JONS February 2015 Vol 6 No 1 by The Oncology Nurse

February 2015 • Vol 6, NO 1

Development of a Cancer Resource Center in a Rural Texas Border Community Heather Becker, PhD; Willie Braudway; Jill Maughan, MEd; Amanda M. Warfield, BS; Rev. Marvin D. Wood, BS

Patient Experience Mapping: A Quality Improvement Tool for Patient Navigators Heather Kapp, LICSW, MPH; Mandi Pratt-Chapman, MA

Jessica Engel Named ONE Award Winner at AONN+ Conference Clinician and Survivor Shares Perspectives on Cancer Care An Interview with Lillie D. Shockney, RN, BS, MAS

Navigating Patients Across the Continuum of Cancer Caretm

www.AONNonline.org

Introducing the first and FDA-approved treatment

patients with polycythemia vera an inadequate response to or are In a phase 3 trial of Jakafi® (ruxolitinib) vs best available therapy: 21% of patients receiving Jakafi achieved the primary composite end point of hematocrit (Hct) control and spleen volume reduction compared with <1% of patients on best available therapy at week 32 (P < 0.0001)*

Indications and Usage Jakafi is indicated for treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Important Safety Information Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are each dose‐related effects. Perform a pre‐treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi Severe neutropenia (ANC <0.5 X 109/L) was generally reversible by withholding Jakafi until recovery Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly

Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk‐benefit determination Progressive multifocal leukoencephalopathy (PML) has occurred with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate Advise patients about early signs and symptoms of herpes zoster and to seek early treatment When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi‐organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent

only for

who have had intolerant of hydroxyurea

Visit www.jakafi.com/HCP illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations The three most frequent non‐hematologic adverse reactions (incidence >10%) were bruising, dizziness and headache A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or fluconazole or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breast‐feed Please see Brief Summary of Full Prescribing Information for Jakafi on the following page.

to see Full Prescribing Information and learn more about Jakafi for use in PV

* A randomized, open-label, active-controlled phase 3 trial comparing Jakafi with best available therapy in 222 patients. Best available therapy included hydroxyurea (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%). The primary end point was the proportion of subjects achieving a response at week 32, with response defined as having achieved both Hct control (the absence of phlebotomy eligibility beginning at the week 8 visit and continuing through week 32) and spleen volume reduction (a ≥35% reduction from baseline in spleen volume at week 32). Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value). Reference: 1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.

BRIEF SUMMARY: For Full Prescribing Information, see package insert. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2.1.1) and Adverse Reactions (6.1) in Full Prescribing Information]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible by withholding Jakafi until recovery [see Adverse Reactions (6.1)]. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. [see Dosage and Administration (2.1.1) and Adverse Reactions (6.1) in Full Prescribing Information]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Tuberculosis Tuberculosis infection has been reported in patients receiving Jakafi. Observe patients receiving Jakafi for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Jakafi, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Jakafi. The decision to continue Jakafi during treatment of active tuberculosis should be based on the overall risk-benefit determination. PML Progressive multifocal leukoencephalopathy (PML) has occurred with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions (6.1)]. Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi Following discontinuation of Jakafi, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with myelofibrosis have experienced one or more of the following adverse events after discontinuing Jakafi: fever, respiratory distress, hypotension, DIC, or multi-organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Jakafi, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi therapy without consulting their physician. When discontinuing or interrupting therapy with Jakafi for reasons other than thrombocytopenia or neutropenia [see Dosage and Administration (2.5) in Full Prescribing Information], consider tapering the dose of Jakafi gradually rather than discontinuing abruptly. Non-Melanoma Skin Cancer Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Jakafi. Perform periodic skin examinations. ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions (5.1)] • Risk of Infection [see Warnings and Precautions (5.2)] • Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see Warnings and Precautions (5.3)] • Non-Melanoma Skin Cancer [see Warnings and Precautions (5.4)]. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Myelofibrosis The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In patients starting treatment with 15 mg twice daily (pretreatment platelet counts of 100 to 200 X 109/L) and 20 mg twice daily (pretreatment platelet counts greater than 200 X 109/L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy. In a double-blind, randomized, placebocontrolled study of Jakafi, among the 155 patients treated with Jakafi, the most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2 ]. Thrombocytopenia, anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with Jakafi and 11% of patients treated with placebo. Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment. Table 1: Myelofibrosis: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment Jakafi Placebo (N=155) (N=151) Adverse Reactions

a b

c d

e f

All Gradesa Grade 3 (%) (%)

Grade 4 All Grades Grade 3 (%) (%) (%)

Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (<1%) discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 5% of patients receiving Jakafi and to 4% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in <1% of patients receiving Jakafi and <1% of patients receiving control regimens. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (17% versus 7%). Neutropenia In the two Phase 3 clinical studies, 1% of patients reduced or stopped Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebocontrolled study. Table 2: Myelofibrosis: Worst Hematology Laboratory Abnormalities in the Placebo-Controlled Studya Jakafi (N=155) Laboratory Parameter

All Gradesb (%)

Grade 3 (%)

Placebo (N=151) Grade 4 (%)

All Grades (%)

Grade 3 (%)

Grade 4 (%)

Thrombocytopenia

Anemia

Neutropenia

a b

Presented values are worst Grade values regardless of baseline National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Additional Data from the Placebo-controlled Study 25% of patients treated with Jakafi and 7% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 2% for Jakafi with 1% Grade 3 and no Grade 4 ALT elevations. 17% of patients treated with Jakafi and 6% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was <1% for Jakafi with no Grade 3 or 4 AST elevations. 17% of patients treated with Jakafi and <1% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was <1% for Jakafi with no Grade 3 or 4 cholesterol elevations. Clinical Trial Experience in Polycythemia Vera In a randomized, open-label, active-controlled study, 110 patients with polycythemia vera resistant to or intolerant of hydroxyurea received Jakafi and 111 patients received best available therapy [see Clinical Studies (14.2) in Full Prescribing Information]. The most frequent adverse drug reaction was anemia. Table 3 presents the most frequent non-hematologic treatment emergent adverse events occurring up to Week 32. Discontinuation for adverse events, regardless of causality, was observed in 4% of patients treated with Jakafi. Table 3: Polycythemia Vera: Treatment Emergent Adverse Events Occurring in ≥ 6% of Patients on Jakafi in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatment Jakafi (N=110) Adverse Events

Grade 4 (%)

Best Available Therapy (N=111)

All Gradesa (%)

Grade 3-4 (%)

All Grades (%)

Headache

Abdominal Painb

Diarrhea

Dizzinessc

Fatigue

Pruritus

Dyspnead

Muscle Spasms

Nasopharyngitis

Constipation

Cough

Grade 3-4 (%)

Bruisingb

Edemae

Dizzinessc

Arthralgia

Headache

Asthenia

Urinary Tract Infectionsd

Epistaxis

Weight Gaine

Herpes Zosterf

Flatulence

Nausea

Herpes Zosterf

a b

National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 includes abdominal pain, abdominal pain lower, and abdominal pain upper includes dizziness and vertigo includes dyspnea and dyspnea exertional includes edema and peripheral edema includes herpes zoster and post-herpetic neuralgia

National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 c includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site d hematoma, increased tendency to bruise, petechiae, purpura e includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis f includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, Other clinically important treatment emergent adverse events observed in less than 6% of patients bacteria urine identified, nitrite urine present treated with Jakafi were: Weight gain, hypertension, and urinary tract infections includes weight increased, abnormal weight gain Clinically relevant laboratory abnormalities are shown in Table 4. includes herpes zoster and post-herpetic neuralgia

Table 4: Polycythemia Vera: Selected Laboratory Abnormalities in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatmenta Jakafi (N=110) Laboratory Parameter

All Gradesb Grade 3 (%) (%)

Best Available Therapy (N=111) Grade 4 (%)

All Grades (%)

Grade 3 (%)

Grade 4 (%)

Hematology Anemia

Thrombocytopenia

Neutropenia

Chemistry Hypercholesterolemia

Elevated ALT

Elevated AST

Hypertriglyceridemia

a b

Presented values are worst Grade values regardless of baseline National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9. CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib increased 33% and 91%, respectively following concomitant administration with the strong CYP3A4 inhibitor ketoconazole in healthy subjects. Concomitant administration with mild or moderate CYP3A4 inhibitors did not result in an exposure change requiring intervention [see Pharmacokinetics (12.3) in Full Prescribing Information]. When administering Jakafi with strong CYP3A4 inhibitors, consider dose reduction [see Dosage and Administration (2.3) in Full Prescribing Information]. Fluconazole: The AUC of ruxolitinib is predicted to increase by approximately 100% to 300% following concomitant administration with the combined CYP3A4 and CYP2C9 inhibitor fluconazole at doses of 100 mg to 400 mg once daily, respectively [see Pharmacokinetics (12.3) in Full Prescribing Information]. Avoid the concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily [see Dosage and Administration (2.3) in Full Prescribing Information]. CYP3A4 inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, following concomitant administration with the strong CYP3A4 inducer rifampin in healthy subjects. No dose adjustment is recommended; however, monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Pharmacokinetics (12.3) in Full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratogenicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 52% were 65Â years of age and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with myelofibrosis and moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count between 50 X 109/L and 150 X 109/L, a dose reduction is recommended. A dose reduction is also recommended for patients with polycythemia vera and moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min). In all patients with end stage renal disease on dialysis, a dose reduction is recommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Hepatic Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When administering Jakafi to patients with myelofibrosis and any degree of hepatic impairment and with a platelet

count between 50 X 109/L and 150 X 109/L, a dose reduction is recommended. A dose reduction is also recommended for patients with polycythemia vera and hepatic impairment [see Dosage and Administration (2.4) in Full Prescribing Information]. OVERDOSAGE There is no known antidote for overdoses with Jakafi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of ruxolitinib. Jakafi is a registered trademark of Incyte. All rights reserved. U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 8829013 ÂŠ 2011-2014 Incyte Corporation. All rights reserved. Issued: December 2014 RUX-1428

LETTERS FROM LILLIE

Editor-in-Chief

Prepare to Be Inspired Welcome to our first issue of the New Year for the Journal of Oncology Navigation & Survivorship. This issue is filled with information that I am confident you will find inspiring and Lillie D. Shockney, RN, BS, MAS applicable to your work as a navigator. An informative article on the development of a cancer resource center in a Texas border community demonstrates how it is possible to provide cancer resources to patients in rural areas. The navigator in this community conducted an effective needs assessment, joined forces with local stakeholders, and was innovative in how to assess and deliver the resources that patients with cancer need for education and to overcome barriers to care. If you or part of your health system is in a rural area, this approach may serve as a template for you to achieve the same outcomes on behalf of the patients you navigate. There is also a comprehensive article on patient experience mapping. We have been encouraging all navigators to review and document how their patients with cancer move through the healthcare delivery system so that opportunities for improvement can be identified and addressed. Well, that is what The George Washington University Cancer Institute did. The team there examined processes used for transitioning a patient throughout the cancer care continuum, identified gaps in care and inefficiencies in care coordination, and designed a revised flow process. Remember, we cannot manage what we do not measure, and we should never assume that we know how a process is functioning based on what people assume is happening. This is a great example of organizational management, one of the domains you will learn more about as you participate in our upcoming webinars in preparation for taking the first certification exam for oncology nurse navigators. Read a personal story by Staci K. Oertle, ANP-BC, MSN, OCN, as to why she became a nurse and what her experiences through her nursing career have taught her. You may even share similar experiences! It is great to learn more about one of our Academy of Oncology Nurse & Patient Navigators (AONN+) members, and this member has been very active on our Quality, Outcomes, and Performance Improvement Committee as well. Also, hear from Jessica Engel, DNP, FNP-BC, AOCNP, who received the Oncology Nurse Excellence Award at our 2014 AONN+ conference. Her story will inspire you! You will also find in this issue an interview that was conducted with me, and I share where I see the future of cancer care going, the valuable impact navigation can have on this future, and the importance of thinking in innovative ways to address the needs of our future patients with cancer. Last but not least, I am excited to share that we are responding to the outcry from our navigators who are on the West Coast. Coming up this year in May, we will be holding our first regional AONN+ conference in Seattle, WA. If you work or live in that region of the country, I hope you plan to attend. We have been diligently working on a great program, and I am looking forward to it! Take care, stay warm, and keep navigating! With kind regards,

Lillie D. Shockney, RN, BS, MAS Editor-in-Chief

february 2015 • Volume 6, number 1

Lillie D. Shockney, RN, BS, MAS University Distinguished Service Assoc Prof of Breast Cancer, Depts of Surgery and Oncology; Admin Director, The Johns Hopkins Breast Center; Director, Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins; Assoc Prof, JHU School of Medicine, Depts of Surgery, Oncology & Gynecology and Obstetrics; Assoc Prof, JHU School of Nursing shockli@jhmi.edu

Section Editors

Breast Cancer Sharon S. Gentry, RN, MSN, AOCN, CBCN

Breast Health Navigator Novant Health Derrick L. Davis Cancer Center

Cancer Rehabilitation & Survivorship Julie K. Silver, MD Assistant Professor Harvard Medical School

Genetic Counseling

Cristi Radford, MS, CGC Gene Mavens, LLC

Healthcare Disparities Linda Fleisher, PhD, MPH

Asst VP, Office of Health Communications and Health Disparities Asst Prof, Cancer Prevention and Control Fox Chase Cancer Center

Health Promotion and Outreach Iyaad Majed Hasan, DNP, CNP

Director and Nurse Practitioner Survivorship Clinic and Program Cleveland Clinic, Taussig Cancer Center

Patient-Centered Care Mandi Pratt-Chapman, MA Director GW Cancer Institute

Marcy Poletti, RN, MSN

Nursing Operations Supervisor Wake Forest University Baptist Medical Center

Penny Widmaier, RN, MSN Oncology Nurse Navigator Botsford Cancer Center

Prostate Cancer Frank dela Rama, RN, MS, AOCNS

Clinical Nurse Specialist Oncology/Genomics, Cancer Care Clinic Palo Alto Medical Foundation

Thoracic Oncology Pamela Matten, RN, BSN, OCN St. Joseph Hospital

Quality, Outcomes, and Performance Improvement Committee Co-Chairs

Elaine Sein, RN, BSN, OCN, CBCN Danelle Johnston, RN, MSN, OCN, CBCN

Mission Statement

The Journal of Oncology Navi gation & Survivorship (JONS) promotes reliance on evidence-based prac tices in navigating patients with cancer and their caregivers through diagnosis, treatment, and survivorship. JONS also seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

AONNonline.org

A legacy of innovation, partnership, and patient care

Lilly Oncology is committed to making a meaningful difference for patients by answering the complex questions of cancer care. Weâ&#x20AC;&#x2122;re partnering with organizations all over the world to provide valued resources and support. To learn more, visit www.LillyOncology.com.

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february 2015 • Volume 6, number 1

Table of ConTents

february 2015 • Vol 6, NO 1

LETTERS FROM LILLIE

Prepare to Be Inspired Lillie D. Shockney, RN, BS, MAS

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

Staci K. Oertle, ANP-BC, MSN, OCN

NAVIGATION AND SUPPORT PROGRAM DEVELOPMENT

14 Development of a Cancer Resource Center in a Rural Texas Border Community

Heather Becker, PhD; Willie Braudway; Jill Maughan, MEd; Amanda M. Warfield, BS; Rev. Marvin D. Wood, BS QUALITY IMPROVEMENT TOOLS

20 Patient Experience Mapping: A Quality Improvement Tool for Patient Navigators

Heather Kapp, LICSW, MPH; Mandi Pratt-Chapman, MA

ONCOLOGY NURSE EXCELLENCE AWARD

28 Jessica Engel Named ONE Award Winner at AONN+ Conference

PERSPECTIVES ON CANCER CARE

Clinician and Survivor Shares Perspectives on Cancer Care An Interview with Lillie D. Shockney, RN, BS, MAS

CLINICAL TRIAL TRACKER

New Clinical Trials Under Way

LUNG CANCER

Lung Cancers and Stigma: Perception or Reality?

Caroline Kornhauser, MPH; Sarah Quinlan; Nian Hu; Christin Washington; Dawn Zador; Carolyn Messner, DSW, OSW-C, LCSW-R LUNG CANCER SCREENING

Effective Lung Cancer Screening Meg Barbor

Journal of Oncology Navigation & Survivorship, ISSN 2166-0999 (print); ISSN 2166-0980 (online), is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright © 2015 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Oncology Navigation & Survivorship logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DEPARTMENT, Journal of Oncology Navigation & Survivorship (JONS), 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: fevans@the-lynx-group.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher. Publication of an advertisement or other product mentioned in JONS should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the editorial board nor the publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the editorial director.

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

Staci K. Oertle, ANP-BC, MSN, OCN

Nurse Practitioner and Nurse Manager, Medical Outpatient Infusion Center Inspira Health Network, Vineland, NJ

s I embarked on my nursing career more than 25 years ago, I remember having feelings of both excitement and anxiety. I had just graduated with a degree as a registered nurse at 19 years old when I went for my first interview at a local community hospital in southern New Jersey—it was for a position with a medical surgical–oncology unit. I was interviewed by the unit’s nurse manager. She asked me if I had any experience in nursing school with oncology patients, and proceeded to explain how oncology patients and their families require “extra tender-loving care.” Helping patients through treatments could be quite complex and challenging, she told me, explaining that oncology was a specialty and that oncology nurses were, in fact, special: they cared for the mind, body, and soul of their patients, and frequently laughed and cried with patients and their families. I shared with her an experience I had as a student nurse caring for a woman with metastatic breast cancer. I recalled how she looked anorexic and pale, and was in constant pain from bone metastasis. She was frail, and I gave her several injections for pain the few days I cared for her. I remembered how helpless I felt.

