The Center for Cancer Prevention and Treatment 2016 PUBLIC REPORTING OF OUTCOMES

The Center for Cancer Prevention and Treatment 2016 PUBLIC REPORTING OF OUTCOMES

Eliminate Ovarian Cancer Patient Barriers to Compliance with Recommended Cancer Genetic Counseling Cancer Committee 2016 Quality Improvement Study (CoC Std. 4.8) Completed by Sandra Brown, MS, LCGC Reason for Study This Quality Improvement was implemented as a result of the recommendations from the 2015 Study of Quality, Barriers to Adherence to NCCN Guideline Recommendation of Ovarian Cancer Patient Referral for Cancer Genetic Risk Assessment. The purpose of this Quality Improvement was to work towards eliminating the previously identified barriers to undergoing the recommended cancer genetic counseling. Background Ovarian cancer occurs in approximately 1.5% of women in the US population with an average age of diagnosis at 62 years and a 5 year survival rate average of 45% (SEER). While the majority of ovarian cancer is considered sporadic in nature, over 10% of ovarian cancer diagnoses are attributed to germline mutations associated with inherited cancer predisposition syndromes including BRCA1 or BRCA2 associated hereditary breast and ovarian cancer syndrome and hereditary non-polyposis colorectal cancer or Lynch syndrome. In fact, recent studies of ovarian cancer patient populations have confirmed significant germline mutation findings within this population; a 2015 study investigating ovarian cancer referrals to genetic counseling reported that 19% of patients with ovarian cancer tested positive for a BRCA1 or BRCA2 mutation (Ricci et al., 2015). The National Comprehensive Cancer Network (NCCN) version 2.2015 guidelines for Genetic/ Familial High-Risk Assessment: Breast and Ovarian Cancers recommend pre-test and posttest genetic counseling and genetic testing of the BRCA1 and BRCA2 genes for every woman diagnosed with invasive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer due to the risk for a hereditary predisposition to cancer syndrome. Additionally, the NCCN version 2.2015 for Genetic/Familial High Risk Assessment: Colorectal recommends pre-test and post-test genetic counseling and genetic testing of the MLH1, MSH2, PMS2, MSH6, and EPCAM genes for individuals diagnosed with two or more Lynch syndrome associated cancers including ovarian cancer. Both guidelines additionally recommend genetic testing consideration of larger multigene panels, which include the BRCA1, BRCA2, MLH1, MSH2, PMS2, MSH6, EPCAM and other genes, based on the additional personal or family history of any woman diagnosed with invasive ovarian cancer. Several recent studies have investigated the frequency of referrals of ovarian cancer to genetic counseling departments. Petzel et al. (2013) investigated the number of epithelial ovarian cancer patients referred to genetic counseling departments and found that only 19% of ovarian cancer cases in their clinic were referred to genetic counseling. From this analysis, Petzel suggested that there is a definite underidentification of carriers and under-utilization of genetic services by providers and patients. While investigating referrals of breast cancer diagnoses under 40 years of age and ovarian cancer diagnoses to genetic counseling, Powel et al. (2013) found that only 21% of patients with ovarian cancer were referred for a genetic consultation compared to 60% of patients diagnosed with breast cancer. Powel s study clearly represents a lack of acknowledgement for ovarian cancer referrals to genetic counseling compared with breast cancer. Ricci et al. (2015) investigated the referral rate of ovarian patients who attended a medical oncology appointment from 2012-2013 and found that only 31% of ovarian cancer patients were referred for genetic counseling. Further, while investigating the likelihood for positive BRCA 2016 PUBLIC REPORTING OF OUTCOMES 2

