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Recommendations for Preventing Cancer and Finding It Early: Prostate and Colorectal UCAN Conference May 14, 2015 Durado Brooks, MD, MPH Director, Prostate and Colorectal Cancers American Cancer Society Prostate Cancer 2 USPSTF Recommendation on PCA Screening with PSA (May 2012) “The U.S. Preventive Services Task Force (USPSTF) recommends against prostate-specific antigen (PSA)-based screening for prostate cancer... This recommendation applies to men in the U.S. population that do not have symptoms that are highly suspicious for prostate cancer, regardless of age, race, or family history. “ Guidelines from other organizations Organization Recommendation American Cancer Society (2010) Shared Decision Making National Comprehensive Cancer Network (2010) Shared Decision Making American Society of Clinical Oncology (2012) Shared Decision Making American Urological Association (2013) Shared Decision Making What’s Different about Prostate Screening? Compared to other recommended cancer screenings: • Less scientific evidence that prostate cancer screening saves lives – Breast Cancer: 9 studies show mammograpy lowers deaths – Prostate Cancer: 2 positive studies, and 1 in which screening did not lower the risk of dying from prostate cancer Studies did not include significant numbers of African American or other high risk men • Available tests are less accurate – False positives and false negatives very common • More evidence of – Overdiagnosis (~1 out of every 4 cases in African Americans) – Major treatment side effects and complications – Overtreatment (one-third to one-half of all treated men would likely do well without treatment) . Limitations/Harms False negative results PSA and DRE “normal”, but cancer is present May lead to false reassurance and delayed diagnosis Research has shown that no PSA level can completely rule-out cancer Prostate Cancer Prevention Trial found cancer in significant proportion of men with “normal” PSA level False Negative Results Prostate Ca in Men with PSA < 4.0ng/ml in the Prostate Cancer Prevention Trial 30 27 24 25 % with Prostate Cancers (n=2956) 20 17 15 10 10 7 5 0 <0.6 0.6 - 1 1.1 - 2 2.1 - 3 PSA Level (ng/ml) Adapted from Thompson I. N Engl J Med 2004;350:2239-46 3.1 - 4 False Negative PSA 4.0+ <4.0 PSA 4+ 7.6% Positive biopsy 25% High grade 19% “Normal” PSA 92.4% Positive biopsy 15% High grade 15% PSA Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data False Negative – Population Level 4.0+ <4.0 Screen 10,000 Men PSA 4+ Positive biopsy High grade 7.6% 25% 19% “Normal” PSA 92.4% Positive biopsy 15% High grade 15% PSA 4+ Cancer High grade 760 190 36 PSA <4 9240 Cancer 1386 High grade 208 PSA Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data False Positive Results If 100 men in each age group are tested: Age (in years) # With PSA > 4.0* 50s 5 1–2 3–4 60s 15 3–5 10–12 70s 27 9 18 # With Cancer # False Positives *Lowering the threshold PSA (e.g. to 2.5 ng/ml) will increase false positives and resulting biopsies False Positive PSA False positive results may lead to: • Anxiety and fear of a cancer diagnosis • Additional tests, with associated costs and risk of complications • Insurance implications* “pre-existing condition” exclusions for health insurance Life insurance - high rates or uninsurable *A prostate cancer diagnosis carries similar implications Overdiagnosis Risk of Pca Diagnosis & Death during the next 15 years (per 1000 men ) Age 50 Race/Ethnicity Diagnosis Age 65 Death Diagnosis Death All 50 2 117 16 White 44 2 113 14 African American 76 5 163 34 . Treatment Risks/Harms Estimates from USPSTF review: •90% • of diagnosed men choose active treatment 195,000 men each year 38% radiation 40% prostatectomy •5/1000 men die within 30 day of prostatectomy •200-300/1000 treated men experience impotence, incontinence or both These complications may be a worthwhile trade-off for men whose lives are saved by treatment, but it is not clear how many men fall into this category. Balance of Benefits and Harms Potential Benefits Potential Harms PSA screening detects cancers earlier. False negatives and false positives are common. Treating PSA-detected cancers may be more effective, but this is uncertain. Overdiagnosis and overtreatment are problems, but the magnitude is uncertain. PSA may contribute to the declining death rate, but the extent is unclear Treatment-related complications and side effects can be significant. ACS Guideline for the Early Detection of Prostate Cancer The American Cancer Society recommends that asymptomatic men who have at least a 10-year life expectancy have an opportunity to make an informed decision with their health care provider about whether to be screened for prostate cancer, after receiving information about the uncertainties, risks, and potential benefits associated with prostate cancer screening. Source: Wolf, et al. CA, 2010 ACS Guideline Age to start the discussion depends on risk Risk Group Age Average (with life expectancy 10 years or more*) 50 Increased (African American or family