Helping patients through treatments could be quite complex and challenging, she told me, explaining that oncology was a specialty and that oncology nurses were, in fact, special. The idea of working daily with patients such as her was frightening, but I decided I was up for the challenge. In just the first month, I learned so much it was mind-boggling. I was in awe of the other nurses and how they combined professionalism and compassion while balancing chemotherapy administration, blood transfusions, pain medications, educating and supporting patients and their caregivers, and all of the other numerous nursing responsibilities. I remember the first patient I cared for who lost his battle with cancer. This was the part of the job I had

february 2015 • Volume 6, number 1

worried about the most: Would I know what to say to grieving family members? How would I comfort them? I was blessed at that time with a healthy family, and I feared it would be difficult for me to relate to them or know what to say. When the time came, though, I instinctively knew what to do. I hugged these family members who I had seen every day, and I cried with them; I did not have to give it a second thought. At that moment, I knew that I had made the right decision and found my specialty, and I never looked back. I have been working as an oncology nurse for more than 25 years and cannot imagine working in any other specialty. I decided to pursue further education, first earning my certification as an oncology-certified nurse in 1992, then returning to college and graduating with a bachelor of science in nursing degree in 1996. At that time, most chemotherapy administration was moving from inpatient to outpatient settings, and I began work at a private oncology-hematology practice. It was during this time that my mother was diagnosed with breast cancer. We were so lucky—it was stage I, and she underwent a lumpectomy followed by radiation. I was fortunate to have the knowledge to help navigate her through the process, but I often wonder how this experience may have been different for my mother and family if I did not have a background in oncology nursing. Another 10 years seemed to fly by as I cared for my family and raised my son. I decided it was time to further my education once again. While in graduate school, I returned to the hospital setting (Inspira Health Network) to work as an oncology research nurse, and helped develop a survivorship pilot program for patients who were completing cancer treatment at the hospital. I met with patients as they finished therapy, completed a summary of care, reviewed possible late-term and long-term side effects, and gave healthy living recommendations for patients’ life after treatment. Through this work, I noticed that many patients were experiencing severe fatigue after treatment. This prompted me to do additional research on cancer-related fatigue and open an institutional review board–approved nursing research study: The Impact of Exercise on Cancer-Related Fatigue. Patients who completed cancer treatment and experienced fatigue were accrued to participate in a 60-day,

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

supervised, physician-referred exercise program at Inspira Fitness Connection, a certified medical fitness facility. Pretest and posttest exercise comparisons using the Brief Fatigue Inventory scale and a quality-of-life survey (QLQC30) revealed that study participants who completed the exercise program experienced a significant reduction in self-reported fatigue and a significant improvement in quality of life. After becoming a board-certified nurse practitioner in 2012, I moved into a new position as the nurse practitioner and nurse manager of the outpatient infusion center at Inspira Health Network. Many of the patients who receive treatment at the infusion center are uninsured or underinsured. They have multiple social and financial issues, and they need to be navigated and supported daily. It is a team effort that includes oncology nurses, oncology navigators, an oncology social worker, medical and radiation oncologists, and me. Together, we care for our patients, and it is the most rewarding job I have ever had. I truly feel like I make a difference and help provide access to quality care for patients who need it most. I attended the Academy of Oncology Nurse Navigators (AONN) conference in November 2013 to pursue my interest in cancer survivorship and meet other nurse navi gators. I soon became a member of the AONN Quality, Outcomes, and Performance Improvement Committee. This is a great platform to share best practices, share re-

sources, and mentor others to help provide the best quality care to all of our patients. I presented my study, The Impact of Exercise on Cancer Related Fatigue, as an abstract and poster at the 2014 Academy of Oncology Nurse & Patient Navigators (AONN+) conference, and I am very proud to have won the honor of first place in the category of Original Research on Survivorship Programs.

I have worked with many amazing nurses over the years who have become lifelong friends, and I have wonderful mentors who have continued to guide me throughout my career. I have worked with many amazing nurses over the years who have become lifelong friends, and I have wonderful mentors who have continued to guide me throughout my career. I continue to meet outstanding nurses through AONN+ conferences and committees who make a difference in the world every day. I am honored to be part of such an amazing organization. My first nurse manager was correct when she said that oncology nurses are special— and I am extremely proud to be one. g

ABOUT THE COVER New Life

Acrylic by a Person Diagnosed with Cancer Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition www.LillyOncologyOnCanvas.com It was March 2006 when my illness was diagnosed as breast cancer. I have received several surgeries, four months of chemotherapy and six weeks of radiation therapy. But my mind is fully charged with strength and energy. My life has changed so much since I’ve had cancer. Cancer has brought me hair loss, but I have gained the love of God. A new life with happiness led me to volunteer at one of the Korean organizations for disabled people, establish a department for disabled people in my church, and volunteer at the local cancer center. Now I dream of becoming a medical doctor. It is not easy to get into medical school for a 40-year-old cancer survivor, but I cannot give up. I am still in hormone therapy now, but I am enjoying every moment of my life.

february 2015 • Volume 6, number 1

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Navigation and support program development

Development of a Cancer Resource Center in a Rural Texas Border Community Heather Becker, PhD1; Willie Braudway2; Jill Maughan, MEd3; Amanda M. Warfield, BS4; Rev. Marvin D. Wood, BS4 1 The University of Texas at Austin School of Nursing, Austin, TX; 2Val Verde–Kinney Cancer Task Force, Del Rio, TX; 3 Texas Department of State Health Services, Austin, TX; 4Val Verde Regional Medical Center, Del Rio, TX Objectives: While many hospital-based survivorship programs have been developed in large cancer centers, it is important to understand how cancer support services can be delivered in small rural communities. The purpose of this article is to describe how contextual factors have influenced the development and evaluation of a cancer navigation and support program in a small Texas border community. Study Design and Methods: This descriptive explanation of the development of the HOPE Cancer Resource Room is based on observation and records review. Results and Conclusions: The HOPE Cancer Resource Room illustrates how a small border community can come together to build support services for patients with cancer and their families. Unlike many survivorship programs that operate in large cancer centers, the HOPE Cancer Resource Room focuses its efforts on connecting its survivors who are mainly of Hispanic origin and their families with available resources in the regional community, rather than linking them to hospital-based services. Its approach to the evaluation and delivery of services is informed by the community context in which it operates.

ancer survivors’ needs can vary depending upon the context in which they live. To maximize their quality of life, survivors in small communities and rural settings need services that fit their unique situations. The authors of A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies1 recommend the development of effective patient navigation systems and tools for diverse groups. The ultimate goal is to make quality cancer care available more equitably across the United States. Brownson and colleagues2 have pointed out that contextual factors (eg, education level, social capital, staff expertise, and sociocultural and political/economic factors) should inform evidence-based practice. Serrata and colleagues3 have also suggested a more “bottom-up” approach to understanding how local programs evolve and meet the needs of their communities. In this model, the use of documented evidence is tempered by environmental and organizational contexts as well as community and local professional expertise. The Knowledge Exchange– Decision Support Model also emphasizes the importance of local context when designing patient navigation programs.4 In particular, there is currently a need for more information about cancer care programs operating in rural settings and those serving a population that is largely of Hispanic origin. The purpose of this article, therefore, is to describe how contextual factors have influenced the development and

february 2015 • Volume 6, number 1

evaluation of a cancer patient support program in the Texas border community of Del Rio (Val Verde County) and adjacent Kinney County. Consistent with the commonly accepted definition of survivorship,1 we define cancer survivors as individuals and their families from the time of diagnosis through active treatment and beyond.

There is currently a need for more information about cancer care programs operating in rural settings and those serving a population that is largely of Hispanic origin. Community Context: Cancer Among Texans of Hispanic Origin in Val Verde and Kinney Counties

Although the rates of diagnosis and survival for most major cancers in Texans of Hispanic origin compare favorably with those of white Texans of non-Hispanic origin (notable exceptions being for cancers of the stomach, liver, and cervix), the cancer experience can nevertheless take a tremendous toll, particularly for those with low incomes.5 Texans of Hispanic origin are less likely to have health insurance or a personal provider, and are more likely to postpone seeking healthcare or routine medical checkups or cancer screenings.5

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Navigation and support program development

As of 2013 estimates, Val Verde County, located on the border with Mexico, has a population of 48,623.6 Of this population, 80% are of Hispanic origin, 33% of adults have less than a high school education, and approximately 22% live below the poverty line. The largest employers are the local schools and Laughlin Air Force Base.7 As of 2013, neighboring Kinney County has 3586 residents; of these, 57% are of Hispanic origin, 31% of adults have less than a high school education, and 26% live below the poverty line.8 Both of these counties are designated by the Texas Department of State Health Services as rural border counties.9 According to its 2013 Community Health Needs Assessment, the Val Verde Regional Medical Center (VVRMC) is the only hospital in Val Verde County.7 Located in the town of Del Rio, it is a 93-bed Joint Commission–accredited institution operated by the local hospital district. The direct-care physician ratio in 2010 for Val Verde County was 75.9 patients per physician; because of this physician shortage, many patients use the hospital’s emergency facilities for primary care concerns. According to the VVRMC assessment, only 20% of the patients served have HMO/ PPO coverage.7 The VVRMC would like to encourage more patients with cancer to receive services in the local community, rather than seeking care in San Antonio, approximately 180 miles away.

Community Oncology Resources

Del Rio has 1 oncologist and a registered nurse who has received extensive oncology training. Together, they provide some of the services commonly found in patient navigation systems, but they do not treat all patients with cancer in the area. The VVRMC has social workers and offers hospice care, respiratory therapy, physical therapy, and occupational therapy. Radiation services are available in Uvalde, approximately 70 miles away. There are no oncology services in neighboring Kinney County. Local general surgeons perform mastectomies and basic tumor removal, but more complex surgery is referred to the cancer center in San Antonio. Although patients who travel to that urban cancer center receive navigation services there, the navigators do not necessarily connect those patients with services in their local communities. Moreover, patients face the added expense of travel. Survivors who work and their family members have the added burden of taking time off from work to travel to receive cancer care. In 2005, the Texas Comprehensive Cancer Control Program (TCCCP) coordinator worked with local stakeholders to create the Val Verde–Kinney Cancer Task Force (Kinney County was added to the Task Force in 2007). Its stated mission is to “reduce the burden of cancer on the residents of Val Verde and Kinney counties…[by] creat[ing] and expand[ing] cooperative efforts that maximize

available cancer resources.”10 Its diverse membership includes nurses, cancer survivors, a librarian, an agriculture extension agent, a chaplain, and the regional representative of the American Cancer Society (ACS), and together they have undertaken multiple cancer control community projects in Val Verde and Kinney counties.

Although the Task Force has focused largely on educating the community, various members also argued for addressing the needs of patients with cancer and their families. Community Needs Assessment

In spring 2012, the Task Force gathered surveys from 650 residents to determine their ratings of importance for 8 cancer control strategies that had been suggested in previous stakeholder meetings. The surveys were administered in both English and Spanish and were distributed at various community locations. The top 4 strategies identified as important were (1) financial assistance with cancer expenses, (2) affordable and/or free cancer screenings, (3) more education on prevention and screenings, and (4) a central, staffed location for cancer information and referral services. The survey highlighted the barriers faced by many local residents who had been diagnosed with cancer, as well as their need for help in accessing necessary services. Once the data were compiled, the Task Force convened a community stakeholder meeting to discuss the results and their implications for community activities. The meeting also provided an opportunity to identify partners and resources that could be leveraged during the implementation of activities that were determined to be priorities from the community survey and the community stakeholder meeting.

Creation of the HOPE Cancer Resource Room

Although the Task Force has focused largely on educating the community about cancer prevention and early detection, various members also argued for addressing the needs of patients with cancer and their families. The regional representative from the ACS advocated for a specific location where cancer patients and families could receive information as well as services such as prosthesis/bra fittings. The representative offered to provide ACS materials and related resources. Other Task Force members recognized that such a resource room could become the vehicle for addressing the need for survivorship assistance identified in the recently completed community survey. The Val Verde Hospital District Board that oversees the VVRMC agreed to provide space, and others in the community gen-

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Navigation and support program development

erously donated remodeling services and materials. Initially, volunteers staffed the resource room. However, the coordinator of the TCCCP, which had helped create and provide technical support to the Task Force, informed the members about funds they could apply for that would enable them to hire a paid cancer navigator. In addition to direct funding, the TCCCP coordinator offered technical assistance and networking connections, such as the statewide Cancer Alliance of Texas, as well as assistance from the TCCCP evaluation team.

The CRR navigator largely focuses on assisting patients with obtaining the services they need outside of the medical center system. Financial aid has been one of the most requested areas of assistance. HOPE Cancer Resource Room: Mission and Activities

The HOPE Cancer Resource Room (CRR), a joint project of the VVRMC, the ACS, and the Val Verde–Kinney Cancer Task Force, opened in May 2012 with volunteer support. Its mission is to provide “free services to lessen [survivors’] burden as they journey through the cancer maze of emotion, diagnosis, treatments and finances.”11 Another major goal of the CRR is to identify barriers to cancer care. With funding from the Centers for Disease Control and Prevention through the TCCCP, a parttime CRR navigator was hired a few months later, and navigation services became available in January 2013. The CRR navigator’s activities reflect many of the navigator functions outlined by Willis and colleagues.12 These functions include ongoing identification of, coordination with, and referral to community resources; identifying resources to help survivors problem-solve and participate in informed decisionmaking; educating survivors and families about health promotion; and identifying and addressing barriers to care. Unlike survivorship programs that operate in major cancer centers, the CRR focuses more effort on connecting cancer survivors and their families with resources available in the wider community rather than linking them to hospital based services. Whereas the number of patients served in the CRR’s first year was small, patients’ needs are often complex, and the navigator estimates that it has taken 1 to 5 hours to locate needed resources and follow up with each patient. Not only does the navigator provide services within the CRR, but she also educates the community about the needs of cancer survivors and their families. Four to 6 volunteers assist the navigator in assessing the

february 2015 • Volume 6, number 1

needs of patients with cancer and their families and helping them locate community resources. These resources span the cancer continuum from prevention (such as information about smoking cessation programs) through diagnosis, treatment, and survivorship. Many online and print resources are available in Spanish and English. The volunteers, some of whom are bilingual, also assist the navigator with data collection and community outreach projects. In addition to the physical space for the CRR, the VVRMC contributes supervision for the navigator, background checks for volunteers, and assistance from bilingual staff for patients and families who are Spanish-speaking. As previously mentioned, the CRR navigator largely focuses on assisting patients with obtaining the services they need outside of the medical center system. Financial aid has been one of the most requested areas of assistance, so the navigator has compiled information about local resources for financial assistance that she can share with patients and their families. In addition, the navigator has created a flowchart to guide her volunteers in responding to financial aid requests. Those who go different routes in their cancer journey need different kinds of navigation assistance. Some residents who do not have a regular provider in Del Rio believe that if they travel to the emergency department in Bexar County (which must provide care regardless of ability to pay), they will be referred to free or low-cost oncology services at the comprehensive cancer center in the city of San Antonio (approximately 180 miles away). However, Bexar County is moving toward providing these financial aid services only to county residents. Consequently, the CRR navigator works with residents to obtain oncology, educational, and financial services within their local community, or arranges for appropriate referrals to the comprehensive cancer center in San Antonio. A unique aspect of this navigation service in an international border community involves linking Texans who have received initial medical services in Mexico (often for financial reasons) to services on the US side of the border. For example, individuals who have had their initial laboratory tests performed in Mexico often find that many US hospitals will not accept the results from these tests. These individuals, many of whom are low income, must then repeat their laboratory work in the United States. In such cases, the navigator can help these individuals find ways to pay for the necessary repeat laboratory work as well as get a referral to a local primary care provider so they can be directed to receive cancer care in the United States. She also educates families about the resources available within the United States so that they will not feel they have to go to Mexico for medical care. A key component of the navigator’s role has been to

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Navigation and support program development

develop collaborative networks in the community that will address the needs of cancer survivors. For the CRR, the term community has a broad geographic definition and includes adjacent counties, such as Uvalde, where radiation services are provided. Another major component of the navigator’s role is to make presentations about cancer-related local demographics, cancer awareness and prevention, the needs of cancer survivors, and the services and resources available in the CRR. These presentations are given within the hospital as well as to various community organizations. The navigator now receives calls requesting community presentations, whereas in the initial months of operation she had to request the opportunity to do so. When the navigator is contacted by individuals in the community who want to help cancer patients and their families, she works with these individuals to maximize such efforts, often in conjunction with the Task Force. The CRR’s services are publicized in many ways. The navigator distributes materials about the CRR at community events such as the ACS Relay for Life and various health fairs, and also promotes the CRR on various local radio programs. When volunteers assemble kits for patients who have had mastectomies, they also include information about the CRR. In addition, the CRR is featured on the hospital’s website, and information has been published in various newspaper articles.

Survivor Characteristics

Most of those visiting the CRR are patients who are newly diagnosed or still in active treatment, along with their family members. Many Spanish-speaking survivors bring English-speaking family members to help with translation, if needed. The CRR has some bilingual volunteers; when one of these volunteers is not available, the navigator can call on one of the many Spanish-speaking staff members in the hospital to help translate. Because many residents in the community have limited education and may not be fully literate in English or Spanish, written educational materials as well as data collection forms have to be kept simple and easy to read. For example, the navigator reported that forms provided by the ACS can be challenging; she has observed that family members and other interpreters have to reword and explain many of the items. To reduce the text burden for those accessing the CRR’s services, the navigator looks for online video resources or written materials that use lots of graphics, and also asks volunteers to offer to read forms to CRR visitors when necessary. The navigator has observed that many survivors and families seem reluctant to ask their provider questions about their diagnosis and treatment, preferring to simply accept the information given by the provider. Serrata and col-

leagues3 found that those of Hispanic origin are more likely to discuss health issues among family and friends than with healthcare providers. To address this, the navigator and the volunteers spend time coaching survivors about questions they might ask their providers and the role they might take in making decisions about their cancer care.

Evaluation Activities

During the first full year of its operation, the CRR had only 52 visitors; with time, this number has increased. Regardless, this initial number must be considered in the context of the number of patients diagnosed with cancer in Val Verde and Kinney counties. Between 2007 and 2011 (the latest year for which data are available), 951 cases of cancer were reported to the Texas Cancer Registry13; this is an average of 190 cases per year. Thus, the 52 visitors to the CRR in its first year represent approximately 27% of those likely to be diagnosed with cancer within a given year in these 2 counties.

Because many residents in the community have limited education and may not be fully literate in English or Spanish, written educational materials as well as data collection forms have to be kept simple and easy to read. In consultation with the TCCCP coordinator, the CRR staff has targeted the following annual objectives: (1) increase self-reported higher quality of life after cancer survivors receive CRR navigation referrals; (2) increase the percentage of cancer survivors who follow up on recommended CRR referrals; (3) develop a system to identify and quantify barriers to follow up on navigation referrals experienced by those using the CRR services; and (4) increase the percentage of healthcare providers and related organizations that collaborate with the CRR. In June 2013, the navigator created a Visitor Entry Database to track information about those using the CRR and to record the extent to which users had been able to follow up on recommended referrals as well as any barriers they encountered. Among the first 22 individuals tracked, 73% reported following up on recommended referrals, 9% had not followed up on the referrals, and 18% were lost to follow-up. The staff recognized that data collection forms for the Visitor Entry Database must be kept simple because of the low literacy levels of many of those using the CRR. To facilitate data collection, the navigator uses the visual guide

JONS-online.com journal of Oncology Navigation & Survivorship

Navigation and support program development

Figure Patient Navigation Guide # ×Please mark all numbers that apply to you. Testing for cancer

Caregiving

2 Recently diagnosed

Surgery

4 Consultation and decision

Chemotherapy

Late- and end- stage cancers

Recovery

Radiation

Printed with permission from Amanda M. Warfield, BS.

shown in the Cancer Navigation Key (Figure) to help visitors identify where they currently are in their cancer journey and to focus staff discussions with patients and families to pinpoint needed resources. Family members often help survivors complete written forms, but much follow-up data collection is conducted orally—often by phone. These conversations focus on how survivors and families have followed up on the navigator’s referrals; what barriers, if any, they have encountered; how useful they have found the services; and any suggestions for improvement. Through repeated efforts, the navigator has been able to reach the majority of those called for follow-up. After reviewing various existing quality-of-life measures, the navigator and her supervisor decided to use a simple 1-item questionnaire that asks respondents at follow-up to rate their agreement with the following statement: “My quality of life has improved after contact with the HOPE Cancer Resource Room and navigator.” The decision to use a single item to assess perceived contributions to quality of life reflects the need for data collection to be as simple as possible for the population served. The staff has used feedback from visitors to the CRR to fine-tune their services. For example, when initial information from visitors reflected numerous requests for financial information, the navigator began concentrating more effort on locating sources of financial assistance. The navigator and her supervisor recently calculated that, in 2013, CRR visitors saved $19,444 in healthcare costs, about half of which consisted of medication discounts that they learned about at the CRR.