mutation carriers in patients with ovarian cancer and a 20-25% estimated BRCA positive risk, Meyer et al. (2010) found that about 31% of patients meeting criteria were referred for a genetic consultation over a 9 year period (referrals ranging from 12% in 1999 to 48% in 2007). Methodology The cases of ovarian, fallopian tube, and primary peritoneal cancers used in this quality improvement study were cases reported through the Cancer Registry department at St. Joseph Hospital. An extensive review of electronic medical records and physician contact for cases not referred for a genetic consultation at St. Joseph Hospital Cancer Genetics department were performed. Also, gynecologic oncology clinicians were contacted and interviewed regarding their perceived reasons for non-referral, delayed referral and patient non-compliance. Data Results The Cancer Registry department reported 79 total ovarian cancer cases diagnosed primarily or recurrent from January 2013 through December 2014; 33 cases were reported in 2013 and 46 cases were reported in 2014. Reported ages of diagnoses ranged from 18 to 88 years with a mean age of diagnosis of 60 years. As expected, mixed subtypes were reported including adenocarcinomas, carcinomas, borderline tumors of low malignant potential, carcinosarcomas, germ cell tumors, and ovarian cancer NOS. The majority of ovarian cancers were reported as adenocarcinoma. Data Analysis In compliance with the 2013 and 2014 NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian Cancer guidelines, 37 of the total 79 ovarian cancer cases were referred for a genetic counseling consultation at St. Joseph Hospital. After extensive review of the electronic medical records, one additional case was discovered to have been referred for genetic counseling at an outside facility and two patients were referred as they were dying. Therefore, we determined that 52% of all ovarian cancer cases were referred for genetic counseling for cancer genetic risk assessment, but that some patients were obviously too close to the end of life at the time of referral. When considered by year, 45% of cases were referred in 2013 while 54% of ovarian cancer cases were referred in 2014. An approximate 10% increase in referral from 2013 to 2014 was noted. When taking histology into account, 67% of epithelial ovarian cancer cases, as reported by registry data, were referred. Of the cases not referred for a genetic consultation/ genetic testing 47% were of epithelial histology and 36% of cases not referred for a genetic consultation/ genetic testing were identified as deceased. When questioning the patient providers, providers reported patient descriptions of feeling overwhelmed, patient desire to wait, patient declined, and lack of emphasis for genetic counseling by providers. Of the total number of ovarian cancer cases referred for a genetic consultation at St. Joseph Hospital, 73% were seen by one of our licensed genetic counselors. Reasons given by referred patients for declining their appointment at the time of contact by the cancer genetics department for appointment scheduling included death, near death or in hospice at the time of contact (19%), patient not feeling well enough or not interested in genetic counseling/testing at this time (45%), or patient did not return our calls regarding their referral (36%). Quality Improvement Action Plan Identified barriers included patient overwhelmed by diagnosis, patient felt too ill to prioritize the appointment and patient undervalued the genetic counseling. The study also noted that a number of referrals were delayed and a significant number of patients were already close to the end of life at the time of referral. Based on the gathered data from this quality improvement study, recommendations for improvement included continued genetic department pathology review and follow up for ovarian cancer diagnoses as well as outreach to patient care providers so that they might address barriers, encourage compliance and impart the importance of cancer genetic risk assessment at diagnosis. In February 2016, the Gynecologic Oncology Program met to outline quality improvement barriers and 2016 PUBLIC REPORTING OF OUTCOMES 3