history) 45 Highest (multiple family members) 40 *Men who have less than 10 year life expectancy (due to age or health problems) should not be screened ACS Guideline: Emphasis on Informed Decision Making Core elements of IDM discussion: – Screening increases the chance of finding prostate cancer at an earlier stage – Screening might lower a man’s risk of dying from prostate cancer – but this is not entirely clear – Screening gives many false negative and false positive results – Overdiagnosis and overtreatment are common African American and men with PCa family hx should be informed of their increased risk ACS Decision Aids Decision Aids: Values and Preferences ACS Guideline: Supporting Materials and Information • Materials for clinicians and patients are available at www.cancer.org/prostatemd – Patient Decision Aid “Should I Be Tested for Prostate Cancer” – Brochure “What You Should Know About Prostate Cancer Testing” – Links to videos for patients and clinicians – Prostate Cancer Fact Sheet – Cancer Facts for Men – Links to decision aids from other organizations Research Needs New screening paradigms Identifying higher risk men at earlier age New screening and diagnostic tools Detect men at risk of significant cancers Detect cancers but not benign disease Distinguish aggressive, dangerous prostate cancers from slow-growing, low risk forms New Treatments lower risk of complications, side effects Research Needs Optimal approaches to informed decisionmaking Screening Treatment Appropriate use of active surveillance Evaluation of AS factors and outcomes in African American men High quality treatment for all who choose to be treated Treatment disparities for African American men well-documented Potential for improved access and outcomes through ACA, health system restructuring Colorectal Cancer 23 Colorectal Cancer (CRC) • 3rd most common cancer and the 2nd deadliest in the U.S. • 132,700 new cases in US in 2015 • More than 49,000 deaths • Incidence and death rates falling steadily over the past 20 years • Treatment advances • Screening --> prevention and early detection Colorectal Cancer Incidence, 1980-2008 Incidence Rate per 100,000 Utah DOH Colorectal Cancer Mortality, 1980-2008 Age Adjusted Mortality Rate per 100,000 Utah DOH Colorectal Cancer Deaths by Race, Utah Utah DOH Age: the most impactful risk factor CRC usually develops after age 50. The chances of getting it increases as you get older. http://science.education.nih.gov/supplements/nih1/cancer /guide/pdfs/ACT3M.PDF. CRC screening should begin at age 50 for most people, earlier for those with a family history. 28 Why Screen for CRC? There are two aims of screening: 1. Prevention 2. Early Detection Find and remove polyps to prevent cancer Find cancer in the early stages, when best chance for a cure Risk factor - polyps Different types of polyps: Hyperplastic Low risk: very small chance they’ll grow into cancer Adenomas About 9 out of 10 colon and rectal cancers start as adenomas Usually takes 10 or more years for polyp to become cancer Benefits of Screening Survival Rates by Disease Stage* 5-yr Survival 100 90 80 70 60 50 40 30 20 10 0 89.8% 67.7% 10.3% Lo cal Reg io n al Distan t St age of Det ect ion *1996 - 2003 CRC mortality under 2 screening scenarios 80% screening rate by 2018 yields: • 43,000 averted cases and 21,000 averted cancer deaths/yr • 277,000 cases averted and 203,000 total averted deaths from 2013 through 2030 80% Colon Cancer Screening Rate By 2018 http://nccrt.org/tools/80-percent-by-2018/ http://nccrt.org/tools/80-percent-by-2018/ Recommended Screening Tests ACS and USPSTF Colonoscopy High Sensitivity Fecal Occult Blood Testing Guaiac Immunochemical Flexible Sigmoidoscopy (FSIG) Recent studies support efficacy Availability extremely limited in U.S. CRC Screening: National Rates In 2012, 65.1% of US adults were up to date with screening. • The percentages of blacks and whites up-to-date with screening were equivalent. • Lower rates for Hispanics and Native Americans • Lowest rates among the uninsured CRC Screening: Utah In 2012, 70.2% of Utah adults were up to date with screening. • Significant differences by race/ethnicity, as well as by education and income CRC Screening by Race, Utah 2012-2013 Utah DOH ©2010 American Cancer Society, Inc. No.0052.19 CRC Screening by Ethnicity, Utah 2012-2013 Utah DOH ©2010 American Cancer Society, Inc. No.0052.19 CRC Screening by Education, Utah 2012-2013 Utah DOH ©2010 American Cancer Society, Inc. No.0052.19 CRC Screening by Education, Utah 2012-2013 Utah DOH ©2010 American Cancer Society, Inc. No.0052.19 What’s the Problem? • Medical practice is demand (patient) driven • Practice demands are numerous/diverse • Few practices currently have mechanisms to assure that every eligible patient gets an appropriate recommendation for screening. • Opportunistic vs organized screening ©2009 American Cancer Society, Inc. No.0052.19 “Action Plan” Toolkit Version Eight page guide introduces clinicians and staff to concepts and tools provided in the full Toolkit Contains links to the full Toolkit, tools