Sustainability Through Community Collaborations

Because the CRR emerged from the collaborative activities of the Val Verde–Kinney Cancer Task Force, including members from the ACS and the VVRMC, it has always had a strong collaborative network to support it. By the end of 2013, the CRR was collaborating with 38 organizations, including community programs, social service agencies, home health agencies, diagnostic/treatment facilities, nursing homes, and clinics in a 4-county area within a 70-

february 2015 • Volume 6, number 1

mile radius. While sharing information is the most frequent collaborative activity, this network also shares resources and sends/receives referrals from the CRR. The navigator is an active member of the Task Force and regularly reports on CRR activities at Task Force meetings. Task Force members, in turn, have distributed brochures about the CRR within their networks. When the navigator voiced the need for financial aid for low income cancer patients and families traveling to the comprehensive cancer center in San Antonio, Task Force members (who are also heavily involved with the local United Way) encouraged her to apply to the United Way for money to provide gas cards for these patients. Task Force members who have relationships with local media have also arranged for multiple articles about the CRR to be published in the local newspaper.

The staff has used feedback from visitors to the CRR to fine-tune their services. Going forward, the CRR staff and the Task Force hope to expand patient support services by organizing cancer support groups. As the initial start-up funding provided by the TCCCP expires, the Hospital District Board has increased its support for the CRR. The medical center’s vice president for community relations has become a champion of the CRR, and she has advocated with the Hospital District Board for increased funding. She is working with the navigator and her supervisor to use the data they have been collecting to make a persuasive case to the board about the positive impact the CRR has made on the community. Through these efforts, the Hospital District Board has increased its support for the CRR, although the CRR staff and Task Force members continue to seek other support for CRR activities as well.

Conclusion

The development of the CRR reflects the influence of the components in the model proposed by Serrata and colleagues3 (ie, environmental and organizational contexts as well as community and local professional expertise) and demonstrates the importance of contextual factors when designing a program for cancer survivors. The needs of the largely low-income population of Hispanic origin living in a small community have focused much of the CRR navigator’s efforts on identifying financial resources to reduce the burden of cancer on these survivors and their families. The limited literacy level of many visitors to the CRR has led the staff to be creative in developing educational materials and collecting data.

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The Val Verde–Kinney Cancer Task Force, in partnership with the local medical center and the TCCCP, created the CRR and continues to nurture it. As such, the CRR story can inform those in other small communities, particularly those in border areas, about how they too might come together to develop resources to decrease the burden of cancer for their citizens. g Author Disclosure Statement: Rev. Marvin D. Wood, BS, reports being an employee of Val Verde Regional Medical Center, Del Rio, TX. All other authors have nothing to disclose. Corresponding Author: Heather Becker, PhD, The University of Texas at Austin School of Nursing, 1700 Red River St, Austin, TX 78701. E-mail: heatherbecker@mail.utexas.edu.

References

1. Centers for Disease Control and Prevention. A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2004. 2. Brownson RC, Baker EA, Leet TL, et al. Evidence-Based Public Health. Oxford, UK: Oxford University Press; 2011. 3. Serrata J, Rosales A, Macias L, et al. Documenting evidence based practice

in community based organizations: beyond promising practices. Paper presented at: Evaluation 2013; October 14-19, 2013; Washington, DC. 4. Howard AF, Smillie K, Chan V, et al. The Knowledge Exchange–Decision Support Model: application to cancer navigation programs. Support Care Cancer. 2014;22:367-374. 5. Goodwin JS; Comparative Effectiveness Research on Cancer in Texas (CERCIT) Investigators. A comprehensive report on cancer among Hispanics in Texas. Texas Public Health J. 2013;(suppl fall). 6. US Census Bureau. State & County QuickFacts: Val Verde County, Texas. http://quickfacts.census.gov/qfd/states/48/48465.html. Revised December 4, 2014. Accessed January 21, 2015. 7. Val Verde Regional Medical Center. Community Health Needs Assessment 2013. www.vvrmc.org/pdf/community-health-needs13.pdf. Accessed January 15, 2015. 8. US Census Bureau. State & County QuickFacts: Kinney County, Texas. http://quickfacts.census.gov/qfd/states/48/48271.html. Revised December 4, 2014. Accessed January 21, 2015. 9. Texas Department of State Health Services. Definitions of county designations: urban-rural designation for Texas counties, 2013. www.dshs.state.tx.us/ Layouts/ContentPage.aspx?PageID=35614&id=8179&terms=rural+border+ county. Updated June 10, 2014. Accessed January 21, 2015. 10. Val Verde–Kinney Cancer Task Force. www.chicdelrio.org/ctf/index. html. Accessed January 14, 2015. 11. Val Verde Regional Medical Center. Our services. www.vvrmc.org/servicescancer-resource.html. Accessed January 14, 2015. 12. Willis A, Reed E, Pratt-Chapman M, et al. Development of a framework for patient navigation: delineating roles across navigator types. J Oncol Navigation Survivorship. 2013;4:20-25. 13. Texas Cancer Registry, Cancer Epidemiology and Surveillance Branch, Texas Department of State Health Services. Age-adjusted invasive cancer incidence rates in Texas. www.cancer-rates.info/tx/. Accessed February 5, 2015.

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Quality Improvement Tools

Patient Experience Mapping: A Quality Improvement Tool for Patient Navigators Heather Kapp, LICSW, MPH; Mandi Pratt-Chapman, MA1 1 Director, The George Washington University Cancer Institute Background: To maximize the impact of breast cancer patient navigation at The George Washington University (GW) Cancer Institute, this project mapped the patient experience across the cancer continuum to identify how and where navigators could contribute to improving the quality of cancer care. Methods: The experience of patients with breast cancer was documented while they were undergoing cancer screening, diagnosis, and treatment. The patient navigation team mapped patients’ experiences using a process created and described by The Advisory Board Company. The Advisory Board Company developed the process by identifying best practices through interviews with its members. Results: The maps generated discussion about how system fragmentation and gaps in care affect patient care; they also generated discussion regarding potential ways that navigators can help patients on their journey through the complex cancer continuum and improve the overall patient experience. The navigation team worked together to identify feasible quality improvement projects to meet patient needs identified in the mapping process. Conclusions: Patient experience maps can be used to develop targeted quality improvement strategies for patient navigation programs. Process maps can identify system issues, variations across departments, and gaps in services, and foster communication between clinics regarding opportunities to improve services. For the GW Cancer Institute’s navigation team, mapping the patient’s process along the cancer care continuum helped prioritize quality improvement projects, illustrated how navigators can contribute to quality improvement, and ensured navigators were focused on core navigation duties.

he George Washington University (GW) Cancer Institute, in partnership with the GW Medical Faculty Associates and the GW Hospital, has established a comprehensive patient navigation service over the past 7 years to assist patients throughout the breast cancer continuum. In 2013, the institute’s navigation team—3 nonclinically licensed patient navigators, 2 nurse navigators, a cancer center social worker, and a navigation supervisor—mapped the treatment flow of patients with breast cancer. The objectives were to document gaps in the system as well as identify and implement quality improvement (QI) projects that would optimize patient care.

Methods

A navigation supervisor began this process by researching approaches to process mapping. Process mapping is described by The Advisory Board Company,1 the Midland Region Cancer Control Project,2 and Shockney.3 The Midland Region Cancer Control Project utilizes a process mapping methodology developed by the Cancer Services Collaborative Improvement Partnership, which is a National Health Service program that makes improvements to cancer care. Its methodology was comprehensive, but

february 2015 • Volume 6, number 1

the process was more rigorous than resources allowed. For example, the Midland District Health Boards included epidemiologic data, patient feedback, and input from 130 staff members.2 Shockney’s patient flow resource was discovered after the mapping project was finalized. The Advisory Board Company’s method was chosen for its ease of implementation by a small team that was focused on identifying concrete QIs within a 6-month period. All approaches were valued for being iterative and inclusive. Key steps in the patient experience mapping project included the following: (1) determining the approach, (2) forming a team, (3) establishing realistic goals, (4) drafting patient experience maps, and (5) refining the maps through broader stakeholder engagement. Determining the Approach The Advisory Board Company’s process suggested diagramming each step in the patient experience. The GW Cancer Institute found that this allowed its navigators to discuss operational issues and opportunities for improvement in a nonthreatening manner. The process involved an examination of the separate steps in the cancer care continuum from referral for an abnormal finding to com-

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Quality Improvement Tools

pletion of treatment and discharge from cancer care. Information about the patient’s care was documented by focusing on what happened to the patient, including communication, administrative, and diagnostic processes throughout his or her cancer episode. Forming a Team The navigation supervisor took the lead to ensure the mapping project was initiated, QI projects were implemented, and QI progress was measured. She engaged the previously mentioned core team of 3 nonclinically licensed patient navigators (patient navigators), 2 nurse navigators (nurse navigators), and a social worker. Together, this group was referred to as “navigators” or collectively as “the navigation team.” This navigation team documented typical patient experiences and identified performance improvement goals by describing the ideal patient experience. These findings were shared with breast care nurses and physicians to verify perceptions. Establishing Realistic Goals The main goal of the project was to maximize the impact of the navigation team by identifying patient needs, care coordination gaps, and system fragmentation that the navigators could feasibly address. The navigation supervisor selected process improvements over which the navigators had control to help demonstrate their impact. A key to success was to ensure goals were specific and achievable. A main challenge throughout the course of this project was remaining focused, as the maps detailed a highly complex series of appointments, staff interactions, departments, and services needed for breast cancer care, including referrals to outside organizations. The process maps provided an opportunity to show that the navigator’s role is critical in coordinating cancer care and highlighted how navigators can lessen fragmentation for patients. A pri mary goal was to coordinate a seamless cancer experience for each cancer patient. Drafting the Patient Experience Maps First, the navigators diagrammed the patient flow for each clinical area, including breast imaging, breast surgery, hematology/oncology, radiation oncology, and the survivorship clinic. Multiple drafts of the diagrams were discussed as a team, and opportunities were identified to best utilize each navigator and avoid duplicating work. Many different drafts were shared with staff members until they agreed that the charts accurately represented the actual process for a patient with breast cancer. The team examined when and how referrals are made to the navigators, the ideal time for referral to the Thriving After Cancer survivorship clinic, and the best process to assess barriers to

care and screen for distress. Themes emerged such as capacity limits of clinics and staff, lack of awareness of available psychosocial support for patients and families, risk of breakdown in communication, and an overall lack of care coordination. The identification of these themes served as a starting point for discussing solutions. The navigation team refined the maps through a consensus-based process until the flow for a patient with breast cancer was completely diagrammed. QI initiatives were prioritized based on feasibility of the navigation team to address the identified gaps. Final drafts of the flowcharts were standardized and abbreviations eliminated to ensure comprehension across departments. Refining the Maps Through Broader Stakeholder Engagement A broader group of stakeholders were engaged to validate project findings and ensure support for resulting QI initiatives. These stakeholders included nurses, physicians, and radiology staff. The GW Cancer Institute focused on the Breast Imaging & Intervention Center initially, as its patient navigator was being asked by multiple team members to assist with administrative tasks, distracting her from focused navigation for patients. The maps were a useful discussion point with the Breast Imaging & Intervention Center team because they highlighted patients’ needs and how the patient navigator and nurse navigator could meet these needs. The GW Cancer Institute continues to use the maps to strengthen relationships with clinical staff. The maps also promote the services that navigators can provide to support care coordination and raise awareness for critical psychosocial care, including survivorship and rehabilitation services.

Results

The patient experience maps demonstrate the complexity of treatment for a patient and highlighted the need for navigation support. Cancer care is delivered in a variety of settings and involves many services from imaging through treatment and rehabilitation. Cancer treatment often includes surgery, chemotherapy, and radiation. The flowchart, as shown in the Figure, provides a detailed depiction of the experience a patient with breast cancer has in just 1 clinical area. Similar maps were created for additional clinical areas, including hematology/oncology, radiation oncology, breast surgery, and the survivorship clinic. As shown in the Figure, 1 patient navigator and 1 nurse navigator work together in the Breast Imaging & Intervention Center. During our process, several key issues and themes emerged, including the following: • There is a strong risk of breakdown in communication and coordination across the care continuum

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Quality Improvement Tools

Figure Breast Imaging & Intervention Center Map

Screening/ Diagnostic

Appointments made by patient or with help of patient navigator.

Patient or patient navigator obtains referral or physician order. Patient navigator checks referral for accuracy. Patient comes to clinic.

Patient navigator identifies resources, removes barriers to care (continuous).

Normal results mailed to patient, faxed to referring physician.

Abnormal results given in person. Patient navigator assists with scheduling next appointment. Nurse navigator provides clinical education.

Uninsured insured

Abnormal Screening

Mammovan helps uninsured patients apply for Project Wish coverage. If not eligible, internal fund covers biopsies. Patient navigator explains costs to selfpay patients.

Cancer Diagnosed

Nurse navigator meets with patient to assess patient comprehension, explain next steps, and assist with scheduling follow-up. Patient navigator assists Spanish-speaking patients.

Surgery Consult

Patient navigator assists patients who need preadmission testing before surgery.

BI-RADS 0: Physician reviews results with patient within 1 week. Follow-up is scheduled. Patient navigator calls those lost to followup.* BI-RADS 3: Patient navigator calls patients overdue for 6-month appointment.*

Patient navigator makes appointment for those needing biopsy.* Patient has biopsy. Physician reviews results within 1 week. Nurse navigator educates patients. BI-RADS 4 and 5: Patient navigator assists with scheduling and referrals.*

Physician reviews Breast-Specific Gamma Imaging results with patient within 1 week.

If MRI is needed, patients may need to obtain insurance approval number. Patient navigator schedules appointment. Results mailed to patient, faxed to primary care provider.

Nurse navigator calls newly diagnosed patients (BI-RADS 5) within 2 days and completes phone introduction.*

Patient navigator assists with scheduling additional imaging or biopsies.*

Patient navigator and nurse navigator remain available for patients who need additional assistance.

BI-RADS indicates Breast Imaging Reporting and Data System; MRI, magnetic resonance imaging; QI, quality improvement. *Indicates QI priority. Printed with permission from Mandi Pratt-Chapman, MA.

• Patients must take several steps to implement their transitions through screening, diagnosis, multiple modes of treatment, and posttreatment survivorship. Adding to this complexity, these steps are usually over a long period of time with several “handoffs” between services • Handoffs during patient transition points were highlighted as critical points where navigators could support the medical team to ensure patient follow-up. The project resulted in QI initiatives for each member of the navigation team. See the Table for a breakdown of gaps

february 2015 • Volume 6, number 1

in the care continuum and resulting improvement initiatives for each clinical area mapped. The QIs identified in the Table improved handoffs between navigators across clinical departments and ensured more timely access to follow-up care. Another significant result of the project was documentation, approval, and implementation of a distress screening policy to ensure earlier psychosocial support services. This process has been identified as a best practice.4 To date, the following progress has been made within the Breast Imaging & Intervention Center:

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Quality Improvement Tools

Table Identified Gaps and Quality Improvement Opportunities in Selected Clinical Areas Clinical area Gap identified QI opportunity Breast Imaging & Intervention Center and Breast Care Center

Delays in connecting patient to navigation services

Systematic introduction to navigation services: patient navigator calls newly diagnosed patients to assess barriers to care in the Breast Imaging and Intervention Center, initiates handoff to patient navigators in the Breast Care Center (surgery) and Radiation Oncology to ensure seamless support

Breast Imaging & Intervention Center

Loss to follow-up

Patient navigator calls patients to inquire about barriers to completion of the diagnostic process and the 6-month followup appointment

Breast Imaging & Intervention Center

Time lag and lack of education for patients after biopsy

Nurse navigator provides educational consult and navigation for patients with BI-RADS 4 and 5

Breast Imaging & Intervention Center

Inaccurate referrals and resulting Patient navigator works to address incorrect referrals on the time delays spot so patients do not have to reschedule their appointment

Breast Care Center (surgery)

Delayed authorizations for procedures

Patient navigators ensure authorizations are obtained for presurgical procedures

Radiation Oncology

Delays in referral to support services

Nurse screens for distress using NCCN Distress Thermometer, triages nonclinical barriers to the navigation team and clinical concerns to the clinical team

Breast Care Center & Radiation Oncology

Limited patient referrals to survivorship services

Navigators systematically refer patients to survivorship navigator (eg, mail letters to patients after surgery to inform them of the clinic); update survivorship brochure

BI-RADS indicates Breast Imaging Reporting and Data System; NCCN, National Comprehensive Cancer Network; QI, quality improvement.

• Improved tracking of women called for follow-up after a screening mammogram, reducing loss to follow-up • Development of a telephone-based navigation assessment tool • Development and delivery of an educational presentation that identifies referral codes for screening mammogram, diagnostic mammogram, core needle biopsy, fine needle aspiration, and stereotactic biopsy, along with an explanation of the different indications for these procedures to reduce common referral mistakes from federally qualified health centers • Strengthening of relationships in the community to fasttrack services for at-risk women • Reduced wait times for patients who require additional testing.

Conclusions

Mapping the patient experience across clinical departments can help to identify gaps in care and prioritize QI strategies. While this process improvement project was resource intensive for staff, it laid the groundwork for continuous QI. Sustained efforts are critical to ensure improvements are made in cancer care. The process proved to be effective in engaging staff across clinical departments while minimizing resistance. Opportunities for QI were often complicated and, therefore, not easy to address. Further, capturing data to measure QIs can be challenging in a busy

clinic, but evaluation is critical to show impact. The GW Cancer Institute mapping project focused on how patient navigators and nurse navigators could meaningfully contribute to QIs to better the patient experience. The project resulted in adjustments to navigator duties to ensure navigators were focused on addressing the gaps that most impacted timely, patient-centered care. A systematic distress screening policy was documented and implemented in partnership with the hematology/oncology social worker. Finally, the survivorship clinic received increased referrals as a result of this process. The GW Cancer Institute will periodically revisit the mapping process to initiate new QI projects. Strengths of this approach are flexibility to respond to the unique needs of patients in a particular clinic or health system and the capacity to adapt as patient and system needs change. g Acknowledgments: Navigators Monica Dreyer, MA; Eva Ruiz, BS; Diana Garcia, BS; Elizabeth Hatcher, RN, BSN; and Leshia Hansen, RN, BSN, MPH, contributed to the mapping project. Source of Funding: This project was directly supported by the Avon Foundation for Women. Support for the GW Cancer Institute’s navigation program is provided by the Avon Foundation for Women, the Susan G. Komen

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Foundation, the American Cancer Society, and operational funds. Author Disclosure Statement: Ms Kapp does not have any disclosures to report. Ms Pratt-Chapman reports being a grant recipient of Genentech and Amgen and an advisor to Pfizer; she indicates that the companies did not fund any aspect of the manuscript or activities described within it. Corresponding Author: Mandi Pratt-Chapman, MA, Director, The George Washington University Cancer Insti-

tute, 2030 M Street #4070, Washington, DC 20036. E-mail: mandi@gwu.edu.