strategies that could lead to improvement of outcomes, which are summarized below. 1 Created an ovarian cancer diagnosis referral form. 2 Planned to send the referral form to both the treating physician and the referring physician. 3 Created a patient letter to inform patient of genetic counseling recommendation. 4 Determined that Cancer Genetics Program and Gynecologic Oncology Program nurse navigator, staff and physicians work together with individual patients to identify and address barriers, encourage patients to follow-up with their appointment and to ensure that these patients are not lost to follow up. In September 2016, the Gynecologic Oncology Program met to discuss updated observations of barriers and the impact of the improvement strategies described above. 1. Clinic staff, navigator and physicians reported improved dialog with patients regarding the genetic counseling referral and improved patient understanding of value and desire for compliance. 2. A gynecologic oncologist joined the Cancer Genetics Program as an affiliate program physician and attended the quarterly genetics program meetings where the ovarian screening program was reviewed. 3. Cancer Genetics Program reported significant improvement thus far in referrals and patient appointments, reaching ~90% referred, and ~70% seen or scheduled for genetic counseling appointment. Summary of Findings By the end of 2016 we realized the complete success of the quality improvement action plan as we have received referrals for 100% of ovarian cases (n=39). Of those, 4 patients were deceased, 1 patient did not return our calls, 1 patient declined, and 3 patients had genetic counseling at an outside facility. Of the remaining referrals (n=30), 70% (21/30) have completed genetic counseling at the time of this report, 1 declined testing, and 5 (25%) tested positive for a mutation: BRCA1 (x2), BRCA2, RAD51C and MUTYH genes. Of note, the identification of these mutations impacts 108 close relatives. The remaining 9 patients are either scheduled or are considering if they will decline or schedule. Given our success, the Cancer Genetics Program at the Center for Cancer Prevention and Treatment will continue to manage and maintain the quality improvement strategies and will continue to measure and report referral rate and patient compliance. The cancer genetics program and gynecologic oncology program will continue to work closely together to remain at a 100% referral rate and to support ovarian cancer patient understanding of and timely access to genetic counseling. National Benchmark NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment, Breast and Ovarian References http://seer.cancer.gov/statfacts/html/ovary.html Meyer, L.A., Anderson, M.E., Lacour, R.A., Suri, A., Daniels, M.S., Urbauer, D.L., Nogueras- Gonzalez, G.M., Schmeler, K.M., Gershenson, D.M., & Lu, K.H. (2010). Evaluating Women with Ovarian Cancer for BRCA1 and BRCA2 Mutations. Obstetrics & Gynecology, 115, 5, 945-952. Petzel, S.V., Vogel, R.I., Bensend T., Leininger, A., Argenta, P.A., Geller, M.A. (2013). Genetic Risk Assessment for Women with Epithelial Ovarian Cancer: Referral Patterns and Outcomes in a University Gynecologic Oncology Clinic. Journal of Genetic Counseling, 22, 5, 662-673. Powell, C.B., Littell, R., Hoodfar, E., Sinclair, F., Pressman, A. (2013). Does the Diagnosis of Breast or Ovarian Cancer Trigger Referral to Genetic Counseling? International Journal of Gynecological Cancer, 23, 3, 431-436. Ricci, M.T., Sciallero, S., Mammoliti, S., Gismondi, V., Franiuk, M., Bruzzi. P., & Varesco, L. (2015). Referral of Ovarian Cancer Patients for Genetic Counseling by Oncologists: Need for Improvement. Public Health Genomics, 18, 4, 225-233. 2016 PUBLIC REPORTING OF OUTCOMES 4