and resources Not colorectal-specific; practical, action-oriented assistance that can be used in the office to improve screening rates for multiple cancer sites (colorectal, breast and cervical) Available at http://nccrt.org/about/providereducation/crc-clinician-guide/ Staff Involvement • Key Point…..the clinicians cannot do it all! • Time that patients spend with non-clinician staff is underutilized • Standing orders can empower nurses, intake staff, etc. to distribute educational materials, schedule appointments, etc. • Involve staff in meetings to discuss progress in achieving office goals for improving the delivery of preventive services Communication http://nccrt.org/about/provider-education/manual-for-community-health-centers-2/ Step #1 Make A Plan Determine Baseline Screening Rates • Identify your patients due for screening • Identify patients who received screening • Calculate the baseline screening rate • Improve the accuracy of the baseline screening rate Design Your Practice's Screening Strategy • Choose a screening method • Use a high sensitivity stoolbased test • Understand insurance complexities. • Calculate the clinic's need for colonoscopy • Consider a direct endoscopy referral system Step #2 Assemble A Team Form An Internal CHC Leadership Team • Identify an internal champion • Define roles of internal champions • Utilize patient navigators • Define roles of patient navigators • Agree on team tasks Partner with Colonoscopists • Identify a physician champion Step #3 Get Patients Screened Prepare The Clinic • Conduct a risk assessment Prepare The Patient • Provide patient education materials Step #4 Coordinate Care Across The Continuum Coordinate Follow-Up After Colonoscopy • Establish a medical neighborhood Make A Recommendation • Convince reluctant patients to get screened Ensure Quality Screening for StoolBased Screening Program Track Return Rates and Follow-Up Measure and Improve Performance 49 http://nccrt.org Who’s Not Screened? 51 Address Potential Barriers to Screening* #1: Affordability #2: Lack of symptoms #3: No family history of colon cancer • “I do not have health insurance and would not be able to afford this test. I do not feel the need to have it done.” • “Doctors are seen when the symptoms are evidently presumed, not before.” • “Never had any problems and my family had no problems, so felt it wasn't really necessary.” *Based on 2014 consumer surveys #1 reason among 50-64 year olds & Hispanics Nearly ½ uninsured #1 reason among 65+ year olds Address Potential Barriers to Screening* #4: Perceptions about the unpleasantness of the test • “I do not think it is a good idea to stick something where the sun don’t shine. The yellow Gatorade I cannot stomach.” #5: Doctor did not recommend it • “I fear it will be uncomfortable. My doctor has never mentioned it to me, so I just let it go.” #6: Priority of other health issues • “I just turned 50 and I am dealing with another health issue, so it's on the back burner.” *Based on 2014 consumer surveys #1 reason among Black/African Americans; #3 reason among Hispanics 53 Activating Messages that Motivate Most successful communications campaigns relay 3 messages to allow consumers to comprehend what is being asked to motivate action. We recommend utilizing these messages, or similar messaging, to educate your constituents around options to help achieve our goal. There are several screening options available, including simple take home options. Talk to your doctor about getting screened. Colon cancer is the second leading cause of cancer deaths in the U.S., when men and women are combined, yet it can be prevented or detected at an early stage. Preventing colon cancer, or finding it early, doesn’t have to be expensive. There are simple, affordable tests available. Get screened! Call your doctor today. High Quality Stool Testing Clinicians Reference: FOBT One page document designed to educate clinicians about important elements of colorectal cancer screening using fecal occult blood tests (FOBT). Provides state-of-the-science information about guaiac and immunochemical FOBT, test performance and characteristics of high quality screening programs. Available at www.cancer.org/colonmd New CDC Resource A new CDC-sponsored program to provide guidance and tools for clinicians on the best ways to implement screening for colorectal cancer. Two versions: one for primary care providers and one for clinicians who perform colonoscopy procedures. Continuing education credits are available at no cost for physicians, nurses, and other health professionals. http://www.cdc.gov/cancer/colorectal/quality www.cancer.org/colonmd www.cancer.org/professionals Cancer Resource Network The American Cancer Society is available 24 hours a day, 7 days a week, to help guide you through every step of a cancer experience. 1-800-227-2345 cancer.org Easy to understand information to help you make decisions about your care. Referral for day-to-day questions such as financial, insurance, transportation, and lodging. Connection to others who have been there for emotional support.