References

1. The Advisory Board Company. Oncology Roundtable Interviews and Analysis. Patient experience mapping tool. 2011. 2. Hewitt J, Scanlan L; Midland District Health Boards. Midland Region Cancer Control Project: Patient Mapping Project. www.midlandcancernetwork.org. nz/file/fileid/12557. Accessed February 6, 2015. 3. Shockney LD. Becoming a Breast Cancer Nurse Navigator. Sudbury, MA: Jones and Bartlett Publishers; 2011. 4. Pratt-Chapman M, Kapp H, Willis A, Bires J. Catalyzing patient-centered care: start where you are and share what you know. Oncology Issues. January/ February 2014:30-39.

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INDICATION: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics. Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatmentrelated cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion

with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted. Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known. Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms. Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remain consistent in the studies of multiple myeloma with no evidence of cumulative thrombocytopenia or neutropenia in the treatment regimens studied. Monitor complete blood counts (CBC) frequently during treatment with VELCADE. Measure platelet counts prior to each dose of VELCADE. Adjust dose/ schedule for thrombocytopenia. Gastrointestinal and intracerebral hemorrhage has occurred during thrombocytopenia in association with VELCADE. Support with transfusions and supportive care, according to published guidelines. In the single-agent, relapsed multiple myeloma study of VELCADE versus dexamethasone, the mean platelet count nadir measured was approximately 40% of baseline. The incidence of bleeding (≥Grade 3) was 2% in the VELCADE arm and was <1% in the dexamethasone arm. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions. Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients. Embryo-fetal Risk: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses. ADVERSE REACTIONS: In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions (≥10%) in this study (VELCADE+melphalan and prednisone vs melphalan and prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).

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Brief Summary (cont’d) are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information. Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients. Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication. OVERDOSAGE: There is no known specific antidote for VELCADE overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which were associated with the acute onset of symptomatic hypotension and thrombocytopenia. In the event of an overdosage, the patient’s vital signs should be monitored and appropriate supportive care given. PATIENT COUNSELING INFORMATION Advise patients to contact their physicians if they experience the following symptoms: Dehydration/Hypotension, such as dizziness, light-headedness or fainting spells, or muscle cramps. Cardiac: swelling of feet, ankles, or legs, or other heart-related problems. Respiratory: shortness of breath, cough, or other lung problems. Hepatic: jaundice or right upper abdominal pain. Dermal: rash, severe injection-site reactions, or skin pain. Discuss the option for antiviral prophylaxis for herpes virus infection. Peripheral Neuropathy and Nervous System, such as new or worsening tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. Advise patients to contact their physicians if they experience symptoms possibly indicative of PRES or PML such as convulsion, persistent headache, reduced eyesight, blurred vision, confusion, lethargy, altered ability to think, or difficulty walking. Other: increase in blood pressure, bleeding, fever, constipation, or decreased appetite. In addition, counsel patients on the following: Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with VELCADE. Instruct them to report pregnancy to their physicians immediately. Advise patients that they should not receive VELCADE while pregnant or breast-feeding. If a patient wishes to restart breast-feeding after treatment, she should be advised to discuss the appropriate timing with her physician. Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking. Diabetic Patients: Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level. Ability to Drive or Operate Machinery or Impairment of Mental Ability: Advise patients not to drive or operate machinery if they experience fatigue, dizziness, syncope, or orthostatic/postural hypotension. Please see full Prescribing Information for VELCADE at VELCADE-hcp.com.

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. Other trademarks are the property of their respective owners. Copyright © 2014, Millennium Pharmaceuticals, Inc. USO/BOR/15/0040 All rights reserved. Printed in the USA

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In the phase 3 study of VELCADE® (bortezomib) administered intravenously vs dexamethasone in relapsed multiple myeloma, the most commonly reported adverse reactions (>20%) were nausea (52% vs 9%), diarrhea (52% vs 11%), fatigue (39% vs 25%), peripheral neuropathies (35% vs 4%), thrombocytopenia (33% vs 3%), constipation (30% vs 8%), vomiting (29% vs 3%), and anorexia (21% vs 2%). The most commonly reported serious adverse reactions were diarrhea (3%), dehydration, herpes zoster, pyrexia, nausea, vomiting, dyspnea, and thrombocytopenia (2% each) in the VELCADE treatment group and pneumonia (4%), hyperglycemia (3%), pyrexia, and psychotic disorder (2% each) in the dexamethasone treatment group. In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions (≥10%) in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group. In a single-arm, open-label study of retreatment with intravenous VELCADE in relapsed multiple myeloma, the most common adverse drug reaction was thrombocytopenia, which occurred in 52% of patients (grade ≥3: 24%). Peripheral neuropathy was experienced by 28% of patients (grade ≥3: 6%). The incidence of serious adverse reactions was 12.3%; the most commonly reported serious adverse reactions were thrombocytopenia (3.8%), diarrhea (2.3%), and herpes zoster and pneumonia (1.5% each). DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalanprednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant. USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of VELCADE in children has not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment: The pharmacokinetics of VELCADE

Oncology Nurse Excellence Award

Jessica Engel Named ONE Award Winner at AONN+ Conference

t the Academy of Oncology Nurse & Patient Navigators (AONN+) Fifth Annual Conference, held in Orlando, FL, in September, one nurse was recognized by her peers for her commitment to the profession. Jessica Engel, DNP, FNP-BC, AOCNP, nurse practitioner and research assistant at the Marshfield Clinic in Stevens Jessica Engel, DNP, FNP-BC, Point, WI, was the recipient of the 2014 AOCNP Oncology Nurse Excellence (ONE) Award. Nominated by Adedayo Onitilo, MD, PhD, MSCR, FACP, a physician and colleague at the clinic, Dr Engel is also an instructor in the doctorate of nursing practice (DNP) program at the University of Wisconsin in Oshkosh and Eau Claire. In addition, she has been actively involved in research for the past 8 years, serving as primary investigator, coinvestigator, and project manager, and producing more than 35 peer-reviewed publications. In making the nomination, Dr Onitilo cited Dr Engel’s role as a clinician, educator, and researcher. “Dr Engel consistently receives excellent patient satisfaction reviews and goes to great lengths to ensure optimal care for her patients,” Dr Onitilo wrote. “She demonstrates her commitment to education as a professor, and her accomplishments in the field of oncology research set her apart.” Following is an interview with Dr Engel.

Q: How long have you been a nurse? Jessica Engel (JE): I have been a nurse in one form or another for a number of years. I graduated nursing school with my bachelor’s degree, and began working as an oncology nurse while I completed a master’s program to become a nurse practitioner. I then continued as a nurse practitioner in a hematology/oncology clinic and hospital setting. I moved to the Marshfield Clinic in Central Wisconsin, and I have worked in Stevens Point at the cancer center for the past 9 years. I went back to school and earned my DNP in 2013. I came to nursing actually just at an appropriate time for me. Having always had an interest in science, I had earned a bachelor’s degree in biology. As I was beginning medical school, I learned about the job of nurse practitioner, and that seemed to be a much better fit for me, for what I wanted to accomplish for myself and for how I wanted to be able to take care of patients.

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Q: What inspired you to become a nurse practitioner, and what path brought you to the position you are in now? JE: My intention was always to do something in the science field. I considered engineering or something in math and science. But about a year and a half into college, when I was 19, I was diagnosed with Hodgkin lymphoma. That diagnosis helped turn me toward the medical field, something I had not considered before. I really respected the doctors, nurses, and other people who cared for me, especially the knowledge they had about the process of diagnosis, treatment options, and the science behind all of that information. Early on in my experience with Hodgkin lymphoma, though, I began to understand that the importance of considering the emotional and interpersonal impact of a new cancer diagnosis can be just as important as understanding the science of oncology.

I find it most rewarding to have the opportunity to be helpful in real and useful ways and to provide support to the patients and people who I work with. Patients are trying to understand their diagnosis and how it has, and will, impact the other parts of their life, and at times they might be unsure how to relate to or explain how they feel to the people who are trying to care for them. As I considered that, and my newfound interest in the medical field, it seemed the right thing for me to do was redirect my focus toward a career where I would be able to use my experiences as a patient as well as gain the knowledge as a healthcare provider to be able to help others as I was.

Q: What inspires you and motivates you each day? JE: I really try to have a sense of purpose with all the work that I do. Most days that sense of purpose involves helping and supporting others, such as providing guidance for our patients to be the best that they can be or helping my coworkers do the best job they can so that they in turn can then provide better patient care and better services to our community. Another strong motivator for me is the ability to con-

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tribute to patient care, staff development, physician practice, research projects, and nursing student education. In my teaching role, I like being able to teach nursing students to do a good job, and with the research work that I do, especially with publications, I like to be able to put knowledge and information out there for others to use. Those things are really important to meâ&#x20AC;&#x201D;to be able to come to work each day and know my time is worthwhile in those ways.

Q: What role do you think nurses have in clinical research and education? What impact does this have on patient care? JE: As nurses often do not have the opportunity to conduct research independently, I think it is very important to understand that there is great value in becoming part of a research team; it allows nurses to see opportunities and make contributions they might not otherwise have been able to make. Nurses can contribute to a research team in a number of ways, such as the development of concepts and study ideas, or to assist with writing protocols and grant applications, participate with the implementation and conduct of studies, as well as be part of analysis and manuscript writing. By being part of a research team, a nurse is able to use the talents they have as well as learn more about the process of conducting studies overall. Nurses can participate in research in a number of other ways, such as a peer reviewer or by reviewing grant applications for larger funding groups. With respect to nursesâ&#x20AC;&#x2122; role in education, there are many opportunities that span the spectrum from nurses as learners, to nurses as teachers. Nurses can be classroom or clinical instructors. They can be preceptors. Nurses can develop continuing medical education programs, or can write articles for journals that would address areas helpful to educate the nurse readers. In this economic climate, where finances are tight and people are not always able to travel, online programs provide excellent opportunities for nurses seeking additional education. It is important for nurses to take the initiative and try to find educational opportunities that are cost-effective and time-effective. I would encourage nurses to always look for ways to build their knowledge base in their area of specialty, whether that is by obtaining relevant certification or advancing their formal education. Q: What do you find most rewarding about the work that you do? JE: I find it most rewarding to have the opportunity to be helpful in real and useful ways and to provide support to the patients and people who I work with. It is very rewarding to know that patients might learn new information; maybe I talked with them or saw them or did some kind of

Lillie D. Shockney, RN, BS, MAS (left), and Sharon Gentry, RN, MSN, AOCN, CBCN (right), present the ONE Award to Jessica Engel, DNP, FNP-BC, AOCNP, at the Fifth Annual AONN+ Conference in Orlando, FL.

workup, and they have an understanding about their question or condition that they did not have before. In oncology you do not always deliver good news, but you can always try to make things understandable. You can always try to find something that can make the situation a little bit better, or a little more acceptable. Working with colleagues in the clinic or in my research group, knowing that I support their interests, care, and work so that they are able to do a better job is very rewarding to me. I have learned that each bit of knowledge gained

Always help each other and find ways to share your knowledge and resources. Be kind to your patients and to those who you work with. Be persistent, be creative, and be open to opportunities, because you never know what is going to come up next. or each accomplishment builds on that before it, and each can be a stepping stone toward future opportunities. However, maybe the most important to me, is that I know I am fortunate that I find happiness in what I do. It is not just my job; being an oncology nurse practitioner and researcher is how I choose to live my life. I hope that some of my happiness, interest, and enthusiasm for my work are things that I am always able to share with others.

Q: What do you feel are the benefits of being a member of AONN+?

JE: What I have and will benefit from the most are the

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Oncology Nurse Excellence Award

resources, support, and sense of community. I went to the annual meeting this past year and felt like I really belonged as part of that group. AONN+ has a strong focus on education and quality of care, as well as communicating the importance of certification and job definition. Developing and maintaining standards is very important for the field as a whole. Those are benefits that the organization provides not just to its members, but also to hiring organizations or the medical care community so that there are standards for nursing and navigation jobs. That makes it easier for more roles to be developed and for more people to be hired into those positions.

My best advice is to find someone who can be a mentor for professional development. Also, never stop learning how to be better as a nurse, as a navigator, as a nurse practitioner, or how to be your best self. Q: How did you feel when you learned that you were nominated for the ONE Award? How did you feel when you won? JE: Everybody has good days and not-so-great days, and the day I found out about the nomination, it had started off as one of those days that was a little too busy and a little too sad, and I could tell that it was going to be a harder day to get through. When the e-mail notification came about the nomination, though, all of that just vanished. I read the e-mail a couple of times and realized what it meant. I had not been aware that I was being nominated, so it was a complete surprise. It felt very good that even as challenging as it gets, people really do appreciate your work. It was a nice reminder that day, and on many days since, that what I do is important and helpful to others. Reading the descriptions of the other nominees also made me think that this is a group of wonderful nurses, and I was so happy to be considered part of that group. At the meeting, when the number of members was described, the impact of how many people who were part of the

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organization, and, therefore, how many received the e-mail with our pictures and brief biographies really hit me as I was sitting in the audience. I actually felt a little shy at that moment as well as excited that I and my work had been considered by so many. When my name was announced, I said a silent thank you, meant especially to those who sent in the nomination, to all the other nurses who were nominated for their work, and to those who had voted. I was very proud and excited as I walked to the stage to accept the award.

Q: What advice can you give to other nurses, nurse navigators, or nurse practitioners, especially those who are just starting out? JE: My best advice is to find someone who can be a mentor for professional development. Also, never stop learning how to be better as a nurse, as a navigator, as a nurse practitioner, or how to be your best self. Other advice that I would give, as it has served me well, is to always help each other and find ways to share your knowledge and resources. Be kind to your patients and to those who you work with. Be persistent, be creative, and be open to opportunities, because you never know what is going to come up next. Be professional and responsible, and try to become as knowledgeable as you can about your content material and about your field. Pursue education and pursue any certification that you think might be helpful. Q: Is there anything else you would like to mention that we have not discussed? JE: I am so very appreciative of being selected for this award, and very much thank AONN+ and the members of the organization for their overall recognition and promotion of quality nursing and improving patient care. I offer my gratitude also to the people who nominated me and to all those who I am fortunate to work with who support me in all the different ways that allow me to keep doing what I do. I also want to thank the award sponsors* for making this possible and for helping to bring such a wonderful group of people together at the annual meeting. g *ONE Award sponsors include Bristol-Myers Squibb, Celgene, Eisai, Genentech: A Member of the Roche Group, Helsinn, Lilly, Pfizer Oncology, Takeda Oncology, and Teva Oncology.

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APRIL 18-22, 2015 PENNSYLVANIA CONVENTION CENTER PHILADELPHIA, PA

Join us in Philadelphia

for the most comprehensive cancer research meeting in the world... the AACR Annual Meeting 2015! Connect with the international cancer research community to foster new collaborations, learn about cutting-edge advances, and obtain feedback on your research. This must-attend meeting covers every aspect of cancer â&#x20AC;&#x201C; from epidemiology, molecular biology, and clinical studies to prevention, survivorship, and patient advocacy.

We look forward to welcoming you to our hometown of Philadelphia, PA!

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perspectives on cancer care

Clinician and Survivor Shares Perspectives on Cancer Care An Interview with Lillie D. Shockney, RN, BS, MAS

he Journal of Oncology Navigation & Survivorship (JONS) recently conducted the following interview with Lillie D. Shockney, RN, BS, MAS, Administrative Director, The Johns Hopkins Breast Center; Director, Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins; and Associate Professor, Johns Hopkins University School of Medicine and Lillie D. Shockney, RN, BS, MAS School of Nursing, Baltimore, MD. Ms Shockney is also a cancer survivor and the editorin-chief of JONS.

Q: What do you think are the most pressing issues facing patients in your community who are seeking care? Lillie Shockney (LS): In our particular community in East Baltimore, the majority of patients who are coming to us are part of an underserved population. They experience a fear of coming to the institution for screening. They have heard of other people coming to the emergency room with pain and subsequently dying. They assume that something happened to them while they were at the hospital and don’t really understand that a delay in diagnosis or having neglected cancer is something that not only will result in death but is something that can be prevented. They also may be very worried about the cost of care. If they don’t have insurance or are underinsured, that also can be a barrier that keeps them from coming to see us. They also have other things that take priority. I had a patient last year who was diagnosed with metastatic breast cancer. We treated her a few years before for locally advanced disease, and she said to me, “I can’t afford to die. I have to be here to raise my son. As you know, I had a delayed diagnosis before because I was spending time trying to keep my husband out of jail. He is now in prison. I then tried to keep both my boys alive. My one boy died here on the streets of Baltimore as a gang member. He got into a gang war and died. I have one son left. I want to get him on the right path, and that’s going to take some time.” As you can see, if they are dealing with life and death in very different ways, cancer is not on their radar screen.

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Q: How do the nurses and physicians address the issues found within this patient population? LS: They are faced with some tough issues. This patient may not consider her cancer diagnosis a priority, because instead she’s focused on how to get food on the table and, how to keep her son, who is part of a gang, alive. We need to factor those issues in. Because they aren’t going to consider this a priority, we need to make it a priority, and help them understand that by overcoming their cancer, by getting it appropriately treated, they may be in a better position to help their family.

One of the best ways to facilitate access to care is to assess the resources that are available within our own community. We often assume that all resources need to come from our cancer center, when the majority of them are out there in the form of patient advocacy organizations. We need to give them resources, as well. In some cases, it may be that we need to get a female patient into House of Ruth (intimate partner violence center) so that she is not going back home into a domestic violence setting. It also means that we need to make sure that patients do have food on the table, that they have access to psychosocial support, and that they can afford their prescriptions, which may mean utilizing resources to cover copayments and related expenses.

Q: What tips would you share with nurse or patient navigators to facilitate access to care for their patients? LS: One of the best ways to facilitate access to care is to assess the resources that are available within our own community. We often assume that all resources need to come from our cancer center, when the majority of them are out there in the form of patient advocacy organizations. Whether it is transportation assistance or coverage for copays, resources do exist in the majority of community settings or state‑based settings. Navigators simply need to ask.

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perspectives on cancer care

Q: Some institutions may feel intimidated about starting a navigation program. What would you recommend to start the process? LS: Some institutions feel vulnerable when they are in the process of determining how to develop a navigation program. There is not one particular program or process that fits every single institution; it should be tailored toward the patient population being served as well as the institution’s organizational structure. One of the best ways in which an institution can initiate a program without feeling too intimidated is to visit other institutions that have already developed such programs and published regarding their success. That’s a really good starting point. Institutions and centers should assess from an operations management process how their patients currently flow through their program. Do not assume anything; follow alongside a patient and see what really happens from the point of diagnosis, rather than what they have been told happens. That will provide a great deal of insight as to where the inefficiencies are, where things need to be reworked, where there are barriers to care that must be identified and resolved for their patient population, and where their nurse navigators and patient navigators can be of the best use. Cancer centers that are implementing a navigation program can also visit other centers for a site visit to see how they were successful in implementing such a program. Q: Are there any barriers to care within Johns Hopkins’ patient community? LS: There are many barriers faced by patients who receive care at Johns Hopkins. One is transportation. We may have a patient who says, “We have a car, but my husband uses it to go to work. I use the subway.” The subway may not be near their care center; we can provide resources to ensure they have transportation to get there. Asking the right questions and how the questions are asked regarding the barriers very much influences whether a patient will honestly tell us what the barriers are. If I say to a patient, “You are not going to have any trouble covering your prescriptions, are you?,” that is kind of a mother– daughter type of conversation, which is inappropriate. But if instead I say, “A lot of medications are expensive, and you weren’t planning to build into your budget a $50 bill each month to take this medication that’s really impor tant for preventing recurrence of your adjuvant cancer. Is this something I can help you with?” Now, that patient is going to feel far more comfortable in saying, “Yes, I don’t have those extra dollars, whatsoever. If you could help me with that, I would greatly appreciate it.” We also have issues such as ethnicity and racial barriers. We have large African American and Korean populations

in downtown Baltimore. Culturally and from an ethnicity perspective, there may be language barriers when we are trying to explain their treatments to them. They also have myths associated with cancer and its diagnosis. Some actually refer to their diagnosis as “cancer fate,” meaning that if you get it, then you are destined to die, so why bother being treated?

