February 2012, Vol 3, No 1

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© 2012 Green Hill Healthcare Communications, LLC NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARE TM FEBRUARY 2012 www.AONNonline.org VOL 3, NO 1 RECOGNITION Lillie Shockney Receives “Amazing Nurses” Award From Johnson & Johnson ORIGINAL RESEARCH Stress Therapy Empowering Prevention (STEP): A Healthy Lifestyle Program for Breast Cancer Patients ORIGINAL RESEARCH Patient Navigation: Blending Imaging and Oncology in Breast Cancer WEB SITE REVIEW Beyond the Shock: An Online Resource From the National Breast Cancer Foundation

description

The official journal of the Academy of Oncology Nurse Navigators, Inc.

Transcript of February 2012, Vol 3, No 1

Page 1: February 2012, Vol 3, No 1

© 2012 Green Hill Healthcare Communications, LLC

NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARETM

FEBRUARY 2012 www.AONNonline.org VOL 3, NO 1

RECOGNITIONLillie Shockney Receives “Amazing Nurses” Award From Johnson & Johnson

ORIGINAL RESEARCHStress Therapy EmpoweringPrevention (STEP): A HealthyLifestyle Program for Breast Cancer Patients

ORIGINAL RESEARCHPatient Navigation:Blending Imaging and Oncology in Breast Cancer

WEB SITE REVIEWBeyond the Shock: An OnlineResource From the National BreastCancer Foundation

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New Data: 5-Year Median Follow-up

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P

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In combination with MP* vs MP alone for previously untreated multiple myeloma

VELCADE DELIVERED 13-MONTH OVERALL SURVIVAL ADVANTAGE At 3-Year Median Follow-up, VELCADE® (bortezomib)+MP Provided an OS Advantage Over MP That Was Not Regained With Subsequent Therapies▼ Of the 69% of MP patients who received subsequent therapies,

50% received VELCADE or a VELCADE-containing regimen1

VELCADE is indicated for the treatment of patients with multiple myeloma.

VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

For Patient Assistance Information or Reimbursement Assistance, call 1-866-VELCADE (835-2233), Option 2, or visit VELCADE.com

*Melphalan+prednisone.† VISTA: a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE in combination with MP vs MP in previously untreated multiple myeloma. The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and OS. At a pre-specified interim analysis (median follow-up 16.3 months), VcMP‡ resulted in significantly superior results for TTP, PFS, OS, and ORR. Further enrollment was halted and patients receiving MP were offered VELCADE in addition.

‡VELCADE (Vc) in combination with MP.

Reference: 1. Mateos M-V, Richardson PG, Schlag R, et al. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010;28(13):2259-2266.

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MP (n=338)

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IMPORTANT SAFETY INFORMATIONVELCADE Warnings and Precautions ▼ Women should avoid becoming pregnant while being treated

with VELCADE. Pregnant women should be apprised of the potential harm to the fetus

▼ Peripheral neuropathy, including severe cases, may occur—manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment

▼ Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated

▼ Patients with risk factors for, or existing heart disease, should be closely monitored

▼ Acute diffuse infiltrative pulmonary disease has been reported

▼ Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement

▼ Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment

▼ Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and Acute Hepatic Failure have been reported

Adverse Reactions Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Other adverse reactions, including serious adverse reactions, have been reported

Please see Brief Summary for VELCADE on next page.

b

Median overall survival:

56.4 vs 43.1 months HR=0.695 (95% CI, 0.57-0.85); P<0.05

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TRIAL ANALYSIS (60.1-MONTH MEDIAN FOLLOW-UP)

HR=0.695 (95% CI,5

TRIAL ANALYSIS (60.1-MONTH MEDIAN FOLLOW-UP)

0.57-0.85); HR=0.695 (95% CI, m13.. 4 vs4 .65

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VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2011, Millennium Pharmaceuticals, Inc.All rights reserved. Printed in USA

Brief Summary

INDICATIONS:

VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS:

VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

WARNINGS AND PRECAUTIONS:

VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE.

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. Patients experiencing new or worsening peripheral neuropathy may require change in the dose and schedule of VELCADE. Following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with ≥Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. 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 13%. 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 Disorders: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported, 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, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the VELCADE and dexamethasone groups, respectively. The incidence of heart failure events (acute pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock, pulmonary edema) was similar in the VELCADE and dexamethasone groups, 5% and 4%, respectively. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.

