TriHealth Cancer Institute, Cincinnati, OH; OhioHealth, Columbus, OH;

1. Genetic Counseling Referrals among Cancer Registry Patients Meeting NCCN Guidelines: An Ohio Study Lindsey Byrne, MS LGC Karen Huelsman, MS, LGC, Nichole A. Morman, MS, LGC, Kate Shane, MS, LGC, Elayna Freese, CTR Karen Smith, RHIA, CTR, Laura L. Vondenhuevel, RHIT, CTR, Maria Teresa Ramirez, CTR, Anna Starr BS TriHealth Cancer Institute, Cincinnati, OH; OhioHealth, Columbus, OH; The Ohio State University James Cancer Center, Columbus, OH; Mount Carmel Health, Columbus, OH; CHAMPS Oncology, Columbus, OH Ohio Department of Health

2. Objectives • Explain genetic counseling, genetics, and hereditary cancer • Discuss our Ohio Genetic Counseling study and collaboration with registry data • Identify interventions and the future of our study through the National Comprehensive Cancer Network (NCCN) guidelines

3. Genetic Counseling, Genetics, and Hereditary Cancer

4. What is a Licensed Cancer Genetic Counselor (LGC)? Health care professionals with a specialized graduate degree in the areas of medical genetics and counseling Calculate a cancer risk analysis from acquired personal and family histories Provide in-depth counseling and education about cancer genetics, hereditary cancer, and genetic testing Offer a course of action for managing cancer risk that seems personally appropriate (genetic testing, screening or long-term follow up) Order and interpret genetic tests Address complex psychosocial issues Facilitate entry into research studies

7. Most cancers are not hereditary 5-10% hereditary 10-15% familial 75-85% sporadic

8. Basic Genetics Slide Courtesy Greenwood Genetics

9. DNA and mutations • Example • Normal DNA THE DOG RAN OUT • DNA mutation THE TTD OGR ANO UT • DNA mutation TAE DOG RAN OUT • DNA mutation THE OGR ANO UT_ A→T G→C

11. Our Study!

12. Cancer Genetics

13. Objective 15: Cancer Genetics By December 31, 2020, increase the overall number of individuals who receive Ohio Cancer Genetic Network (OCGN) Cancer Risk Assessment services. • Baseline 4,590 Target 5,508 • We have 11,758 • Ohio Cancer Risk Assessment Services-Ohio healthcare facilities that provide cancer risk assessment and counseling services by licensed genetic counselors specializing in cancer genetic counseling

14. Objective 15: Cancer Genetics Strategies Promote collaboration between cancer genetic counselors and hospital registries to identify patients and families appropriate for genetic counseling. • Baseline 3 Hospitals Target 8 Hospitals

15. Study Rationale To help meet the OPCC’s state cancer plan objective To establish a statewide benchmark for OCGN centers by analyzing referral data for patients meeting NCCN criteria identified by hospital cancer registries at four OCGN centers.

16. Background • NCI estimates >460,000 patients diagnosed with breast, colon, endometrial, ovarian cancer in 2017. • About 10% of cancers are hereditary, and identification of individuals with these syndromes can impact future health by: • Altering screening recommendations • Determining risk for additional cancers • Offering preventative therapies • Potentially impacting treatment options • NCCN criteria for Genetic Counseling referral • Since 2005, United States Preventive Services Task Force (USPSTF) recommends women at high risk be referred for genetic counseling • Michigan study: 90% of women with breast cancer <50 did not receive genetic counseling. (1) Michigan and Oregon use cancer registry data to identify patients with possible hereditary breast/ovarian cancer (2) • Fussman, C.; Mange, S. Breast and ovarian cancer family history genetic counseling among Michigan women. Mich. BRFSS Surveill. Brief 2013, 7,5. • (Trivers KF. The Activities and Impact of State Programs to Address Hereditary Breast Ovarian Cancer, 2011-2014

17. Participating Sites in Ohio Nichole Morman Kate Shane Karen Huelsman Lindsey Byrne Elayna Freese Karen Smith Laura Vondenhuevel *CHAMPS Oncology . • MariaTeresa Ramirez With support from Anna Starr, Ohio Department of Health

18. SpecificAims Aim 1. Determine number of patients eligible for genetic counseling referral among cancer registry patients meeting following criteria: • Diagnosed with female breast cancer between ages 18-49; • Diagnosed with female triple negative breast cancer between ages 50-60; • Diagnosed with male breast cancer at age 18 or greater; • Diagnosed with endometrial cancer between ages 18-49; • Diagnosed with fallopian tube/ovarian/primary peritoneal cancer at age 18 or greater; • Diagnosed with colorectal cancer between ages 18-49; • Diagnosed with endometrial cancer at age 50 or greater with abnormal tumor screening for Lynch syndrome; • Diagnosed with colorectal cancer at age 50 or greater with abnormal tumor screening for Lynch syndrome; • Diagnosed with multiple primary cancers Aim 2. Evaluate and compare the methods that were utilized for referral to genetic counseling and the uptake of genetic counseling services among the populations described above. Aim 3. Establish a benchmark for referral and uptake of genetic counseling services for OCGN participating centers.

19. NCCN Criteria for Genetic Referral DATA REQUESTED FROM CANCER REGISTRY Female Breast cancer diagnosed under age 50 Colorectal cancer diagnosed under age 50 (or over 50 with abnormal IHC on tumor) Female Breast triple negative diagnosed 60 and under Endometrial cancer under age 50 (or over 50 with abnormal IHC on tumor) Male Breast cancer diagnosed any age Fallopian tube/ovarian/primary peritoneal cancer diagnosed at any age. Numerous other criterion for genetic counseling referral incorporate personal cancer and family cancer history, requires healthcare provider to gather additional information to determine patient is appropriate for genetic counseling. The criteria above are solely based on the patient’s cancer and age at diagnosis; easiest patients to identify.