Q: You offer the unique perspective of being a patient with cancer, a cancer survivor, and a healthcare provider. Based on this experience, what insights can you give to fellow nurses and care managers to improve patient care? LS: I have had either the good fortune or misfortune to experience cancer from several different venues. One is as a patient. I’m a 23‑year breast cancer survivor, also a 21‑year breast cancer survivor, and an 8‑year uterine cancer survivor. I flipped to the other side of the side rail. I’ve also been in the field of oncology nursing and nurse navigation for a very long time, and serve formally as a clinician at Johns Hopkins.

Do not assume anything; follow alongside a patient and see what really happens from the point of diagnosis, rather than what they have been told happens. That will provide a great deal of insight as to where the inefficiencies are. One of the most important things I can share with nurses, nurse navigators, and care managers is that the patient is more than his or her pathology. We focus so much on the stage of the disease, the prognostic factors, and what the treatment is going to be. We need first to ask that patient, “Tell me what your life goals were before you heard that you were diagnosed with cancer.” Commonly, that patient will say, “It doesn’t matter. Just save my life.” I will say, “It does matter, and I want to know what they are, because we are hoping this will be a bump in the road, not a derailment, not a dead end.” The patient may say to me, “I’ve been married a year. My husband and I were hoping to start a family this coming year.” She’s 35 years old. If I know, based on the stage and prognostic factors, that she probably is going to be looking at chemotherapy, then I want to make sure as her nurse navigator to get a referral for her into fertility preservation. I want to preserve that life goal. I do not want to steal it away.

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perspectives on cancer care

Let’s say she is starting to be a concert pianist. I want to talk to the medical oncologist and say, “Let’s not rob her of her career goals. Let’s take a look at regimens that don’t involve drugs that will cause peripheral neuropathy. Otherwise, she won’t even be able to teach piano in her own home.” Preserving those life goals is really important.

I realize that we are facing a shortage of oncology specialists in the United States. That does not mean that the patient deserves less of the oncologist’s time. Also, it is important to assess how we can prevent side effects rather than having to fix the consequences of those side effects posttreatment. We know from research that if you power walk for 30 minutes, 5 times a week, you could reduce your fatigue during radiation by 70%. Why wouldn’t we teach patients that upfront? That just makes absolutely no sense. Also, setting them on a path of survivorship from that moment of diagnosis is really important: preserve those life goals, prevent side effects, and develop new goals they want to add when they finish their treatment. Help them create their new normal. Do not tell them they have to find a new normal or accept a new normal because they have all of these side effects that we fail to address proactively.

Q: Based on your unique perspective, what advice would you give to oncologists? LS: Because of my perspective with cancer and looking at it as a patient, a caregiver, and as an oncology nurse navigator and clinician, one of the most important things I can share with physicians is the importance of spending time with the patient. If I asked them to do only one thing while they are having a discussion, I want them to hold that patient’s hand. I want them to feel connected to this individual and not just focus on the cancer, but to look at the patient and see someone who is an individual, someone who has a life outside of the world of cancer. I also realize that we are facing a shortage of oncology specialists in the United States. That does not mean that the patient deserves less of the oncologist’s time. Oncologists really do need to identify what they need to prioritize in their discussion, and then utilize mid-level clinicians as well as nurse navigators to pick up where they have left off in doing education, psychosocial support, and barrier assessment, and then provide patients with the resources that they need. Above all, I want to make sure that the physician is talking about hope: what is this patient hoping for from the perspective of what the treatment is going to accomplish and where the patient sees his or her life going forward, including for individuals with metastatic disease. What is the patient hoping for, and how can we help that patient transition through hope? Most importantly, provide that patient a good death. That is something I will hold an oncologist responsible for. g

Call for Papers

The Journal of Oncology Navigation & Survivorship® (JONS), launched in 2010, is the nation’s first peer-reviewed clinical journal for Oncology Nurse and Patient Navigators. As this critical area of specialty and expertise grows, research and sharing of best practices are integral to both improving the clinical care of cancer patients as well as expanding the existing literature and knowledge base. Our goal at JONS is to help facilitate that growth.

Papers can be in the following forms: • Original Research • Case Study • Review Article (a synopsis/review of current • “How To” article designed to transfer successes to fellow practitioners literature in a specific area of research) Each manuscript is subject to an internal review to see that it fits the scope and mission of our journal. Papers that pass the initial review could be subject to a blind peer review; final acceptance is based on that review. If you are interested in submitting a paper or have any questions, please feel free to visit our website www.JONS-online.com or e-mail our editorial department at acooper@the-lynx-group.com.

february 2015 • Volume 6, number 1

AONNonline.org

Estrogen is a key driver of tumor growth and survival in HR+ breast cancer1,2

Mutations in the PI3K/Akt/mTOR pathway are found in

UP TO

70%

of breast cancer cases; hyperactivation of this pathway can contribute to endocrine resistance.1,3-6

CONSIDER THE KNOWN DRIVERS OF DISEASE PROGRESSION Abbreviations: Abbreviations: HR+, HR+, hormone hormone receptor-positive; receptor-positive; mTOR, PFS,mammalian progression-free targetsurvival. of rapamycin.

DOUBLE INHIBITION

In advanced disease, targeting one pathway may not be enough Aromatase inhibition

Typical ER Pathway Blockade

Estrogen

In HR+ breast cancer, NSAI treatments (eg, letrozole or anastrozole) inhibit the production of estrogen, thereby reducing ER signaling, a key driver of tumor growth and survival in breast cancer.1,2

Nucleus Cell Proliferation and Survival Aromatase inhibition

Key Mechanism of Progression

Estrogen

P ER

In the advanced setting, multiple signaling pathways and hyperactivation of the PI3K/Akt/mTOR pathway can give tumor cells alternate pathways for progression.1,4-6

mTOR

P ER

Nucleus Cell Proliferation and Survival

Cell Proliferation and Survival

AFINITOR + exemestane

Double Inhibition

Estrogen

AFINITOR

mTOR

Cell Proliferation and Survival

In patients who have progressed on an NSAI, AFINITOR® (everolimus) Tablets plus exemestane is the only regimen to deliver dual inhibition of the ER and PI3K/Akt/mTOR signaling pathways, providing synergistic inhibition of tumor survival signaling.7-9

Nucleus

Only AFINITOR plus exemestane offers dual inhibition of the ER and mTOR pathways7 AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

Important Safety Information Noninfectious Pneumonitis: • Noninfectious pneumonitis was reported in up to 19% of patients • Manage noninfectious pneumonitis by dose reduction or treated with AFINITOR. The incidence of Common Terminology discontinuation until symptoms resolve, and consider the use of Criteria (CTC) grade 3 and 4 noninfectious pneumonitis was up corticosteroids. For patients who require use of corticosteroids, to 4.0% and up to 0.2%, respectively. Fatal outcomes have been prophylaxis for PJP may be considered observed. Monitor for clinical symptoms or radiological changes • The development of pneumonitis has been reported even at a • Opportunistic infections such as pneumocystis jiroveci pneumonia reduced dose (PJP) should be considered in the differential diagnosis Abbreviations: BOLERO-2, Breast Cancer Trials of Oral Everolimus-2; ER, estrogen receptor; HR+, hormone receptor-positive; mTOR, mammalian target of rapamycin; NSAI, nonsteroidal aromatase inhibitor; P, phosphorylation; PFS, progression-free survival.

DOUBLE MEDIAN PFS AFINITOR plus exemestane more than doubled median PFS over exemestane alone7

55%

Median PFS in BOLERO-2 (Investigator Radiological Review)7 100

reduction in risk of progression or death 7

HR=0.45 [95% CI, 0.38-0.54] Log-rank P value: <0.0001

PFS curves

began to diverge at

6 weeks

(the first tumor assessment)7,9

PFS Probability (%)

Median PFS

7.8 months

[95% CI, 6.9-8.5] Median PFS

3.2 months

[95% CI, 2.8-4.1]

0 0

Time (months) AFINITOR plus exemestane (n/N=310/485)

Exemestane plus placebo (n/N=200/239)

62% reduction in risk of progression or death 7

Independent central assessment confirmed benefit 7 Median PFS was 11.0 months with AFINITOR plus exemestane [95% CI, 9.7-15.0] vs 4.1 months with placebo plus exemestane [95% CI, 2.9-5.6] (HR=0.38 [95% CI, 0.3-0.5]; P<0.0001)7

Important Safety Information (cont) Infections: • AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections (including those with opportunistic pathogens) • Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections; invasive fungal infections such as aspergillosis, candidiasis, or PJP; and viral infections, including reactivation of hepatitis B virus, have occurred. Some of these infections have been severe (eg, leading to sepsis, respiratory failure, or hepatic failure) or fatal • Physicians and patients should be aware of the increased risk of infection with AFINITOR. Treatment of preexisting invasive fungal infections should be completed prior to starting treatment with AFINITOR Please see additional Important Safety Information and Brief Summary of Prescribing Information on adjacent pages.

• Be vigilant for signs and symptoms of infection and institute appropriate treatment promptly; interruption or discontinuation of AFINITOR should be considered • Discontinue AFINITOR if invasive systemic fungal infection is diagnosed and institute appropriate antifungal treatment • PJP has been reported in patients who received everolimus, sometimes with a fatal outcome. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents; consider prophylaxis for PJP when concomitant use of these agents is required

Important Safety Information . AFINITOR® (everolimus) Tablets is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients. Noninfectious Pneumonitis: • Noninfectious pneumonitis was reported in up to 19% of patients treated with AFINITOR. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 noninfectious pneumonitis was up to 4.0% and up to 0.2%, respectively. Fatal outcomes have been observed. Monitor for clinical symptoms or radiological changes • Opportunistic infections such as pneumocystis jiroveci pneumonia (PJP) should be considered in the differential diagnosis • Manage noninfectious pneumonitis by dose reduction or discontinuation until symptoms resolve, and consider the use of corticosteroids. For patients who require use of corticosteroids, prophylaxis for PJP may be considered • The development of pneumonitis has been reported even at a reduced dose Infections: • AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections (including those with opportunistic pathogens) • Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections; invasive fungal infections such as aspergillosis, candidiasis, or PJP; and viral infections, including reactivation of hepatitis B virus, have occurred. Some of these infections have been severe (eg, leading to sepsis, respiratory failure, or hepatic failure) or fatal • Physicians and patients should be aware of the increased risk of infection with AFINITOR. Treatment of preexisting invasive fungal infections should be completed prior to starting treatment with AFINITOR • Be vigilant for signs and symptoms of infection and institute appropriate treatment promptly; interruption or discontinuation of AFINITOR should be considered • Discontinue AFINITOR if invasive systemic fungal infection is diagnosed and institute appropriate antifungal treatment • PJP has been reported in patients who received everolimus, sometimes with a fatal outcome. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents; consider prophylaxis for PJP when concomitant use of these agents is required Oral Ulceration: • Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with AFINITOR at an incidence ranging from 44% to 78% across the clinical trial experience. Grade 3/4 stomatitis was reported in 4% to 9% of patients • In such cases, topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine-, or thyme-containing mouthwashes should be avoided • Antifungal agents should not be used unless fungal infection has been diagnosed

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

Renal Failure: • Cases of renal failure (including acute renal

failure), some with a fatal outcome, have been observed in patients treated with AFINITOR Impaired Wound Healing: • Everolimus delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma • These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR in the perisurgical period Geriatric Patients: • In the randomized advanced hormone receptor-positive, HER2-negative breast cancer study, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥65 years of age compared with 2% in patients <65 years of age • Adverse reactions leading to permanent discontinuation occurred in 33% of patients ≥65 years of age compared with 17% in patients <65 years of age • Careful monitoring and appropriate dose adjustments for adverse reactions are recommended Laboratory Tests and Monitoring: • Elevations of serum creatinine and proteinuria have been reported. Renal function (including measurement of blood urea nitrogen, urinary protein, or serum creatinine) should be evaluated prior to treatment and periodically thereafter, particularly in patients who have additional risk factors that may further impair renal function • Hyperglycemia, hyperlipidemia, and hypertriglyceridemia have been reported. Blood glucose and lipids should be evaluated prior to treatment and periodically thereafter. More frequent monitoring is recommended when AFINITOR is coadministered with other drugs that may induce hyperglycemia. Management with appropriate medical therapy is recommended. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR • Reductions in hemoglobin, lymphocytes, neutrophils, and platelets have been reported. Monitoring of complete blood count is recommended prior to treatment and periodically thereafter Drug-Drug Interactions: • Avoid coadministration with strong CYP3A4/PgP inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) • Use caution and reduce the AFINITOR dose to 2.5 mg daily if coadministration with a moderate CYP3A4/PgP inhibitor is required (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem) • Avoid coadministration with strong CYP3A4/PgP inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if coadministration is required, consider doubling the daily dose of AFINITOR using increments of 5 mg or less

Hepatic Impairment:

• Exposure to everolimus was increased in

patients with hepatic impairment

• For patients with severe hepatic impairment

(Child-Pugh class C), AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended Vaccinations: • The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR Embryo-Fetal Toxicity: • Fetal harm can occur if AFINITOR is administered to a pregnant woman. Advise female patients of reproductive potential to use highly effective contraception while using AFINITOR and for up to 8 weeks after ending treatment Adverse Reactions: • The most common adverse reactions (incidence ≥30%) were stomatitis (67%), infections (50%), rash (39%), fatigue (36%), diarrhea (33%), and decreased appetite (30%) • The most common grade 3/4 adverse reactions (incidence ≥2%) were stomatitis (8%), infections (5%), hyperglycemia (5%), fatigue (4%), dyspnea (4%), pneumonitis (4%), and diarrhea (2%) Laboratory Abnormalities: • The most common laboratory abnormalities (incidence ≥50%) were hypercholesterolemia (70%), hyperglycemia (69%), increased aspartate transaminase (AST, 69%), anemia (68%), leukopenia (58%), thrombocytopenia (54%), lymphopenia (54%), increased alanine transaminase (ALT, 51%), and hypertriglyceridemia (50%) • The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia (12%), hyperglycemia (9%), anemia (7%), decreased potassium (4%), increased AST (4%), increased ALT (4%), and thrombocytopenia (3%) Please see Brief Summary of Prescribing Information on adjacent pages. To learn more, please visit www.AFINITOR.com. References: 1. Johnston SRD. Enhancing the efficacy of hormonal agents with selected targeted agents. Clin Breast Cancer. 2009; 9(suppl 1):S28-S36. 2. Miller TW, Hennessy BI, González-Angulo AM, et al. Hyperactivation of phosphatidylinositol-3 kinase promotes escape from hormone dependence in estrogen receptor-positive human breast cancer. J Clin Invest. 2010;120(7):2406-2413. 3. Miller TW, Rexer BN, Garrett JT, Arteaga CL. Mutations in the phosphatidylinositol 3-kinase pathway: role in tumor progression and therapeutic implications in breast cancer. Breast Cancer Res. 2011;13(6):224. 4. Di Cosimo S, Baselga J. Management of breast cancer with targeted agents: importance of heterogeneity. Nat Rev Clin Oncol. 2010;7(3):139-147. 5. Shou J, Massarweh S, Osborne CK, et al. Mechanisms of tamoxifen resistance: increased estrogen receptor-HER2/neu cross-talk in ER/ HER2-positive breast cancer. J Natl Cancer Inst. 2004;96(12):926-935. 6. De Laurentiis M, Arpino G, Massarelli G, et al. A meta-analysis on the interaction between HER-2 expression and response to endocrine treatment in advanced breast cancer. Clin Cancer Res. 2005;11(13): 4741-4748. 7. AFINITOR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014. 8. Fedele P, Calvani N, Marino A, et al. Targeted agents to reverse resistance to endocrine therapy in metastatic breast cancer: where are we now and where are we going? Crit Rev Oncol Hematol. 2012;84:243-251. 9. Data on file. AFINITOR CRAD001Y2301 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2012.

8/14

AFB-1095818

AFINITOR® (everolimus) tablets for oral administration Initial U.S. Approval: 2009 Brief Summary of Prescribing Information. See full prescribing information for complete product information. 1 INDICATIONS AND USAGE AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. 4 CONTRAINDICATIONS AFINITOR is contraindicated in patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives. 5 WARNINGS AND PRECAUTIONS Non-infectious Pneumonitis Non-infectious pneumonitis is a class effect of rapamycin derivatives, including AFINITOR. Non-infectious pneumonitis was reported in up to 19% of patients treated with AFINITOR in clinical trials. The incidence of Common Terminology Criteria (CTC) Grade 3 and 4 non-infectious pneumonitis was up to 4.0% and up to 0.2%, respectively [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Fatal outcomes have been observed. Consider a diagnosis of non-infectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Opportunistic infections such as pneumocystis jiroveci pneumonia (PJP) should be considered in differential diagnosis. Advise patients to report promptly any new or worsening respiratory symptoms. Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue AFINITOR therapy without dose alteration. Imaging appears to overestimate the incidence of clinical pneumonitis. If symptoms are moderate, consider interrupting therapy until symptoms improve. The use of corticosteroids may be indicated. AFINITOR may be reintroduced at a daily dose approximately 50% lower than the dose previously administered [see Table 1 in Dosage and Administration (2.2) in the full prescribing information].

T:10.875”

B:11.125”

S:9.875”

For cases of Grade 3 non-infectious pneumonitis interrupt AFINITOR until resolution to less than or equal to Grade 1. AFINITOR may be re-introduced at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances [see Dosage and Administration (2.2) in the full prescribing information]. If toxicity recurs at Grade 3, consider discontinuation of AFINITOR. For cases of Grade 4 non-infectious pneumonitis, discontinue AFINITOR. Corticosteroids may be indicated until clinical symptoms resolve. For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP may be considered. The development of pneumonitis has been reported even at a reduced dose.

Infections AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections, including infections with opportunistic pathogens [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections, invasive fungal infections, such as aspergillosis, candidiasis, or pneumocystis jiroveci pneumonia (PJP) and viral infections including reactivation of hepatitis B virus have occurred in patients taking AFINITOR. Some of these infections have been severe (e.g., leading to sepsis, respiratory or hepatic failure) or fatal. Physicians and patients should be aware of the increased risk of infection with AFINITOR. Complete treatment of pre-existing invasive fungal infections prior to starting treatment with AFINITOR. While taking AFINITOR, be vigilant for signs and symptoms of infection; if a diagnosis of an infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of AFINITOR. If a diagnosis of invasive systemic fungal infection is made, discontinue AFINITOR and treat with appropriate antifungal therapy. Pneumocystis jiroveci pneumonia, some with a fatal outcome, has been reported in patients who received everolimus. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Phophylaxis for PJP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required. Oral Ulceration Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with AFINITOR at an incidence ranging from 44%-78% across the clinical trial experience. Grade 3 or 4 stomatitis was reported in 4%-9% of patients [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. In such cases, topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine-, or thymecontaining mouthwashes should be avoided as they may exacerbate the condition. Antifungal agents should not be used unless fungal infection has been diagnosed [see Drug Interactions]. Renal Failure Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR [see Laboratory Tests and Monitoring].