STANDARD 4.1 2016 PREVENTION PROGRAMS Smoking Cessation Program Identified Community Need This program serves to address the community needs reported in the 2014 St Joseph Hospital Community Needs Assessment, which reported one of the top health concerns to be lack of access to preventative care and it also highlighted the behavior of adult tobacco use in the community. Program Description In March 2013, St. Joseph Hospital initiated a partnership with the Orange County Health Care Agency Tobacco Use Prevention Program (TUPP) to provide free tobacco cessation services to our patients and the community in English, Spanish, and Vietnamese. The Tobacco Cessation Program uses combination therapy that is comprised of a five-session series, which focuses on behavior modification and nicotine replacement therapy, via nicotine patches. Classes are taught by a Tobacco Cessation Specialist, who has been trained in tobacco treatment counseling by the Orange County Health Care Agency. Each class meets for one hour each week for five consecutive weeks and highlights how participants can identify their tobacco triggers, develop personalized coping strategies, manage stress, avoid relapse, and maintain a tobacco-free lifestyle. A six-week supply of nicotine patches is provided to aid participants in their quitting process and lessen the burden of withdrawal symptoms. Classes are available in English, Spanish, and Vietnamese. Class Sessions Start date of 5-week class: February 2, 2016-4 total participants Start date of 5-week class: July 11, 2016-4 total participants Start date of 5-week class: September 12, 2016-10 total participants Start date of 5-week class: November 21, 2016-7 total participants Evidence- based Intervention Smoking Cessation curriculum is based on clinical practice guidelines from Treating Tobacco Use and Dependence (U.S. Department of Health and Human Services, 2008). These guidelines have been established through evidence-based outcomes that combine nicotine replacement therapy and behavioral counseling. Evaluation Evaluation for the cessation program is conducted 30 days, 90 days, and 180 days after the completion of the first cessation class. The 180 day quit rate for the Tobacco Cessation Program is 38%. Participant satisfaction with the cessation program is very high, with 89% responding very satisfied or satisfied. Participants who need additional support after completion of their cessation class can call the tobacco cessation hotline (1-866-NEW-LUNG). The following evaluation tools are used: Intake form collects demographics on participants and their tobacco use 30 day follow-up form 90 day follow-up form 180 day follow-up form Adult satisfaction survey (English, Spanish and Vietnamese) Youth satisfaction survey 2016 PUBLIC REPORTING OF OUTCOMES 5

STANDARD 4.2 SCREENING PROGRAMS 2016 CT Lung Screening Program Identified Community Need According to the 2014 St Joseph Hospital Community Needs Assessment Report, one of the top health concerns was the lack of access to preventative care. In 2015 lung cancer was among the highest disease sites for St. Joseph Cancer Registry. Program Description Lung cancer can be insidious and oftentimes symptoms do not appear until the disease is advanced. Unfortunately, this is often in the later stages of lung cancer, when the chances of a five-year survival rate drop to 2-4%. However, if lung cancer is diagnosed in its earliest stages the cancer is potentially treatable and curable. With the advent of low dose CT scan the landscape of lung cancer screening was altered with studies indicating that low dose CT scan detects many tumors at early stages. In August 2011, the New England Journal published results from the National Lung Screening Trial that showed a 20% improvement in lung cancer survival when smokers were tested with a reduced radiation CT scan. As a result, in February 2015, Centers for Medicare & Medicaid Services (CMS) approved coverage of low dose CT lung screening for high risk patients. The screening is open to high risk individuals in Orange County. High risk individuals are defined as: Between 55 74 years of age Tobacco smoking history of at least 30 pack years, including former and current smokers Current smoker or quit smoking within the last 15 years No symptoms or signs of lung