Pulmonary Disorders: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) 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, a prompt comprehensive diagnostic evaluation should be conducted.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): There have been reports of RPLS in patients receiving VELCADE. RPLS 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 RPLS, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing RPLS is not known.

Gastrointestinal Adverse Events: 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.

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 remained consistent over the 8 cycles of twice weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study, the incidence of significant bleeding events (≥Grade 3) was similar on both the VELCADE (4%) and dexamethasone (5%) arms. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. The incidence of febrile neutropenia was <1%.

Tumor Lysis Syndrome: Because VELCADE is a cytotoxic agent and can rapidly kill malignant cells, the complications of tumor lysis syndrome may occur. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

Hepatic Events: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of VELCADE. There is limited re-challenge information in these patients.

Hepatic Impairment: VELCADE is metabolized by liver enzymes. VELCADE exposure is increased in patients with moderate or severe hepatic impairment. These patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities.

Use in Pregnancy: Pregnancy Category D. Women of childbearing 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 EVENT DATA:

Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the phase 3, VELCADE plus DOXIL® [doxorubicin HCI liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the phase 3 VELCADE + melphalan and prednisone study, the safety profile of VELCADE in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).

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. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. 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 melphalan-prednisone 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 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, the drug 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 VELCADE 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.

Please see full Prescribing Information for VELCADE at VELCADE.com.

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Journal of Oncology Navigation & Survivorship, ISSN appliedfor; (online) is published 6 times a year by Green HillHealthcare Communications, LLC, 241 Forsgate Drive,Suite 205C, Monroe Twp, NJ 08831. Telephone:732.656.7935. Fax: 732.656.7938. Copy right ©2012 byGreen Hill Health care Com muni cations, LLC. All rightsreserved. Journal of Oncology Navigation & Survivorship logois a registered trademark of Green Hill HealthcareCommunications, LLC. No part of this publication maybe reproduced or transmitted in any form or by any meansnow or hereafter known, electronic or mechanical, includ-ing photocopy, recording, or any informational storageand retrieval system, without written permission from thepublisher. Printed in the United States of America.

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ABOUT THE COVERAwakeningOil by a Person Diagnosed With Cancer Pennsylvania

Artwork from the Lilly Oncology On Canvas: Expressions of a CancerJourney Art Competition (www.LillyOncologyOnCanvas.com).

FEBRUARY 2012 • VOL 3, NO 1TABLE OF CONTENTS

RECOGNITION

7 Lillie Shockney Receives “Amazing Nurses” AwardFrom Johnson & Johnson

ORIGINAL RESEARCH

8 Stress Therapy Empowering Prevention (STEP): A Healthy Lifestyle Program for Breast Cancer PatientsBy Amy M. Burke, RN, BSN; Darrell L. Ellsworth, PhD;

Col (Ret) Marina N. Vernalis, DO, FACC

16 Patient Navigation: Blending Imaging and Oncology in Breast Cancer By Jeannine Arias, RN, MBA, MSN, CBCN, CBPN-IC

WEB SITE REVIEW

22 Beyond the Shock: An Online Resource From theNational Breast Cancer Foundation By Lillie D. Shockney, RN, BS, MAS

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6 FEBRUARY 2012 • VOLUME 3, ISSUE 1 AONNONLINE.ORG

Editor-in-ChiefLillie D. Shockney, RN, BS, MASUniversity Distinguished Service AssociateProfessor of Breast CancerDepts of Surgery and OncologyAdministrative Director, Johns HopkinsBreast Clinical ProgramsAdministrative Director, Johns HopkinsCancer Survivorship ProgramsAssociate Professor, JHU School ofMedicine, Depts of Surgery &Gynecology and ObstetricsAssociate Professor, JHU School of [email protected]

Section EditorsBreast CancerSharon Gentry, RN, MSN, AOCN, CBCNBreast Health NavigatorDerrick L. Davis Forsyth Regional Cancer Center

Prostate CancerFrank delaRama, RN, MS, AOCNSClinical Nurse SpecialistOncology/GenomicsCancer Care ClinicPalo Alto Medical Foundation

Healthcare Disparities Linda Fleisher, PhD, MPHAssistant Vice PresidentOffice of Health Communications & Health DisparitiesAssistant ProfessorCancer Prevention & ControlFox Chase Cancer Center