Impaired Wound Healing Everolimus delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma. These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR in the peri-surgical period. Geriatric Patients In the randomized advanced hormone receptor-positive, HER2-negative breast cancer study, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥ 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients ≥ 65 years of age compared to 17% in patients < 65 years of age. Careful monitoring and appropriate dose adjustments for adverse reactions are recommended [see Dosage and Administration (2.2) in the full prescribing information and Use in Specific Populations]. Laboratory Tests and Monitoring Renal Function Elevations of serum creatinine and proteinuria have been reported in patients taking AFINITOR [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein, or serum creatinine, is recommended prior to the start of AFINITOR therapy and periodically thereafter. Renal function of patients should be monitored particularly where patients have additional risk factors that may further impair renal function. Blood Glucose and Lipids Hyperglycemia, hyperlipidemia, and hypertriglyceridemia have been reported in patients taking AFINITOR [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Monitoring of fasting serum glucose and lipid profile is recommended prior to the start of AFINITOR therapy and periodically thereafter as well as management with appropriate medical therapy. More frequent monitoring is recommended when AFINITOR is co-administered with other drugs that may induce hyperglycemia. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR. Hematologic Parameters Decreased hemoglobin, lymphocytes, neutrophils, and platelets have been reported in patients taking AFINITOR [see Adverse Reactions (6.1, 6.2, 6.3, 6.4, 6.5) in the full prescribing information]. Monitoring of complete blood count is recommended prior to the start of AFINITOR therapy and periodically thereafter. Drug-drug Interactions Due to significant increases in exposure of everolimus, co-administration with strong CYP3A4/PgP inhibitors should be avoided [see Dosage and Administration (2.2, 2.5) in the full prescribing information and Drug Interactions]. A reduction of the AFINITOR dose is recommended when co-administered with a moderate CYP3A4/PgP inhibitor [see Dosage and Administration (2.2, 2.5) in the full prescribing information and Drug Interactions]. An increase in the AFINITOR dose is recommended when co-administered with a strong CYP3A4/PgP inducer [see Dosage and Administration (2.2, 2.5) in the full prescribing information and Drug Interactions]. Hepatic Impairment Exposure to everolimus was increased in patients with hepatic impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. For advanced HR+ BC, advanced PNET, advanced RCC, and renal angiomyolipoma with TSC patients with severe hepatic impairment (Child-Pugh class C), AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in the full prescribing information]. For patients with SEGA and mild or moderate hepatic impairment, adjust the dose of AFINITOR Tablets or AFINITOR DISPERZ based on therapeutic drug monitoring. For patients with SEGA and severe hepatic impairment, reduce the starting dose of AFINITOR Tablets or AFINITOR DISPERZ by approximately 50% and adjust subsequent doses based on therapeutic drug monitoring [see Dosage and Administration (2.4, 2.5) in the full prescribing information]. Vaccinations During AFINITOR treatment, avoid the use of live vaccines and avoid close contact with individuals who have received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines). Embryo-fetal Toxicity Based on the mechanism of action, AFINITOR can cause fetal harm. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations]. Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception while using AFINITOR and for up to 8 weeks after ending treatment [see Use in Specific Populations]. 6 ADVERSE REACTIONS The efficacy and safety of AFINITOR (10 mg/day) plus exemestane (25 mg/day) (n=485) versus placebo plus exemestane (25 mg/day) (n=239) was evaluated in a randomized, controlled trial in patients with advanced or metastatic hormone receptor-positive,

Table 3: Key Laboratory Abnormalities Reported in ≥ 10% of Patients with Advanced HR+ BC

HER2-negative breast cancer. The median age of patients was 61 years (range 28-93 years), and 75% were Caucasian. Safety results are based on a median follow-up of approximately 13 months. The most common adverse reactions (incidence ≥ 30%) were stomatitis, infections, rash, fatigue, diarrhea, and decreased appetite. The most common Grade 3/4 adverse reactions (incidence ≥ 2%) were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis, and diarrhea. The most common laboratory abnormalities (incidence ≥ 50%) were hypercholesterolemia, hyperglycemia, increased aspartate transaminase (AST), anemia, leukopenia, thrombocytopenia, lymphopenia, increased alanine transaminase (ALT), and hypertriglyceridemia. The most common Grade 3/4 laboratory abnormalities (incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, decreased potassium, increased AST, increased ALT, and thrombocytopenia. Fatal adverse reactions occurred more frequently in patients who received AFINITOR plus exemestane (2%) compared to patients on the placebo plus exemestane arm (0.4%). The rates of treatment-emergent adverse events resulting in permanent discontinuation were 24% and 5% for the AFINITOR plus exemestane and placebo plus exemestane treatment groups, respectively. Dose adjustments (interruptions or reductions) were more frequent among patients in the AFINITOR plus exemestane arm than in the placebo plus exemestane arm (63% versus 14%). Table 2 compares the incidence of treatment-emergent adverse reactions reported with an incidence of ≥10% for patients receiving AFINITOR 10 mg daily versus placebo. Table 2: Adverse Reactions Reported ≥ 10% of Patients with Advanced HR+ BC* AFINITOR (10 mg/day) Placebo + exemestanea + exemestanea N=482 N=238 All grades Grade 3 Grade 4 All grades Grade 3 Grade 4 % % % % % % Any adverse reaction 100 41 9 Gastrointestinal disorders Stomatitisb 67 8 0 Diarrhea 33 2 0.2 Nausea 29 0.2 0.2 Vomiting 17 0.8 0.2 Constipation 14 0.4 0 Dry mouth 11 0 0 General disorders and administration site conditions Fatigue 36 4 0.4 Edema peripheral 19 1 0 Pyrexia 15 0.2 0 Asthenia 13 2 0.2 Infections and infestations c Infections 50 4 1 Investigations Weight decreased 25 1 0 Metabolism and nutrition disorders Decreased appetite 30 1 0 Hyperglycemia 14 5 0.4 Musculoskeletal and connective tissue disorders Arthralgia 20 0.8 0 Back pain 14 0.2 0 Pain in extremity 9 0.4 0 Nervous system disorders Dysgeusia 22 0.2 0 Headache 21 0.4 0 Psychiatric disorders Insomnia 13 0.2 0 Respiratory, thoracic and mediastinal disorders Cough 24 0.6 0 Dyspnea 21 4 0.2 Epistaxis 17 0 0 Pneumonitisd 19 4 0.2 Skin and subcutaneous tissue disorders Rash 39 1 0 Pruritus 13 0.2 0 Alopecia 10 0 0 Vascular disorders Hot flush 6 0 0 Median duration of treatmente

11 18 28 12 13 7

0.8 0.8 1 0.8 0.4 0

0 0 0 0 0 0

27 6 7 4

1 0.4 0.4 0

0 0 0 0

12 2

0.4 0.4

0 0

17 10 11

0 0.8 2

0 0 0

6 14

0 0

12 11 1 0.4

0 0.8 0 0

0 0.4 0 0

6 5 5

0 0 0

23.9 weeks

13.4 weeks

Grading according to CTCAE Version 3.0 *160 patients (33.2%) were exposed to AFINITOR therapy for a period of ≥ 32 weeks) Exemestane (25 mg/day) Includes stomatitis, mouth ulceration, aphthous stomatitis, glossodynia, gingival pain, glossitis and lip ulceration c Includes all preferred terms within the ‘infections and infestations’ system organ class, the most common being nasopharyngitis (10%), urinary tract infection (10%), upper respiratory tract infection (5%), pneumonia (4%), bronchitis (4%), cystitis (3%), sinusitis (3%), and also including candidiasis (<1%), and sepsis (<1%), and hepatitis C (<1%). d Includes pneumonitis, interstitial lung disease, lung infiltration, and pulmonary fibrosis e Exposure to AFINITOR or placebo a

Key observed laboratory abnormalities are presented in Table 3.

Laboratory parameter

AFINITOR (10 mg/day) Placebo + exemestanea + exemestanea N=482 N=238 All grades Grade 3 Grade 4 All grades Grade 3 Grade 4 % % % % % %

Hematologyb Hemoglobin decreased WBC decreased Platelets decreased Lymphocytes decreased Neutrophils decreased Clinical chemistry Glucose increased Cholesterol increased Aspartate transaminase (AST) increased Alanine transaminase (ALT) increased Triglycerides increased Albumin decreased Potassium decreased Creatinine increased

68 58 54 54 31

6 1 3 11 2

0.6 0 0.2 0.6 0

40 28 5 37 11

0.8 5 0 5 0.8

0.4 0.8 0.4 0.8 0.8

69 70 69

9 0.6 4

0.4 0.2 0.2

44 38 45

0.8 0.8 3

0.4 0.8 0.4

0.2

50 33 29 24

0.8 0.8 4 2

0 0 0.2 0.2

26 16 7 13

0 0.8 1 0

0 0 0 0

Grading according to CTCAE Version 3.0 a Exemestane (25 mg/day) b Reflects corresponding adverse drug reaction reports of anemia, leukopenia, lymphopenia, neutropenia, and thrombocytopenia (collectively as pancytopenia), which occurred at lower frequency. 7 DRUG INTERACTIONS Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of the multidrug efflux pump PgP. In vitro, everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6. Agents That May Increase Everolimus Blood Concentrations CYP3A4 Inhibitors and PgP Inhibitors In healthy subjects, compared to AFINITOR treatment alone there were significant increases in everolimus exposure when AFINITOR was coadministered with: • ketoconazole (a strong CYP3A4 inhibitor and a PgP inhibitor) - Cmax and AUC increased by 3.9- and 15.0-fold, respectively. • erythromycin (a moderate CYP3A4 inhibitor and a PgP inhibitor) - Cmax and AUC increased by 2.0- and 4.4-fold, respectively. • verapamil (a moderate CYP3A4 inhibitor and a PgP inhibitor) - Cmax and AUC increased by 2.3- and 3.5-fold, respectively. Concomitant strong inhibitors of CYP3A4/PgP should not be used [see Dosage and Administration (2.2, 2.5) in the full prescribing information and Warnings and Precautions]. Use caution when AFINITOR is used in combination with moderate CYP3A4/PgP inhibitors. If alternative treatment cannot be administered reduce the AFINITOR dose [see Dosage and Administration (2.2, 2.5) in the full prescribing information and Warnings and Precautions]. Agents That May Decrease Everolimus Blood Concentrations CYP3A4/PgP Inducers In healthy subjects, co-administration of AFINITOR with rifampin, a strong inducer of CYP3A4 and an inducer of PgP, decreased everolimus AUC and Cmax by 63% and 58% respectively, compared to everolimus treatment alone. Consider a dose increase of AFINITOR when co-administered with strong CYP3A4/PgP inducers if alternative treatment cannot be administered. St. John’s Wort may decrease everolimus exposure unpredictably and should be avoided [see Dosage and Administration (2.2, 2.5) in the full prescribing information]. Drugs That May Have Their Plasma Concentrations Altered by Everolimus Studies in healthy subjects indicate that there are no clinically significant pharmacokinetic interactions between AFINITOR and the HMG-CoA reductase inhibitors atorvastatin (a CYP3A4 substrate) and pravastatin (a non-CYP3A4 substrate) and population pharmacokinetic analyses also detected no influence of simvastatin (a CYP3A4 substrate) on the clearance of AFINITOR. A study in healthy subjects demonstrated that co-administration of an oral dose of midazolam (sensitive CYP3A4 substrate) with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf). Coadministration of everolimus and exemestane increased exemestane Cmin by 45% and C2h by 64%. However, the corresponding estradiol levels at steady state (4 weeks) were not different between the 2 treatment arms. No increase in adverse events related to exemestane was observed in patients with hormone receptor-positive, HER2-negative advanced breast cancer receiving the combination. Coadministration of everolimus and depot octreotide increased octreotide Cmin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category D

Risk Summary Based on the mechanism of action, AFINITOR can cause fetal harm when administered to a pregnant woman. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures. If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, apprise the patient of the potential hazard to the fetus [see Warnings and Precautions]. Animal Data In animal reproductive studies, oral administration of everolimus to female rats before mating and through organogenesis induced embryo-fetal toxicities, including increased resorption, pre-implantation and post-implantation loss, decreased numbers of live fetuses, malformation (e.g., sternal cleft), and retarded skeletal development. These effects occurred in the absence of maternal toxicities. Embryo-fetal toxicities in rats occurred at doses ≥ 0.1 mg/kg (0.6 mg/m2) with resulting exposures of approximately 4% of the exposure (AUC0-24h) achieved in patients receiving the 10 mg daily dose of everolimus. In rabbits, embryotoxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg (9.6 mg/m2), approximately 1.6 times either the 10 mg daily dose or the median dose administered to SEGA patients on a body surface area basis. The effect in rabbits occurred in the presence of maternal toxicities. In a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. At the dose of 0.1 mg/kg (0.6 mg/m2), there were no adverse effects on delivery and lactation or signs of maternal toxicity; however, there were reductions in body weight (up to 9% reduction from the control) and in survival of offspring (~5% died or missing). There were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring. Nursing Mothers It is not known whether everolimus is excreted in human milk. Everolimus and/or its metabolites passed into the milk of lactating rats at a concentration 3.5 times higher than in maternal serum. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from everolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Pediatric use of AFINITOR Tablets and AFINITOR DISPERZ is recommended for patients 1 year of age and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. The safety and effectiveness of AFINITOR Tablets and AFINITOR DISPERZ have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA. The effectiveness of AFINITOR in pediatric patients with SEGA was demonstrated in two clinical trials based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume [see Clinical Studies (14.5) in the full prescribing information]. Improvement in disease-related symptoms and overall survival in pediatric patients with SEGA has not been demonstrated. The long term effects of AFINITOR on growth and pubertal development are unknown. Study 1 was a randomized, double-blind, multicenter trial comparing AFINITOR (n=78) to placebo (n=39) in pediatric and adult patients. The median age was 9.5 years (range 0.8 to 26 years). At the time of randomization, a total of 20 patients were < 3 years of age, 54 patients were 3 to < 12 years of age, 27 patients were 12 to < 18 years of age, and 16 patients were ≥ 18 years of age. The overall nature, type, and frequency of adverse reactions across the age groups evaluated were similar, with the exception of a higher per patient incidence of infectious serious adverse events in patients < 3 years of age. A total of 6 of 13 patients (46%) < 3 years of age had at least 1 serious adverse event due to infection, compared to 2 of 7 patients (29%) treated with placebo. No patient in any age group discontinued AFINITOR due to infection [see Adverse Reactions (6.5) in the full prescribing information]. Subgroup analyses showed reduction in SEGA volume with AFINITOR treatment in all pediatric age subgroups. Study 2 was an open-label, single-arm, single-center trial of AFINITOR (N=28) in patients aged ≥ 3 years; median age was 11 years (range 3 to 34 years). A total of 16 patients were 3 to < 12 years, 6 patients were 12 to < 18 years, and 6 patients were ≥ 18 years. The frequency of adverse reactions across the age groups was generally similar [see Adverse Reactions (6.5) in the full prescribing information]. Subgroup analyses showed reductions in SEGA volume with AFINITOR treatment in all pediatric age subgroups. Everolimus clearance normalized to body surface area was higher in pediatric patients than in adults with SEGA [see Clinical Pharmacology (12.3) in the full prescribing information]. The recommended starting dose and subsequent requirement for therapeutic drug monitoring to achieve and maintain trough concentrations of 5 to 15 ng/mL are the same for adult and pediatric patients with SEGA [see Dosage and Administration (2.3, 2.4) in the full prescribing information]. Geriatric Use In the randomized advanced hormone receptor positive, HER2-negative breast cancer study, 40% of AFINITOR-treated patients were ≥ 65 years of age, while 15% were 75 years and over. No overall differences in effectiveness were observed between elderly and younger patients. The incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥ 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients ≥ 65 years of age compared to 17% in patients < 65 years of age [see Warnings and Precautions].

In two other randomized trials (advanced renal cell carcinoma and advanced neuroendocrine tumors of pancreatic origin), no overall differences in safety or effectiveness were observed between elderly and younger patients. In the randomized advanced RCC study, 41% of AFINITOR treated patients were ≥ 65 years of age, while 7% were 75 years and over. In the randomized advanced PNET study, 30% of AFINITOR-treated patients were ≥ 65 years of age, while 7% were 75 years and over. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) in the full prescribing information]. No dosage adjustment in initial dosing is required in elderly patients, but close monitoring and appropriate dose adjustments for adverse reactions is recommended [see Dosage and Administration (2.2), Clinical Pharmacology (12.3) in the full prescribing information]. Females and Males of Reproductive Potential Contraception Females AFINITOR can cause fetal harm when administered to a pregnant woman. Advise female patients of reproductive potential to use highly effective contraception while receiving AFINITOR and for up to 8 weeks after ending treatment [see Use in Specific Populations]. Infertility Females Menstrual irregularities, secondary amenorrhea, and increases in luteinizing hormone (LH) and follicle stimulating hormone (FSH) occurred in female patients taking AFINITOR. Based on these clinical findings and findings in animals, female fertility may be compromised by treatment with AFINITOR [see Adverse Reactions (6.2, 6.4, 6.5) and Nonclinical Toxicology in the full prescribing information]. Males AFINITOR treatment may impair fertility in male patients based on animal findings [see Nonclinical Toxicology in the full prescribing information]. Renal Impairment No clinical studies were conducted with AFINITOR in patients with decreased renal function. Renal impairment is not expected to influence drug exposure and no dosage adjustment of everolimus is recommended in patients with renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. Hepatic Impairment The safety, tolerability and pharmacokinetics of AFINITOR were evaluated in a 34 subject single oral dose study of everolimus in subjects with impaired hepatic function relative to subjects with normal hepatic function. Exposure was increased in patients with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. For advanced HR+ BC, advanced PNET, advanced RCC, and renal angiomyolipoma with TSC patients with severe hepatic impairment, AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended [see Dosage and Administration (2.2) in the full prescribing information]. For patients with SEGA who have severe hepatic impairment (Child-Pugh class C), reduce the starting dose of AFINITOR Tablets or AFINITOR DISPERZ by approximately 50%. For patients with SEGA who have mild (Child-Pugh class A) or moderate (ChildPugh class B) hepatic impairment, adjustment to the starting dose may not be needed. Subsequent dosing should be based on therapeutic drug monitoring [see Dosage and Administration (2.4, 2.5) in the full prescribing information]. 10 OVERDOSAGE In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity was observed in either mice or rats given single oral doses of 2000 mg/kg (limit test). Reported experience with overdose in humans is very limited. Single doses of up to 70 mg have been administered. The acute toxicity profile observed with the 70 mg dose was consistent with that for the 10 mg dose. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Revised Feb 2014 © Novartis T2014-66/T2014-17 July 2014/February 2014

Clinical trial tracker

New Clinical Trials Under Way The following clinical trials are currently recruiting patients with small-cell lung cancer or non–small-cell lung cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Erlotinib With or Without Bevacizumab

The objective of this phase 2 study is to examine the efficacy of erlotinib with or without bevacizumab in patients with stage IV non–small-cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients aged ≥18 years with a life expectancy of ≥12 months, an Eastern Cooperative Oncology Group performance status 0 or 1, and a hemoglobin level of ≥9.0 g/dL may enroll if other criteria are met. Erlotinib is given orally once daily to both the comparator and experimental arms on days 1 through 21, and patients in the experimental arm receive a dose of intravenous bevacizumab for 30 to 90 minutes on day 1. Courses are repeated every 21 days for both arms until disease progression or unacceptable toxicity becomes evident. Patients are followed periodically for up to 5 years after study completion. The primary outcome is progression-free survival of patients with EGFR mutations being treated with erlotinib in combination with bevacizumab versus erlotinib alone. Secondary outcomes include overall rate of survival, complete or partial response rate to each treatment method, adverse events, and progression-free survival of patients with other mutation types. This study expects to enroll 118 patients in multiple locations across the United States. For more information, contact Thomas Stinchcombe, MD, at 919-966-4431 or thomas_stinchcombe@med.unc.edu. The NLM Identifier is NCT01532089.

