosome levels using 7 different quantitative immunoassays (Nu.Q assays; Belgian Volition SRL, Belgium) targeting H3.1-nucleosomes or different histone modifications (H3K27Me3-, H3K36Me3-, H3K9Me3-, H3K14Ac-, H3K27Ac- or H3R8Cit-nucleosomes). All study subjects were asked to collect a stool sample at home within 48-hours before the colonoscopy. The fecal samples were assayed with the Eiken OC-SENSOR FIT kit (Eiken Chemical Co., Ltd., Tokyo, Japan) for all study subjects. Results: At a cut-off of 20µg/g feces, the FIT test showed a sensitivity of 92,9% at 17.5% specificity for CRC +AA vs. Controls. All the CRC patients and 83.3% of the high-risk AA (&gt; 2cm) patients were FIT positive. A combination of 2 Nu.Q biomarkers: H3K27Me3 and H3R8Cit with FIT in a logistic regression model showed improved sensitivity of 95% at 20.6% specificity allowing the detection of all CRC patients and 94.3% of AA patients including all the high-risk adenomas. The FIT test detected 46 out of 55 proximal adenomas whereas the combined model could detect 50 proximal adenomas including 3 proximal AA &gt; 2cm not being detected by FIT (p &lt; 0.05). The same combination would reduce unnecessary colonoscopies by 21.8% of the control and 23.3% of the non-neoplastic polyps subgroups compared to 17.5% and 6.7%, respectively with the FIT test alone. Conclusions: Our results indicate that H3K27Me3 and H3R8Cit-nucleosome levels in combination with FIT could improve the detection of proximal high-risk AA and could also provide a non-invasive method to reduce unnecessary colonoscopy.

Faecal immunochemical test for suspected colorectal cancer symptoms: patient survey of usability and acceptability.

BackgroundRecent evidence suggests that the faecal immunochemical test (FIT) can rule out colorectal cancer (CRC) in symptomatic patients. To date, there is no research on usability and perception of FIT for these patients.AimTo measure variation in attitudes and perception of FIT in patients with suspected CRC symptoms.Design & settingA cross-sectional survey of a subset of participants of the NICE FIT study.MethodA questionnaire was co-developed with patients covering four themes on a Likert scale: FIT feasibility, faecal aversion, patient knowledge, and future intentions. Questionnaire and FIT kits were sent to patients with suspected CRC symptoms participating in the NICE FIT study. Logistic regression explored differences in patients’ test perception by ethnic group, language, age, location, deprivation, FIT use, and previous experience.ResultsA total of 1151 questionnaires were analysed; 90.2% (95% confidence interval [CI] = 88.3% to 91.8%) of patients found faecal collection straightforward, 76.3% (95% CI = 73.7% to 78.6%) disagreed FIT was unhygienic, and 78.1% (95% CI = 75.6% to 80.4%) preferred FIT to colonoscopy. Preference for FIT over colonoscopy was weaker in patients aged 40–64 years than those >65 years (odds ratio [OR] 0.60; 95% CI = 0.43 to 0.84). Intention to use FIT again was stronger in patients who successfully used FIT than those unsuccessful (OR 11.08; 95% CI = 2.74 to 44.75), and white compared with non-white patients assessed (OR 3.20; 95% CI = 1.32 to 7.75).ConclusionWhile most patients found FIT practical and hygienic, perception differences were found. Strategies to engage patients with more negative FIT perception should underpin symptomatic FIT pathways.

S250 Increasing Fecal Immunochemical Test Return Rates by Patient Reminders: A Quality Improvement Study

Introduction: The incidence of colorectal cancer (CRC) in the United States is increasing, and it remains the second leading cause of cancer death in the United States for men and women combined. The American Cancer Society now recommends that adults aged 45 years and older with an average risk of CRC undergo regular screening with either a high sensitivity stool-based test or structural (visual) examination, depending on patient preference and test availability. The primary objective of this quality improvement project was to determine if reminder methods, such as telephone or letter reminders, increased the return rate of fecal immunochemical tests (FIT) for colorectal cancer screening. Methods: At public outreach events and daily clinics in the West Texas Panhandle area, participants in the GET FIT program were provided with FIT kits after completing the education on colorectal cancer. Participants who fit the inclusion criteria and had received a FIT kit from the program were included. They were instructed on how to perform the test and mail it back. Participants that did not return the completed kits within two weeks were reminded either by 1) through a reminder letter or 2) by telephone every 2 weeks (+/- 3 days) for 60 days or 5 attempts to contact. We de-identified and analyzed the FIT kit return data from June-November 2019 before instituting these reminder methods. We then calculated the change in return rates from December 2019 to February 2020. Our goal was to increase the FIT return rates by 25% over the baseline return rate. Results: The pre-intervention return rate of kits for June-November 2019 was 67.58%, and the postintervention return rate for December 2019-February 2020 was 81.87%. This rate was equal to an approximately 21% increase in return rates. The average return rate of FIT kits overall was 72.34%. The average rate of returned new patient kits was 69%, and the average % of new patient return kits was 68.51%. We also noticed a significant increase in return of FIT tests after a community cancer screening in October 2019. Conclusion: Fecal immunohistochemical test (FIT) remains one of the primary options for colorectal cancer screening. Due to its lower cost and noninvasiveness, FIT was offered to patients at average risk.We did achieve a significant increase in return rates, although we did not meet our target goal for this project. Our project was limited to studying 3 months post-intervention due to the COVID pandemic and barrier in returning tests. (Table Presented).