FluFit Program Components & Flow Diagram. FIT Not Completed. FIT Not Completed. Postcards and Phone. FIT Completed. FIT Completed

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1 FluFit Program Components & Flow Diagram GOAL: Increase colorectal cancer screening rates by offering home FIT kits to eligible patients during annual flu shot activities Program Planning & Implementation Designate a FluFIT program leader Program leader assigns clinic staff to participate Clinic staff completes training Clinic team approves program plans Advertise program to patients with posters and postcards Daily Implementation Daily supervision by program leader Trained staff offers program every day during flu shot season EHR used to assess FIT eligibility when possible FIT given to eligible patients before flu shot is given FIT kits prepackaged with all selected patient instructions and educational materials Use postage paid return envelopes Results Follow-up FIT Not Completed Normal Results Notify patient and primary care provider Reminder to repeat FIT in one year FIT Not Completed Postcards and Phone Tracking Results Follow-up Abnormal Results Notify patient and primary care provider Arrange diagnostic colonoscopy FIT Completed FIT Completed Patients mail completed tests to lab for processing Clinic checks for results FIT kits are tracked for completion

2 Colorectal Cancer and FIT/FOBT: Facts and Talking Points for Staff to Use with Patients Facts about colorectal cancer and screening: 2nd leading cause of cancer death in the United States More than 50,000 Americans die of colorectal cancer each year Colorectal cancer is often preventable with screening Early detection and treatment saves lives There are more than 1 million colorectal cancer survivors in the United States Colorectal cancer screening is recommended between the ages of 50 and 75 Facts about FOBT and FIT kits They work by detecting small amounts of blood that can come from colon polyps or early stage colorectal cancer If done every year, they can help find polyps and cancers before they become life threatening. Studies have shown that high quality FOBT and FIT kits, if done correctly and followed up well, can be similarly effective to colonoscopy for most people. They are done at home and mailed into the lab. If the FOBT or FIT results are abnormal, you need to get a colonoscopy. If you choose to get FOBT or FIT, you need to do it every year, just like a flu shot Useful Talking Points for Use with Patients We have something extra to offer you today! It looks like you are due for a home colon test Colon cancer screening can save lives Just like a flu shot, all our doctors and nurses recommend home colon tests It s very easy -- you can do it in the privacy of your home and mail it in We ll make sure the results get to your doctor Reminders After Giving the Kit To Patients Put the kit in the bathroom so it will be there when you need to use it Try to complete the kit in the next week if possible Write the collection dates on each competed kit Mail the kit in as soon as possible after you finish collecting the stool Call us if you have a problem with the kit Talk to your doctor if you have any other questions about FOBT or FIT

3 Patient years of age? No STOP No Action Yes Colonoscopy in last 10 years or FIT/FOBT in last year? Yes STOP No Action No Any rectal bleeding or history of colon cancer or polyps? Yes Refer for Colonoscopy No Healthy enough to have a colonoscopy if FIT is +? No STOP No Action Yes Offer FIT Test for Screening

4 Tracking form for abnormal FIT/FOBT follow-up Patient Name Phone Number Date FOBT Completed Result: pos. or neg. Name of PCP Date PCP Notified Date colonoscopy scheduled Date colonoscopy completed

5 Flu Vaccination Authorization Record and FLU-FIT/FOBT Log This form must be signed by the vaccine recipient or by the parent, guardian, or other authorized person on the date the vaccine is administered. Manufacturer: Lot Number: Expiration Date: Facility Site: I have read or had explained to me the "Influenza Vaccine Information Statement." I have had an opportunity to ask questions which were answered to my satisfaction. I understand the benefits and risks of influenza vaccine and request that it be given to me or to the person for whom I am authorized to make this request. If I am between the ages of 50 and 75 and being offered a FIT/FOBT kit for colorectal cancer screening today, it has been explained to me. Clinic Staff Initials Flu Shot Site Signature FIT/FOBT Eligible FIT/FOBT Age 50-75, Given Patient Name / Phone no FIT/FOBT this year, To Patient and no colonoscopy in 10 yrs Total FLU Shots Given Total FIT/FOBT: Eligible Given

6 Colon Cancer Screening Choices Colonoscopy FIT 1. Can remove polyps to prevent cancer. 2. Can find cancer earlier, when it s easier to treat and cure. 3. If the exam is normal and your cancer risk is average, you only need one every 10 years. 1. A low-cost, no-risk stool test you can do at home. 2. Finds 70-80% of cancers. 3. A good choice if you can t have a colonoscopy. Things to Think About 1. You need to use laxatives to clean your bowels and have IV sedation during the exam. 2. You need to take a day off work and have a driver take you home. 1. If your FIT result is not normal you will need a follow-up colonoscopy. 2. A FIT exam must be done every year to work as good as colonoscopy. 3. Most insurance plans will pay for this test, but if you don t have insurance it can be expensive. The Bottom Line Colon cancer is the #2 cancer killer among men and women combined. But, with regular testing using colonoscopy or FIT you can find colon cancer earlier and greatly improve your chance of survival.