22. Methods Calculate Proportionsand compare across locations as aggregate data Request Registry Data4 centers Population Diagnosed 2013-2020 Determine Patients Seen with EMR tracking or genetics database (Progeny) Evaluation Reasons not seen for QA.

23. Study Variables and Outcomes: Demographics Gender GENDER NAME Name* Date of Birth (DOB) DOB MEDICAL RECORD# Medical Record Number (MRN) These identifiers not shared outside local center, only aggregate data sent to OCGN centers.

24. Study Variables and Outcomes: Medical History Type of Cancer CANCER TYPE AGE AT DIAGNOSIS Age at Diagnosis Triple Negative histology female breast TRIPLE NEGATIVE IHC LYNCH IHC tumor screening for Lynch syndrome in colorectal and endometrial cancers

25. Study Variables and Outcomes: Referral and Uptake Factors Epic Referral and Appointment Tracking Referring Provider/Specialty EPIC REFERRAL CANCER TYPE AGE AT DIAGNOSIS • Exclusions- reasons patients not seen • Pathology unlikely inherited • Patient demise or declines visit • Delay in uptake after referral EXCLUSIONS UPTAKE FACTORS IHC LYNCH • Factors that increase uptake • Schedule during infusion or other appt. • Best practice alerts added Epic • Education on NCCN guidelines

26. Study Outcomes Identifiable Factors- Why Patient Came or Not? Did the Patient Have a Genetics Appointment? What are Benchmarks & How Can We Improve? Did the Patient Get Referred?

27. Study Design Continuous, prospective, multi-center, Ohio-wide Compared successive years to quantify quality improvement Discern possible reason for lack of genetic service Calculations % eligible patients referred = Number of Patients Referred to Genetic Counseling Number of Eligible Patients % eligible patients seen = Number of Patients Seen for Genetic Counseling Number of Eligible Patients % referred patients seen = Number of Patients Seen for Genetic Counseling Number of Referred Patients

28. Results Volume Varies by Cancer 2013-2016 data combined all 4 centers

29. Results Referred for GC vs not Referred 2013-2016 data combined all 4 centers

30. Results 5,364 patients from 2013-2016 met NCCN genetic counseling criteria Overall referral rate increased from 18.5% in 2013 to 61.4% in 2016 Breast was the highest referral rate at 51.4%, ovarian 34.4%, colorectal 25.9%, endometrial 20.9%

31. Proportion of Eligible Patients Referred and Seen for Genetic Counseling2016 combined data Referred for GC Seen for GC %

32. Volume Varies by Location Breast Cancer under 50 n=patients #patients Year

33. Proportion of Eligible Seen for GeneticsBreast Cancer under 50 % Year

34. Volume Varies by Location Ovarian Like Cancer (includes ovarian, primary peritoneal, Fallopian) n=patients #patients Year

35. Proportion of Eligible Seen for Genetics Ovarian Like Cancer % Year

36. Proportion of Eligible Patients Not Referred2013-2016 combined data

37. Proportion of Eligible Patients Not Referred 2016 data

38. Conclusions Needs Identified Although we have seen continued improvement, the majority of patients with cancers who meet NCCN guidelines for genetic referral are not being seen. 57.3% overall and 38.6% in 2016. Site Specific Trends Referrals are historically best for breast cancer but the largest improvements have been in colon and Gyn. Improvements Seen across all cancers measurable over time. Benchmarking Collaboration with other Ohio centers allows benchmark, and we hope this study can serve as a point of reference to improve genetic counseling referrals Partnership Importance of cancer registry data and collaboration with cancer registry

39. Partnership with Cancer Registry Cancer Registry provides valuable data that can be applied to identify high risk patients, monitor uptake, and improve the quality of care for cancer patients with the ultimate goal of Precision Medicine. Certification Treatment Research Public Health Cancer Registry Cancer Prevention Genetic Risk Assessment and QA Precision Medicine

40. Lessons Learned for Future of Study How clean is our data? • Are all the hospitals getting the same data points? • Are the same patients being counted at different hospitals locally? • Working to tighten up data with registry to lessen analysis (non-cancerous included, females in male data)

41. Next Steps Updated protocol to include fifth participating hospital ProMedica from Toledo Updated protocol to include all pancreatic cancers and prostate cancer that is metastatic or greater than or equal to Gleason score 7. -What interventions can we implement to increase referrals? • Education to colleagues, community, etc. • Work with specific groups of physicians (create a referral sheet for offices) • Debunk myths and encourage use of specialists versus direct genetic test ordering Identify way to measure criteria such as family history, Ashkenazi heritage, abnormal IHC colon tumors, these are not always measured in cancer registry. Do we go back and address patients who were not referred from previous years?

42. Acknowledgments Ohio Department Health grant funding to build a collaborative study for state of Ohio Malolan Rajagopalan, MD, Elayna Freese, CTR Mount Carmel Health, Columbus OH Karen Huelsman, MS, LGC, Karen Smith CTR TriHealth Cancer Institute, Cincinnati OH Nichole A. Morman, MS, LGC OhioHealth, Columbus, OH Laura L. Vondenhuevel, RHIT, CTR CHAMPS Oncology, Columbus, OH Kate Shane, MS, LGC, Maria Teresa Ramirez, CTR The Ohio State University James Cancer Center, Columbus, OH; Anna Starr BS Ohio Department of Health