Denosumab with Chemotherapy as First-Line Treatment

This phase 2, randomized, double-blind study aims to study the effect of combining denosumab with standard chemotherapy in the treatment of patients with advanced lung cancer. Patients aged ≥18 years with stage IV, untreated non–small-cell lung cancer with or without bone metastasis may enroll if other inclusion criteria are met. Randomization occurs in a 2-to-1 ratio of patients receiving denosumab 120 mg to matching placebo subcutaneously every 3 or 4 weeks plus a loading dose on day 8 of the study. The first investigational product dose coincides with the

february 2015 • Volume 6, number 1

patient’s first cycle of chemotherapy. Treatment continues until the time of the primary analysis, the patient is lost to follow-up, or the patient dies. All patients will receive daily dietary supplements of ≥500 mg of calcium and ≥400 IU of vitamin D. The primary outcome is the relative benefit on overall survival of receiving denosumab in combination with standard of care (SOC) versus SOC alone. The secondary outcomes aim to correlate tumor tissue RANK and RANKL expression with the objective response rate and/or overall survival. Serum denosumab trough levels, and safety and tolerability of denosumab are measured. The study expects to enroll 216 patients and will take place in multiple locations across the United States, including California, New York, and Tennessee. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT01951586.

Safety and Efficacy of Adding Talactoferrin to Standard Chemotherapy

This is a phase 3, double-blind, safety and efficacy study comparing the combination of talactoferrin, carboplatin, and paclitaxel with the combination of paclitaxel and carboplatin in improving progression-free survival and overall survival in patients with non–small-cell lung cancer. Patients aged ≥18 years with at least 1 target lesion measurable by Response Evaluation Criteria in Solid Tumors are eligible if other criteria are met. In addition to carboplatin and paclitaxel, patients will receive 1.5 grams of twice- daily placebo or talactoferrin. The primary outcomes are overall and progression-free survival, and the secondary outcome measures include safety and tolerability, as well as objective response and disease stabilization rates. The study plans to enroll 1100 patients. For more information, contact Yenyun Wang, MD, at 713-552-1091 or ywang@agennix.com, or Rajesh Malik, MD, at 713-552-1091 or rmalik@agennix.com. The NLM Identifier is NCT00706862.

Bavituximab plus Docetaxel versus Docetaxel plus Placebo

The purpose of this phase 3, double-blind study is to assess whether adding bavituximab to docetaxel will improve the results of treatment for patients with non–small-cell lung cancer (NSCLC). Patients must be aged ≥18 years, have histologic evidence of stage IIIB or IV nonsquamous NSCLC, have radiographic disease progression or recur-

AONNonline.org

Clinical trial tracker

rence during or after first-line, platinum-based doublet chemotherapy, and meet other criteria to enroll. Patients will receive docetaxel for 6, 21-day cycles with either bavituximab or a placebo on a weekly basis in the absence of disease progression. The primary outcome is overall survival. Secondary outcomes include progression-free survival, overall response rate, and safety as measured by adverse event rates and laboratory procedures. The outcomes have a time frame of approximately 36 months. The study is expected to enroll 582 patients and be conducted at multiple locations across the United States, including Arizona, Oregon, and Wisconsin. For further information, contact Jennifer Lai, MBA, at 855-291-7867 or lungcancertrial@peregrineinc. com. The NLM Identifier is NCT01999673.

placebo. Treatment is given once a day orally on days 1 through 21, and repeated every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. The primary outcome is overall survival from time of randomization until time of death, with up to 5 years of assessment. Secondary outcomes include disease-free survival at a 2-year follow-up, overall survival rate defined as the proportion of patients alive 5 years after the date of randomization, and incidence of adverse events associated with each study group. The study expects to enroll 450 patients in multiple locations across the United States, including Iowa, Maryland, and Nevada. For more information, contact Ramaswamy Govindan, MD, at 314-3625737 or rgovinda@dom.wustl.edu. The NLM Identifier is NCT02193282.

Carfilzomib with Irinotecan for IrinotecanSensitive Malignancies

Nintedanib for Advanced NSCLC

This is a phase 1b/2 trial. Phase 1b is an open-label study determining the maximum tolerated dose of carfilz omib in combination with irinotecan in patients with relapsed small-cell lung cancer (SCLC) and non–smallcell lung cancer (NSCLC) or other irinotecan-sensitive cancers. Phase 2 assesses the 6-month survival of patients with relapsed SCLC treated with carfilzomib in combination with irinotecan. Secondary outcomes include response rate, progression-free survival, safety and tolerability, and rates of specified adverse events for a time frame of up to 6 months. Phase 1b includes patients with advanced SCLC or NSCLC, or other cancers where irinotecan therapy has shown efficacy and for whom no curative therapy exists. Phase 2 includes patients with advanced-stage SCLC with progression or recurrence following 1 platinum-containing regimen. The trial plans to enroll 112 patients. For more information, contact Susanne M. Arnold, MD, at 859323-8043 or smarno0@uky.edu, or Grace Powell, BA, at 206-839-1790 or gracep@crab.org. The NLM Identifier is NCT01941316.

Erlotinib Hydrochloride for Surgery-Removed Stage IB-II-IIIA NSCLC

The objective of this phase 3, randomized study is to determine the efficacy of erlotinib hydrochloride in treating patients with stage IB, II, and IIIA non–small-cell lung cancer (NSCLC) that has been completely removed by surgery. Patients aged ≥18 years with completely resected stage IB to IIIA NSCLC with negative margins who meet additional inclusion criteria may enroll in the study. Patients are randomized to either erlotinib hydrochloride or

This phase 2 trial studies the efficacy of nintedanib in treating patients with advanced non–small-cell lung cancer who have failed up to 2 previous chemotherapy regimens. Patients aged ≥18 years with an Eastern Cooperative Oncology Group performance status of ≤1 may enroll if other inclusion criteria are met. All patients will receive nintedanib orally twice a day on days 1 through 28. Courses are repeated every 28 days in the absence of disease progression or unacceptable toxicity. The primary outcome is progression-free survival (PFS) rate of the fibroblast growth factor receptor 1 (FGFR1)-amplified patient group over a time frame of 6 months. The secondary outcomes include PFS rate for the FGFR1-amplified patient group compared with patients with wildtype FGFR1, PFS within each FGFR1-amplified group (low, intermediate, and high), overall survival, adverse events, and tumor response defined as partial or complete according to the Response Evaluation Criteria in Solid Tumors. This study expects to enroll 67 patients and will be conducted in New York at the Roswell Park Cancer Institute in Buffalo. For more information, contact Alex A. Adjei, MD, PhD, FACP, at 877-275-7724 or ASKRPCI@roswell park.org. The NLM Identifier is NCT01948141.

Crizotinib for Stage IB-IIIA NSCLC Removed by Surgery

This is a phase 3 study that evaluates whether crizotinib therapy adjuvant to surgical resection will result in improved overall survival (OS) compared with a placebo for patients with stage IB, II, and IIIA non–small-cell lung cancer with an anaplastic lymphoma kinase mutation. Patients aged ≥18 years without evidence of disease for 90 days in advance of randomization may enroll if other crite-

JONS-online.com journal of Oncology Navigation & Survivorship

Clinical trial tracker

ria are met. The experimental arm will receive crizotinib orally twice a day for days 1 through 21. Treatment is repeated every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. The placebo will be given in the same regimen. Primary outcomes measure OS from time of randomization to time of disease recurrence, new lung cancer appearance, or death, assessed for up to 10 years. Secondary outcomes are assessed for up to 10 years and include disease-free survival and toxicity rates measured according to the Common Terminology Criteria for Adverse Events. This study plans to enroll 378 patients and will be conducted in Philadelphia, PA. For more information, contact David E. Gerber, MD, at 214-648-7097 or david.gerber@utsouth western.edu. The NLM Identifier is NCT02201992.

TH-302 or Placebo with Pemetrexed for Nonsquamous NSCLC

This is a phase 2, randomized, double-blind study determining whether TH-302 in combination with pemetrexed is safe and effective as second-line treatment for nonsquamous non–small-cell lung cancer (NSCLC). Patients aged ≥18 years with stage IIIB or IV NSCLC with nonsquamous histology and other criteria are eligible for enrollment. Patients are randomized to either TH-302 400 mg/m2 or a matching placebo, intravenously infused for 30 to 60 minutes on day 1 and day 8 of a 21-day cycle, and pemetrexed 500 mg/m2 intravenously infused on the first day, 2 to 4 hours after administration of TH-302 or placebo. The primary outcome is the efficacy of pemetrexed in combination with TH-302 as determined by overall survival over a time frame of 2 years in patients in the second-line chemotherapy setting with advanced, nonsquamous NSCLC compared with pemetrexed in combination with placebo. Secondary outcomes include the incidence and severity of adverse events, pharmacokinetics of TH-302 in study pa-

tients, and antitumor activity between the 2 groups as measured by progression-free survival and response rates. This study expects to enroll 440 patients at multiple locations across the United States, including Colorado, California, and Kentucky. For more information, contact Kristin Williams at 860-949-5311 or kristin.williams@psi-cro.com, or Mandeep Grewal at 650-474-8361 or mgrewal@threshold pharm.com. The NLM Identifier is NCT02093962.

Custirsen for Patients with Stage IV NSCLC

This is a phase 3 study that compares the overall survival of patients receiving custirsen and docetaxel (Arm A) versus docetaxel alone (Arm B). Patients aged ≥18 years with stage IV non–small-cell lung cancer (NSCLC), a life expectancy >12 weeks from screening, and who received 1 previous line of platinum-based systemic anticancer therapy for advanced or metastatic NSCLC may enroll if other criteria are met. Both treatment arms will receive docetaxel 75 mg/m2 intravenously (IV) for 1 hour on the first day of every 21-day cycle. The experimental arm (Arm A) will also receive 3 loading doses of custirsen 640 mg IV for 2 hours administered 5 to 9 days prior to the first day of cycle 1, followed by custirsen 640 mg IV weekly every 21-day cycle. Treatment will continue until there is unacceptable toxicity, disease progression, withdrawal of consent, or protocol-specified parameters to curb treatment. The primary outcome is overall survival, defined as the time between date of randomization and date of death from any cause. Secondary outcomes include progression-free survival, rate and duration of objective response, duration and rate of disease control, and adverse events. Data are collected over 60 months. The study plans to enroll 1100 patients, and study locations include Florida, North Carolina, and Texas. For more information, contact Teva US Medical Information at 800-896-5855. The NLM Identifier is NCT01630733. g

february 2015 • Volume 6, number 1

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nquering the Cancer Ca ce our third Annua series. th re Continuum l newsletter highly rele ese publications wil l continue vant topics to first issue in focuses on oncology managem address manufacturin ent. the current goo g d pra ctic includes arti e (cGmP) and cles written oncology by a clinica pha nurse practit rmacist, an oncolo l lawyer. th ioner, and a regula gy tory ese perspe ctives, bas the faculty ed on ’s experience expertise and person , explore a al wide array sues related of regulation to this topic, includ isrted by TEVA e ons opini tion on whviewsyandhav . TEVA provi som for the app ing expre e ssed info ded the idea arerma from at drugs, the rov this article patients, scie has worked for oth -the authors and not necessarilyforthose pros and con al of novel of TEVA. counter (o available. ntific data are not usu er tC) supple s of over-theFur ally importanc ments, and there is con thermore, even wh e of carefu the firm l patient en tion in clin that certain ation through rese selecical trials. arc Fut the series wil h ure issues treatment- otC options dim inish related sym care, advanc l discuss access to qua in not know pto lity whether the ms, we do ment, the es in side effect manag will have se substan Lillie D. Sho imp an ces Care Act on act of the Afford eckn lism of the impact on the metab able RN, BS, MA ey, can opatient car cancer care, and ped S cer therap ministered iatric e. y being ad. Cli Patients ofte existing ot nical trials of new n assume C suppleme or can be pur that if a dru pensive cha nts are g or supple fied in the concerns abo sed over the counte ment current wo that few or none can so exr, rld of health vestigated be tions that ut safety, efficacy, or there should be no within a clin care. All age justicou dru of a new ica nts l tria inment or per ld negatively impact g-to-drug interacl sett Dru son that has cos g Application, a reg ing require the use cancer to ask al health. it is com their cancer treatts of ulatory com mon for pat plexity Despite the its own. ien used to dim oncology nurses wh lack of def ich otC dru ts with inish specifi otC drugs initive inf motherapy gs c and supple ormation they are rec side effects caused by can be to make rec ments, nur eiving. th the ses must be about cheommenda ere are also tions about patient sett prepared situations ing their use in recommenda . When nurses are The developm considerin the outtion, they ga and a Med ent and publication would be ical Accurac of wise to con specific y review. The this article has been sider the supported views and opin by TEV ions expresse A. TEVA prov © 2014 Gre d are from ided the the authors en Hill Hea and not nece idea for this article lthcare Com munications, ssarily thos e of TEVA. LLC

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lung cancer

Lung Cancers and Stigma: Perception or Reality? Caroline Kornhauser, MPH; Sarah Quinlan; Nian Hu; Christin Washington; Dawn Zador; Carolyn Messner, DSW, OSW-C, LCSW-R “Who can I blame? I am 67 years old and have been a heavy smoker all my life. I have lived with chronic obstructive pulmonary disease, and was just diagnosed with lung cancer. I made my bed and now I have to sleep in it.”

his patient vignette portrays the self-blame, suffering, and personal pain that a diagnosis of lung cancer may precipitate in patients who smoked cigarettes for a significant part of their life. Lung cancers are the leading cause of cancer deaths in the United States.1 “Lung cancer is classified as small cell (14%) or non small cell (84%) for the purposes of treatment. Based on type and stage of cancer, as well as specific molecular characteristics of cancer cells, treatments include surgery, radiation therapy, chemotherapy and targeted therapies.”1 However, oncology professionals often do not have the resources to address the psychosocial distress of this population. This article describes the stigma that may be associated with a lung cancer diagnosis and its impact on body image, self-perception, and coping. Also explored are ways in which this stigma may be alleviated by the multidisciplinary oncology team, with particular emphasis on the important role oncology nurses play in the care of these patients.

Recognizing Stigma

Because smoking has been identified as a risk factor in lung cancer, the disease is often viewed one-dimensionally.2 Many people associate lung cancer with smoking, believing that patients with lung cancer caused their illness through their lifestyle choices and behaviors. This view may lead to bias against these patients. In addition, the stigma of lung cancer is often internalized by patients and translates to feelings of shame, fear, and guilt.3 Some healthcare professionals unintentionally fall prey to this bias, contributing to their patients’ stigmatization. The widespread belief that smoking is the sole cause of lung cancer with the blame placed on the individual may obfuscate the suffering of people living with lung cancer.

The Physical Effects of Smoking

Patients with lung cancer face increased discrimination as a result of the physical effects of smoking. Nonsmokers

Reprinted with permission from The Oncology Nurse-APN/PA.

february 2015 • Volume 6, number 1

may be judgmental of lung cancer patients. The physical signs of smoking, including coughing, the lingering scent of smoke, and stained teeth, are often considered repulsive by nonsmokers. This perception is compounded by the media’s antismoking campaigns. Although the goal of the media is to deter people from smoking, an unanticipated consequence is to further stigmatize patients with lung cancer.

Unfounded Nature of the Lung Cancer Stigma

The many causes of lung cancer There is a proved correlation between smoking and lung cancer, but the causes of lung cancer are complex and manifold. An estimated 15% of people diagnosed with lung cancer have never smoked,4 and a total of 60% of patients are people who have either never smoked or quit years ago.5 Among cancer patients, there is a divide between the smokers and the never-smokers. Frequently, never-smokers wish not to be associated with smokers. They view themselves as having an unfair diagnosis and feel compelled to defend themselves when confronted with the stigma of lung cancer.2,6

There is a proved correlation between smoking and lung cancer, but the causes of lung cancer are complex and manifold. Lung cancer has been linked to environmental factors, including exposure to radon, asbestos, and other toxins. Exposure to radon is the second leading cause of developing lung cancer. “Genetic susceptibility plays a contributing role; especially in those who develop lung cancer at a younger age.”1 In education programs for the public about lung cancer, it is vital to include that there is a complex network of factors leading to a lung cancer diagnosis. Smoking before the health risks were known The stigma of smoking unfairly attributes blame to those who have lung cancer for allegedly self-inflicting their disease. Cigarette smoking became increasingly popular in the 1960s. At that time, people living in the United States were somewhat unaware of the long-term health risks of smoking. Only relatively recently has the public been made aware of the health risks associated with tobacco use.

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lung cancer

Caroline Kornhauser, MPH, Education Outreach Coordinator, CancerCare

Sarah Quinlan, Senior Education Technical and Marketing Coordinator, CancerCare

Nian Hu, Prep for Prep, Freshman, Harvard Class of 2018

Today, many people living with lung cancer are those who smoked at a time when smoking was not only accepted but was also considered chic and cool.2 Some of these individuals have since quit, but many live with the longterm effects of their prior lifestyle. Because of the addictive nature of tobacco, once people begin smoking, many find it difficult, if not impossible, to quit.7 Smoking is an extremely powerful addiction that is difficult to overcome because the nicotine creates a physical dependence in the smoker.8

Lung Cancer Impact and Stigma

The physical and psychosocial impact of lung cancer stigma People living with lung cancer may experience changes in their activities of daily living (ADLs). Lung cancer and its treatment may cause shortness of breath, fatigue, loss of strength, and treatment-related side effects. In addition to dealing with the physical limitations of lung cancer, patients may experience psychosocial challenges regarding their self-image and body image, often compounded by the stigma of the disease. The physical changes that arise from lung cancer and its treatment are noticeable not only to patients with cancer but to their social network as well. These restrictions in ADLs and physical functioning are daily reminders of their cancer. Transformations in one’s physical self, such as weight loss, changes in one’s voice, and coughing and wheezing, can result in changes in perception of body image. For many lung cancer patients, difficulties in adapting to these changes can be amplified by the stigma of lung cancer. Changes, from appearance to feelings and thoughts, can have unexpected consequences on body image and self-perception. As suggested by Fingeret and colleagues, “It would be ideal to discuss body image with every patient during each encounter but given the infeasibility of this goal, it is important to focus on patients whose disease or treatment causes significant self-perceived changes in physical appearance or function.”9 Living with lung cancer brings changes in self-perception not only through physical and

Christin Washington, Prep for Prep 9, Sophomore, Amherst College 2017

Dawn Zador, Senior Education Program Manager, CancerCare

Carolyn Messner, DSW, OSW-C, LCSW-R, Director of Education and Training, CancerCare

psychosocial alterations but also through the stigma associated with the disease. Low self-esteem may often lead to sadness, depression, social withdrawal, and distress. For the oncology nurse, understanding the impact lung cancer may have on patients’ body image and self-esteem is important in helping patients access needed psychosocial support programs and services. The psychological impact of lung cancer stigma In addition to lowered self-esteem and body image challenges, those living with lung cancer often face increased psychological challenges, especially if, as mentioned, the stigma of lung cancer has been internalized. Roughly 33% of lung cancer survivors have a negative view of themselves and may feel responsible for their diagnosis, which may lead to higher levels of guilt, shame, anxiety, and depression. Approximately 25% of all patients with lung cancer experience clinical depression at some point during their cancer trajectory.10 Oncology nurses are at the forefront of administering oncology care and support. They are often delivering bedside care at the point of diagnosis or during different phases of patients’ treatment. It is vital for oncology nurses to recognize these symptoms of sadness and depression in their patients and to understand that patients’ feelings of shame, guilt, and embarrassment are intertwined with their quality of life. Access to treatment for lung cancer patients People living with lung cancer and experiencing its stigma often do not report symptoms and delay seeking treatment and help. Reluctance to seek medical intervention has significant consequences. When medical help is sought early, there are significantly greater treatment options with potential for improved prognosis and survival outcomes. The incidence and death rates for lung cancer have been declining in part due to changes in “patterns of smoking uptake and cessation.”1 Subsets of patients with lung cancer are benefiting from the novel treatment approaches that have recently been developed.11 Decreasing delays in early detection may also improve survival.