7 Opciones para la detección del cáncer de colon Colonoscopia FIT Beneficios 1. Puede eliminar pólipos para prevenir el cáncer. 2. Puede detectar el cáncer temprano, cuando es más fácil de tratar y curar. 3. Si el examen es normal y el riesgo de cáncer es promedio, sólo se necesita un examen cada 10 años. 1. Un examen de materia fecal de bajo costo y sin riesgo, que puede hacer en casa. 2. Detecta el 70-80% de los cánceres. 3. Una buena opción si no puede tener una colonoscopia. Cosas que Debe Considerar 1. Es necesario utilizar laxantes para limpiar los intestinos y tener sedación intravenosa durante el examen. 2. Es necesario tomar un día libre del trabajo y tener un conductor que lo lleve a casa. 1. Si los resultados de su examen FIT no son normales, tendra que hacerse una reexaminación de colonoscopia. 2. Debe hacerse un examen FIT cada año para que sea tan eficaz como la colonoscopia. 3. La mayoría de los planes de seguro pagan por este examen, pero si usted no tiene seguro, puede ser costoso. El Punto Final El cáncer de colon es el segundo cáncer más común entre hombres y mujeres. Sin embargo, usando pruebas regulares como la colonoscopia o FIT el cáncer de colon se puede detectar más temprano y mejorar sus posibilidades de sobrevivir. Project supported by the Nevada State Health Division Grant NU58DP

8 Guidelines from the American Cancer Society, the US Preventive Services Task Force, and others recommend Fecal Immunochemical Tests (FIT), High-Sensitivity Fecal Occult Blood Tests (HS-gFOBT) and FIT-DNA testing as options for colorectal cancer (CRC) screening in men and women at average risk for developing colorectal cancer. This document provides stateof-the-science information about these tests. Clinician s Reference STOOL-BASED TESTS FOR COLORECTAL CANCER SCREENING The number of colorectal cancer cases is dropping thanks to screening. We are helping save lives. We can save more.

9 The following factors make stool tests a good option for colorectal cancer screening Colorectal cancer screening with guaiac-based FOBT has been shown to decrease both incidence and mortality in randomized controlled trials. Modeling studies suggest that lives saved through a high quality stool-based screening program are nearly the same as with a high quality colonoscopybased screening program when screening and needed follow up occurs at recommended intervals over a lifetime. 1 IMPLEMENTING HIGH QUALITY STOOL-BASED SCREENING PROGRAMS Use stool tests only for average risk patients (no personal or family history of CRC, adenomas, or genetic syndromes). High risk patients should have colonoscopy screening. Use only high-sensitivity fecal immunochemical (FIT), guaiac-based FOBTs (such as Hemoccult II Sensa), or FIT-DNA tests. Hemoccult II and generic guaiac-based tests are far less sensitive and should not be used for CRC screening. All patients should be aware that stool tests are a recommended screening option, along with invasive exams like colonoscopy. When given a choice, a significant number of patients prefer stool tests. In addition, access to colonoscopy and other invasive tests may be limited or non-existent for many patients. 2 Stool samples obtained by digital rectal exam (DRE) have low sensitivity for cancer (missing 19 of 21 cancers in one study with guaic-based FOBT) and should never be used for CRC screening. All patients who have an abnormal stool test must follow up with colonoscopy. Use reminder and recall systems for health care providers and EHRs to improve the delivery of CRC screening. High senditivity gfobt and FIT should be repeated annually; FIT-DNA tests should be repeated every 3 years based on the manufacturer s recommendation.