cancer, specifically no bloody sputum CT Lung Screening Results Number of Screenings 83 Number of Abnormal Findings 18 Confirmed Cases of Lung Cancer 2 Follow-Up Following the CT scan, all patients receive written correspondence advising them of the results. An abnormality could be lung related or other findings such as coronary artery calcifications or other suspicious malignancies. If an abnormality is indicated, the patient is advised to see their primary care physician. Each physician receives a copy of the CT scan report and the recommendation for follow-up per Lung Rads. Patients whose initial scan requires immediate evaluation (Lung Rads 3, 4A, and 4B) are presented to the Thoracic Oncology Program multidisciplinary cancer conference, where the patient s CT scans and history are reviewed. Recommendations are communicated to the patient s physician directly either by the nurse navigator or by written communication. Evidence- based Intervention: 1. International Early Lung Cancer Action Project (I-ELCAP) 2. The National Lung Screening Trial (NLST) 3. American College of Radiologist Practice Parameters Standards 4. CMS Guidelines The National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, et al.. Reduced lung-cancer mortality with lowdose computed tomographic screening. N Engl J Med 2011;365:395-409. 2016 PUBLIC REPORTING OF OUTCOMES 6

In 2016, A1:O57 were 1,765 cases accessioned to the St. A1:O57 Hospital Cancer Registry. This includes 1,518 analytic cases, meaning that these cases were initially diagnosed and/or received their first course of treatment at St. Joseph Hospital. There were 668 males and 1097 females. 1097 females. Class Sex Stage Site Group Total Cases Analytic Non Analytic M F 0 I II III IV Unknown N/A ALL SITES 1765 1518 247 668 1097 118 421 302 193 229 84 171 BREAST 444 404 40 1 443 77 152 115 42 14 4 0 LUNG/BRONCHUS-NON SM CELL 154 144 10 77 77 4 39 20 19 60 2 0 PROSTATE 150 103 47 150 0 0 7 66 18 9 3 0 CORPUS UTERI 88 75 13 0 88 0 45 0 6 6 18 0 COLON 83 74 9 35 48 3 15 24 21 6 5 0 THYROID 75 72 3 12 63 0 50 1 4 5 12 0 HEMERETIC 72 52 20 43 29 0 0 2 4 2 1 43 MELANOMA OF SKIN 61 56 5 37 24 8 28 6 4 7 3 0 PANCREAS 57 50 7 32 25 2 4 13 4 27 0 0 NON-HODGKIN'S LYMPHOMA 57 48 9 21 36 0 10 8 10 19 1 0 KIDNEY AND RENAL PELVIS 47 42 5 29 18 1 19 3 4 9 4 2 BLADDER 40 37 3 27 13 17 9 8 0 3 0 0 STOMACH 37 31 6 25 12 1 3 5 3 14 5 0 RECTUM & RECTOSIGMOID 37 33 4 18 19 2 4 3 13 3 8 0 OVARY 35 28 7 0 35 0 7 4 9 5 2 1 LIVER 29 24 5 23 6 0 7 1 7 3 1 5 MYELOMA 28 27 1 13 15 0 0 0 0 0 0 27 BRAIN 28 22 6 18 10 0 0 0 0 0 0 22 CERVIX UTERI 26 20 6 0 26 0 9 6 4 0 1 0 OTHER NERVOUS SYSTEM 23 22 1 8 15 0 0 0 0 0 0 22 UNKNOWN OR ILL-DEFINED 22 20 2 8 14 0 0 0 0 0 0 20 SMALL INTESTINE 13 12 1 8 5 0 1 1 3 7 0 0 SOFT TISSUE 13 11 2 9 4 0 1 3 2 4 1 0 ESOPHAGUS 12 11 1 9 3 1 1 2 1 5 1 0 OTHER ENDOCRINE 12 11 1 9 3 0 0 0 0 0 0 11 TONGUE 11 10 1 8 3 0 2 1 1 5 1 0 HODGKIN'S DISEASE 11 8 3 4 7 0 1 6 1 0 0 0 LUNG/BRONCHUS-SMALL CELL 9 8 1 2 7 0 0 0 5 3 0 0 BILE DUCTS 8 8 0 5 3 0 0 1 0 2 2 3 OTHER HEMATOPOIETIC 8 4 4 4 4 0 0 0 0 0 0 4 UTERUS NOS 8 6 2 0 8 0 3 0 0 2 0 1 VULVA 7 1 6 0 7 0 0 0 0 0 1 0 SALIVARY GLANDS, MAJOR 6 5 1 4 2 0 0 1 2 1 0 1 PERITONEUM,OMENTUM,MESENT 6 6 0 0 6 0 0 0 3 1 1 1 TONSIL 5 5 0 4 1 0 0 0 2 2 1 0 LARYNX 5 4 1 4 1 1 3 0 0 0 0 0 GALLBLADDER 4 3 1 0 4 0 0 0 0 2 1 0 NASAL CAVITY,SINUS,EAR 4 4 0 2 2 0 0 0 0 1 0 3 OTHER SKIN CA 4 2 2 3 1 0 0 0 0 0 0 2 TESTIS 4 2 2 4 0 0 0 0 0 0 2 0 RETROPERITONEUM 3 2 1 1 2 0 0 0 0 2 0 0 BONE 3 1 2 1 2 0 0 0 0 0 1 0 HYPOPHARYNX 2 0 2 2 0 0 0 0 0 0 0 0 ANUS,ANAL CANAL,ANORECTUM 2 2 0 0 2 1 0 0 1 0 0 0 OTHER DIGESTIVE 2 2 0 1 1 0 0 0 0 0 0 2 PLEURA 2 2 0 2 0 0 1 1 0 0 0 0 VAGINA 2 0 2 0 2 0 0 0 0 0 0 0 LIP 1 1 0 1 0 0 0 0 0 0 1 0 OROPHARYNX 1 1 0 1 0 0 0 0 0 0 1 0 OTHER FEMALE GENITAL 1 0 1 0 1 0 0 0 0 0 0 0 PENIS 1 1 0 1 0 0 0 1 0 0 0 0 OTHER URINARY 1 1 0 1 0 0 0 0 0 0 0 1 EYE 1 0 1 1 0 0 0 0 0 0 0 0 2016 PUBLIC REPORTING OF OUTCOMES 7

1000 W. La Veta Avenue Orange, CA 92868 (714) 734-6200 sjo.org/cancer 2016 PUBLIC REPORTING OF OUTCOMES 8