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Lung Cancer

Impact on funding for lung cancer research The stigma of lung cancer not only impacts the well-being of patients but also influences federal and private funding. Lung cancer funding and research lag far behind those of other cancers in spite of its being the leading cause of cancer deaths. Many have attributed this disparity to the stigma of lung cancer, the â&#x20AC;&#x153;blame-the-victimâ&#x20AC;? attitude that results in limited funding for lung cancer research. This stigma has been acknowledged by medical professionals, advocacy groups, scholars, and the media. While there is recognition of the existence of stigma for lung cancer patients, research evaluating its impact is limited.2 Statistics show that the National Cancer Institute and the Department of Defense spend far less on lung cancer research compared with other cancers. More information is needed to assess the impact that stigma generates in order to eradicate its detrimental bias toward research funding for lung cancer.4

Oncology nurses can take the lead in providing patients and their loved ones with reliable and credible websites to obtain information. Less grant money is available for lung cancer patients compared with other types of cancer. The fact that more funding and resources exist for so many other types of cancers exacerbates the lack of resources available for patients with lung cancer.2 Oncology nurses and other members of the healthcare team need to become advocates to promote increased funding for lung cancer research and the development of resources for these patients and their caregivers.

Overcoming the Stigma

Educating the public One way of overcoming stigma is through increasing awareness and education. Education about the complex factors that may lead to a diagnosis of lung cancer, including environmental risks, genetics, and lifestyle, is needed to reduce the harmful psychological and physical effects of the associated stigma. Understanding the psychosocial sequelae that the stigma of lung cancer places on patients and their caregivers is an important step toward eliminating bias among healthcare professionals who are much needed to advocate for these patients and their caregivers. Gaining support of public figures and prestigious institutions The stigma of lung cancer is amplified by inadequate support from public figures and institutions. Though the lung cancer cause has been championed by such celebrities

february 2015 â&#x20AC;˘ Volume 6, number 1

as Dana Reeve and S. Epatha Merkerson, support has been on a smaller scale. In contrast, AIDS was extremely stigmatized until many Hollywood celebrities began speaking out. Breast cancer stigma was diminished when Betty Ford came forward with her diagnosis in 1974,4 followed years later by Nancy Reagan. In both cases, having multiple, vocal celebrity endorsements boosted the public profile of these diseases and encouraged support, greater awareness, and increased federal research spending. In addition, smoking is becoming much less common in the public sphere. Workplaces and restaurants in the United States and globally are increasingly becoming smoke-free environments due to advocacy groups. Elected officials, for example, former Mayor Michael Bloomberg of New York City, extended smoke-free environments to include public spaces, parks, and beaches. These are efforts to reduce exposure to secondhand smoke and discourage smoking. Advocacy for lung cancer faces a tougher battle. With higher mortality rates, few patients and their family members are able to stay the course as long-term lung cancer advocates. In addition to family members, oncology nurses, and other members of the healthcare team and their institutions must fill these gaps, and become strong lung cancer advocates, ensuring that patients receive high-quality and compassionate care. Using the Internet for health communication Patients with stigmatized illnesses such as lung cancer may avoid seeking medical attention or health education.12 Too often, lung cancer is diagnosed in its later stages. Information and education are imperative in receiving state-of-the-art medical care for people living with lung cancer. Understanding what symptoms to look for and what questions to ask, and maintaining open lines of communication with family, friends, and healthcare professionals contribute to timely treatment and decreased feelings of stigmatization. The Internet can be a useful tool for health education and outreach. A national survey conducted in 2005 compared people with a self-reported stigmatized condition with people having at least one other chronic illness. The survey found that the respondents with stigmatized illnesses were significantly more likely to use the Internet for health information research, to have communicated with clinicians about their condition through the Internet, and to have increased utilization of health information based on information found on the Internet. The results from this study suggest that the Internet is a valuable health communication and education tool for those who are affected by stigmatized illnesses.12 Oncology nurses can take the lead in providing patients and their loved ones with reliable and credible websites to obtain information.

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Lung Cancer

Support Programs/Resources

The stigma of lung cancer can have an adverse psychosocial impact on patients and their caregivers. One way to cope with lung cancer is to take advantage of support programs and resources. These support programs are provided by general cancer organizations, lung cancer–specific organizations, and hospital settings. See on this page a list of reliable and well-vetted websites that provide support and education for patients, their caregivers, friends, and healthcare professionals. The role of lung cancer support groups The organizations on this list provide important information about free support groups, counseling, educational programs, publications, financial assistance, and other services. The information and resources these organizations offer help connect people to a community of patients with lung cancer and healthcare professionals. Fostering communication within a community of lung cancer patients is another method of overcoming the stigma. Support groups provide psychosocial support for people living with lung cancer and are a wonderful way for people to share their experiences. Promoting an environment where people feel comfortable and safe communicating their worries helps to break the cycle of silence that people living with lung cancer experience. More lung cancer support groups are needed, as these resources are not widely available for patients. Often, pa-

Lung cancer–specific organizations:

• Free to Breathe – www.freetobreathe.org • Lung Cancer Alliance – www.lungcanceralliance.org • LungCancer.org – www.lungcancer.org • LUNGevity Foundation – www.lungevity.org

General cancer organizations: • American Cancer Society – www.cancer.org • American Society of Clinical Oncology – www. cancer.net • CancerCare – www.cancercare.org • Cancer Support Community – www. cancersupportcommunity.org • LIVESTRONG Foundation – www.livestrong.org • National Cancer Institute – www.cancer.gov • National Coalition for Cancer Survivorship (NCCS) – www.canceradvocacy.org • NeedyMeds – www.needymeds.org • Oncology Nursing Society – www.ons.org • The LGBT Cancer Project – www.lgbtcancer.org

february 2015 • Volume 6, number 1

tients with lung cancer attend support groups for other types of cancers. But these meetings may not be as effective, as cancer is specific to location of the disease.2 Despite the positive role of support groups, participation of patients with lung cancer in available groups remains low. According to a study done in 2010, low attendance may be due to disparities between patients and facilitators about support program logistics—including preferred location, type of facilitator, and content.13 For instance, the study found that patients with lung cancer preferred programs held in hospitals, whereas facilitators preferred groups in a community setting. Patients preferred facilitation by trained health professionals, whereas facilitators preferred volunteers. Patients preferred the focus of the group to be on providing cancer information rather than providing emotional support, whereas facilitators preferred the opposite. These differences may explain the poor attendance at existing support groups by lung cancer patients. Other factors that pose additional barriers to attending on-site support programs include the rigors of travel, the costs of travel, parking concerns, fatigue, family or partner obligations, and child care. To encourage participation, support groups need to be tailored to the needs of patients and their caregivers. Increasingly, groups are being offered as telephone support groups or online groups to facilitate participation and overcome the physical barriers and costs of travel to attend on-site groups. If groups are held at hospitals or in community settings, it is recommended that a brief needs assessment be conducted to determine the preferences of patients and caregivers for the site or location of the group, its frequency, as well as the focus of the group as psycho educational or support or both.

The Important Role of the Oncology Nurse

Oncology nurses provide important and enduring support for patients. Oncology nurses not only have greater interaction with the patient than any other member of the oncology team, they are often the patient’s first line of support. Oncology nurses are in a critical position to provide the necessary psychosocial support patients living with lung cancer need. Below are some tips and suggestions that oncology nurses can use in helping patients with lung cancer cope with their diagnosis. Nonjudgmental approach to lung cancer patients It is first and foremost essential for oncology nurses to debunk any bias they may have toward patients with lung cancer. It is important for oncology nurses to understand that stigma toward this population exists, but is unfounded: there are many mechanisms for developing lung cancer,

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lung cancer

Smoking cessation programs: American Cancer Society – 800-227-2345 National Cancer Institute, Free Help to Quit Smoking Smoking Quitline – 877-44U-Quit (877-448-7848) Smokefree.gov – www.smokefree.gov

State quit lines: Quit for Life – 866-784-8454 State Quit Line – 800-Quit-Now (800-784-8669) and smoking, for those individuals who smoke, is a highly addictive habit and difficult to quit. It is also important for nurses to recognize that the stigma associated with lung cancer may be hurtful for patients living with lung cancer. Smoking cessation programs Even after a diagnosis of lung cancer, it is possible to improve survival rates and quality of life by ending tobacco use. Smoking cessation programs play a key role in helping patients with lung cancer achieve these goals. According to one study, although there are many effective treatments available to help smokers quit, persistent efforts through repeated contacts are necessary to achieve long-term cessation. Oncology nurses interact with patients frequently enough to engage in these necessary “repeated contacts.”14 Due to their frequency of contact with patients, oncology nurses play an essential role in the identification of and intervention with patients struggling with tobacco dependence after their diagnosis. It is crucial for oncology nurses to take advantage of their unique position to try to help lung cancer patients stop smoking. There are many smoking cessation programs available to help lung cancer patients who wish to stop smoking; see the list on this page. Helping lung cancer patients cope Oncology nurses also play a key role in discussing quality of life with lung cancer patients. Nurses may focus on treatment and disease management, but it is important for oncology nurses to listen to patients’ concerns. In this way, nurses can help promote patients’ psychosocial adaptation to their diagnosis. Nurses’ supportive, nonjudgmental listening may lessen patients’ feelings of isolation. By empathic listening, oncology nurses may help patients with their worries. Oncology nurses can also help patients cope by providing educational materials, exploring life stories, discussing personal relationships, suggesting spiritual resources, and helping patients consider treatment and palliative care choices. These discussions afford vital psychological support for patients who have been newly diagnosed with or are living with lung cancer.15

february 2015 • Volume 6, number 1

Fostering communication In conclusion, it is imperative for oncology nurses to help patients with lung cancer overcome the stigma of this disease. As mentioned previously, patients with lung cancer often believe they caused their own cancers, leading to a negative self-image and psychosocial difficulties. It is therefore essential for oncology nurses to foster an environment of open communication among themselves and with patients and to discuss issues such as cancer causation as well as the patient’s feelings of guilt, shame, depression, and anxiety.16 Addressing the stigma of lung cancer is essential for those living with the disease. Through communication, education, and strategic campaigns, public opinion can be molded. Changes in public perception and the psychosocial burden placed on the individual begin in the hospital room with the oncology nurse. g

References

1. American Cancer Society. Cancer Facts & Figures 2014. Atlanta, GA: American Cancer Society; 2014. 2. Conlon A, Gilbert D, Aldredge P. Stacked stigma: oncology social workers’ perceptions of the lung cancer experience. J Psychosoc Oncol. 2010;28(1):98-115. 3. Else-Quest NM, LoConte NK, Schiller JH, et al. Perceived stigma, selfblame and adjustment among lung, breast and prostate cancer patients. Psychol Health. 2009;24(8):949-964. 4. Huber B. Stigma of ‘smoker’s disease’ stifles fight against No. 1 killer, lung cancer. FairWarning. www.fairwarning.org/2012/11/stigma-of-smokers-disease- stifles-fight-against-no-1-killer-lung-cancer/. Published November 1, 2012. Accessed December 29, 2014. 5. Thomas S. Huffman couple fights lung cancer stigma, pushes for awareness. Atascocita Observer. www.yourhoustonnews.com/atascocita/news/huffman- couple-fights-lung-cancer-stigma-pushes-for-awareness/article_3ebfbe2a-ea1355a0-a08d-b6e28330f494.html. Published November 3, 2012. Updated November 7, 2012. Accessed December 29, 2014. 6. Schiller J, Goodman A. The stigma of lung cancer: never-smokers: a growing trend. Medscape Oncology. www.medscape.com/viewarticle/807904_4. Published July 18, 2013. Accessed December 29, 2014. 7. Schiller J, Goodman A. Are lung cancer patients to blame for their disease? Medscape Oncology. www.medscape.com/viewarticle/807904_1. Published July 18, 2013. Accessed December 29, 2014. 8. Cessation. American Legacy Foundation. www.legacyforhealth.org/our- issues/cessation. Accessed December 29, 2014. 9. Fingeret MC, Teo I, Epner DE. Managing body image difficulties of adult patients: lessons from available research. Cancer. 2014;120(5):633-641. 10. Eldridge L. Lung cancer: the bias, the stigma, the shame, blame and guilt. www.lungcancerfoundation.org/2013/06/lung-cancer-the-bias-the-stigmathe-shame-blame-and-guilt/. Published June 24, 2013. Accessed December 29, 2014. 11. Cooley ME, Lynch J, Fox K, et al. Lung cancer. In: Holland JC, Breitbart WS, Jacobsen PB, et al, eds. Psycho-Oncology. New York, NY: Oxford University Press; 2010:chapter 20. 12. Berger M, Wagner TH, Baker LC. Internet use and stigmatized illness. Soc Sci Med. 2005;61(8):1821-1827. 13. Devitt B, Hatton A, Baravelli C, et al. What should a support program for people with lung cancer look like? Differing attitudes of patients and support group facilitators. J Thorac Oncol. 2010;5(8):1227-1232. 14. Cooley ME, Sipples RL, Murphy M, et al. Smoking cessation and lung cancer: oncology nurses can make a difference. Semin Oncol Nurs. 2008;24(1):16-26. 15. Vondrasek J, Cody J. Nurses Key in Helping New Cancer Patients Overcome Fears. Michigan State University Today. http://msutoday.msu.edu/ news/2012/nurses-key-in-helping-new-cancer-patients-overcome-fears/. Published February 28, 2012. Accessed December 29, 2014. 16. LoConte NK, Else-Quest NM, Eickhoff J, et al. Assessment of guilt and shame in patients with non-small-cell lung cancer compared with patients with breast and prostate cancer. Clin Lung Cancer. 2008;9(3):171-178.

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Lung Cancer screening

Effective Lung Cancer Screening Meg Barbor

“T

here’s a lot we don’t know about lung cancer screening,” according to Denise Aberle, MD, who spoke at the recent American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research. However, certain measures can be taken to lower false-positive and overdiagnosis rates, lessen costs, ameliorate patient suffering, and correctly identify screening cohorts, she asserted.

Who Should Be Screened?

The National Lung Screening Trial (NLST) recommends lung cancer screening for adults aged 55 to 74 years who have at least a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. The US Preventive Services Task Force (USPSTF) has the same screening criteria, but has made revisions based on the Cancer Intervention and Surveillance Modeling Network (CISNET) models that are funded by the National Cancer Institute; they have extended the screening period up to individuals aged 80 years and do not recommend screening for individuals who have not smoked within the past 15 years. The CISNET models that informed the USPSTF recommendations consist of 5 different consortiums, each having independent models for lung cancer, explained Aberle, vice chair of research and a professor in the Department of Radiological Science and professor of bioengineering at the University of California, Los Angeles. “When they looked across these 5 models they found a mortality reduction of anywhere from 8% to 24%. About half who went through screening had early-stage disease, and it is estimated that up to 500 per 100,000 lung cancer deaths across the population could be averted with the gain in life years,” she said. “Many others have recommended that we use risk prediction models to try to better hone in on those individuals who should be screened,” said Aberle. Their premise is that we determine a threshold below which individuals will not be screened, and that doing so will improve on the existing NLST criteria. However, “using these risk predictors practically can be somewhat problematic,” she added.

What Can Be Done About False-Positivity Rates?

The false-positivity rate was one of the major limitations of the NLST, said Aberle. Consequences of this in a screening setting include additional unnecessary imaging and radiation exposure, unnecessary biopsies and the complications of those biopsies, unnecessary anxiety, and additional cost, she explained.

february 2015 • Volume 6, number 1

According to Aberle, if we look only at the published data from the NLST and stratify the nodules that factored into positive screens over each of the screening intervals, we can see that nodules that were ≤6 mm amounted to more than half of positive screenings but were responsible for less than 1% of lung cancers overall; if we look at increasing nodule size, the positive predictive value goes up so that the larger the nodule, the more likely it is that the person has cancer. “This gives us a clue that size is important and might help us determine whether or not a screen is significant,” she suggested. “If we look at small nodules, 4-5 mm, we see that if we did nothing with those nodules but simply saw them one year later, we would suffer trivial effects with respect to the ability to diagnose lung cancer.”

When Is It Overdiagnosis?

“I understand the terms of overdiagnosis, and I understand the concept of overdiagnosis; I think where I stumble is when I look at the notion of overdiagnosis in the individual patient setting,” said Aberle. Questions concerning overdiagnosis are constantly raised, she noted. “But the only question for which there is a resounding answer is ‘we cannot assume a linear growth model.’” “Some of these cancers are going to get worse over time, even over long periods of time. Some of these cancers are going to stay just the way they were. Some of these lesions may actually regress,” she noted. “We just don’t know enough and I think it makes it challenging to make these kinds of decisions in the individual patient setting.”

Next Steps in Screening

Aberle stated that it will behoove society to measure risk in individuals who are screened, redefine actionable nodules to lower false positives, maintain low radiation doses using current multidetector scanners, track smoking cessation efforts and rates, and collect the data via screening centers. “Only in that way will we begin to understand what risk-to-benefit ratios are in the population setting and how we can maximize cost effectiveness,” she said. “There’s a lot we don’t know about lung cancer screening; I personally find that exciting because I want to be able to help answer some of those questions,” she added. g

Reference

Aberle DR. Lung cancer screening: from efficacy to effectiveness. Presented at: 13th Annual American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research; September 28- October 1, 2014; New Orleans, LA.

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3RD ANNUAL

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FIRST ISSUE IN A 5-PART SERIES THIRD ANNUAL

Conquering the Cancer Care Continuum Conquering Cancer Carthe i e Cont in SECoN

Good Manufacturing Practice Lillie D. Shockney, RN, BS, MAS

University Distinguished Service Associate Professor of Breast Cancer Johns Hopkins University School of Medicine, Baltimore, MD

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