10 Three types of stool tests are available FIT, guaiac-based FOBT, and FIT-DNA Fecal Immunochemical Tests (FITs) look for hidden blood in the stool and are specific for human blood while older guaiac-based tests (gfobts) are not. Unlike gfobt, FIT results are not impacted by food or medication. There is evidence that patient adherence with FIT may be higher than with gfobt possibly because no dietary and medication restrictions are required before collecting samples, or because some brands of FIT require collection of only 1 or 2 specimens for a completed test. It is important to note that not all FITs are equally effective. As of July 2016, there are 26 FDA-cleared FITs available for purchase in the US, however most do not have published data on their performance for detection of cancer. To assist with choosing a FIT for use in your setting, the table below includes FITs that have published data on sensitivity and specificity for cancer. FIT BRAND NAME Automated (non-clia waived) FITs MANUFACTURER SENSITIVITY FOR CANCER, SPECIFICITY FOR CANCER, NUMBER OF STOOL SAMPLES OC Auto-FIT* Polymedco 65%-92.3% 3,4 87.2%-95.5% 3,4 1 CLIA-waived FITs OC-Light ifob Test (also called OC Light S FIT) Polymedco 78.6%-97.0% 3,4 88.0%-92.8% 3,4 1 QuickVue ifob Quidel 91.9% % 5 1 Hemosure One-Step ifob Test Hemosure, Inc. 54.5% %3 1 or 2 InSure FIT Clinical Genomics 75.0%6 96.6%6 2 Hemoccult-ICT Beckman Coulter 23.2%-81.8% %-96.9% 3 2 or 3 *Used with OC-Sensor DIANA and OC-Auto Micro 80 automated analyzers. Detection limits for cancer vary across FIT brand and by study such that direct comparison between FIT brands is not possible. Cited studies should be interpreted in the full context of the published literature given variation in study size and quality. Guaiac-based FOBTs (gfobts) have been the most common form of stool tests used in the US prior to FIT becoming widely available. Modern high-sensitivity tests have much higher cancer and adenoma detection rates than older tests, resulting in fewer missed cancers. Hemoccult II SENSA is the only test in this category for which published performance data is available. Screening guidelines now specify that only high-sensitivity forms of guaiac-based tests should be used for colorectal cancer screening. Hemoccult II and similar older guaiac-based tests should not be used for colorectal cancer screening. GFOBT BRAND NAME MANUFACTURER SENSITIVITY FOR CANCER SPECIFICITY FOR CANCER NUMBER OF STOOL SAMPLES Hemoccult II SENSA Beckman Coulter 61.5%-79.4% %-96.4% 4 3 FIT-DNA is a stool DNA test looks for mutations associated with cancer and adenomas that are sometimes found in colon and rectal cells excreted in the stool. Cologuard is the only stool DNA test currently marketed in the US and combines testing for DNA markers with a high-quality FIT ( a FIT-DNA test). FIT-DNA BRAND NAME MANUFACTURER SENSITIVITY FOR CANCER SPECIFICITY FOR CANCER NUMBER OF STOOL SAMPLES Cologuard Exact Sciences 92.3% % 7 1* *Requires collection of an entire bowel movement.

11 Key Sources 1. Inadomi JM, Vijan S, Janz NK, Fagerlin A, Thomas JP, Lin YV, Muñoz R, Lau C, Somsouk M, El-Nachef N, Hayward RA. Adherence to Colorectal Cancer Screening: A Randomized Clinical Trial of Competing Strategies. Arch Intern Med. 2012;172(7): US Preventive Services Task Force. Screening for Colorectal Cancer US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23): Daly JM, XU Y, Levy BT. Which Fecal Immunochemical Test Should I Choose? J Prim Care Community Health Apr 1: doi: / [Epub ahead of print] 4. Lin JS, Piper MA, Perdue LA, Rutter C, Webber EM, O Connor E, Smith N, Whitlock EP. Screening for Colorectal Cancer: A Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No AHRQ Publication No EF-1. Rockville, MD: Agency for Healthcare Research and Quality; Tao S, Seiler CM, Ronellenfitsch U, Brenner H. Comparative evaluation of nine faecal immunochemical tests for the detection of colorectal cancer. Acta Oncologica. Vol. 52, Iss. 8, Smith A, Young GP, Cole SR, Bampton P. Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based fecal occult blood test in detection of colorectal neoplasia. Cancer. 107: Other Information Sources Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. N Engl J Med. 2014;370: American Cancer Society. Colorectal Cancer Facts & Figures Atlanta: American Cancer Society; www. cancer.org/content/dam/cancer-org/research/cancerfacts-and-statistics/colorectal-cancer-facts-and-figures/ colorectal-cancer-facts-and-figures pdf. Accessed 8 September Smith RA, Andrews KS, Brooks D, Fedewa SA, ManassaramBaptiste D, Saslow D, Brawley OW, Wender RC. Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening. CA: A Cancer Journal for Clinicians, 67: Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology Apr;152(5): e3. Akram A, Juang D, Bustamante R, Liu L, Earles A, Ho SB, Wang-Rodriguez J, Allison JE, Gupta S. Replacing the Guaiac Fecal Occult Blood Test With the Fecal Immunochemical Test Increases Proportion of Individuals Screened in a Large Healthcare Setting. Clin Gastroenterol Hepatol Aug;15(8): e1. Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: The FIT Revolution. Dig Dis Sci. 60(3): Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of Fecal Immunochemical Tests for Colorectal Cancer: Systematic Review and Meta-analysis. Ann Intern Med Feb 4;160(3):171. Collins JF, Lieberman DA, Durbin TE, Weiss DG; Veterans Affairs Cooperative Study #380 Group. Accuracy of Screening for Fecal Occult Blood on a Single Stool Sample Obtained by Digital Rectal Examination: A Comparison with Recommended Sampling Practice. Ann Intern Med. 2005;142: Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative Effectiveness of Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal Cancer Screening Among the Underserved: A Randomized Clinical Trial. JAMA Intern Med. 2013;173(18): Washington State Department of Health. Offer FIT as an Option to Boost Colorectal Cancer Screening here.doh.wa.gov/ materials/fit/13_fitfactsht_e13l.pdf. Accessed 8 September Visit nccrt.org or cancer.org/colonmd to find additional clinical practice tools and learn more about 80% by View the NCCRT June 2016 Implementing FIT webinar: cancer.org American Cancer Society, Inc. Models used for illustrative purposes only.