Health Promotion and OutreachIyaad Majed Hasan, MSN, FNPDirector and Nurse PractitionerSurvivorship Clinic and ProgramCleveland ClinicTaussig Cancer Center

AONN Research CommitteeMarcy Poletti, RN, MSN Program Administrator, Oncology ServicesWake Forest University Baptist Medical Center

Elaine Sein, RN, BSN, OCN, CBCNSenior Project ManagerFox Chase Cancer Center Partners

Penny Widmaier, RN, MSNNurse NavigatorBotsford Cancer Center

Executive Director, AONNSean T. [email protected]

MISSION STATEMENTThe Journal of Oncology Navi gation &Survivorship (JONS) promotes reliance on evi-dence-based practices in navigating patients withcancer and their caregivers through diagnosis,treatment, and survivorship. JONS also seeks tostrengthen the role of nurse and patient navigatorsin cancer care by serving as a platform for theseprofessionals to disseminate original research find-

ings, exchange best practices,and find support for their grow-ing community.

Dear Colleague,

I t is with great excitement that I intro-duce the first issue for 2012 of the Journalof Oncology Navigation & Survivorship.

I’m proud of what we accomplished in 2011– there has been some outstanding researchhighlighted on these pages in the past year,and I’m quite sure that this year will bringan even greater array of resources to assist both healthcare providers and patients,who are at the heart of it all.

This month’s issue features original research that focuses on 2 areas of improvingpatient care:

• Helping patients contribute positively to the outcome of their own disease bymitigating risk factors

• Retaining patients within a healthcare setting/system to better aid in continu-ity of care

Keep in mind that this journal is for you and about you and should reflect the cur-rent state of the specialty as it evolves. With that in mind, please continue to reachout with ideas, suggestions, and contributions for content since you know best whatresources there are to be shared with your peers and where there are knowledge gapsthat we can help to fill. Please pass this publication along to your colleagues as well.Since we believe that JONS offers valuable content for a whole host of healthcareprofessionals, we would love their input on issues and areas of interest to help can-cer patients navigate through their journey. g

With best regards,

Lillie D. Shockney, RN, BS, MASEditor-in-Chief

NAVIGATING OUR WAYTO THE FUTURE

“Keep in mind that thisjournal is for you andabout you.”

LETTERS FROM LILLIE

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RECOGNITION

LILLIE SHOCKNEY RECEIVES“AMAZING NURSES” AWARDFROM JOHNSON & JOHNSON

P eople within the Johns Hopkins community havelong known that Lillie Shockney is an amazingnurse. Now she’s got the moniker to prove it.

Shockney, administrative director of the JohnsHopkins Avon Foundation Breast Center since 1997,was selected as 2011’s “Amazing Nurse” in a nationalcontest to celebrate and reward nurses’ value, spon-sored by the Johnson & Johnson Campaign forNursing’s Future. Shockney’s work with breast cancerpatients was recognized by Johnson & Johnson duringthe 2011 CNN Heroes: An All-Star Tribute show inLos Angeles on December 11, 2011.Shockney, a two-time breast cancer survivor and reg-

istered nurse who has been employed by Johns Hopkinssince 1983, has worked tirelessly to improve the care ofbreast cancer patients around the world. She is respon-sible for the quality-of-care programs; patient educationprograms; the survivor volunteer team; community out-reach at a local, regional, and national level; the BreastCenter’s Web site, and patient advocacy. She also is cer-tified as a breast cancer oncology nurse and a breastcancer patient navigator. In 2008, the Johns HopkinsBoard of Trustees appointed her as the UniversityDistinguished Service Assistant Professor of BreastCancer – the first time in the history of the institutionthat a hospital nurse had received a distinguished serv-ice designation. She was promoted to associate profes-sor in 2010.“I am so excited about this,” Shockney said. “The

title really made me feel good. I hope one of the out-comes is that more people making a career decision willconsider nursing.”Shockney also has a joint appointment at the Johns

Hopkins University School of Nursing, where sheserves as a guest lecturer and distinguished speaker.Marie Nolan, PhD, MPH, RN, professor and chair ofthe Department of Acute and Chronic Care at theHopkins’ School of Nursing, who has known Shockneyfor 25 years and nominated her for the award, said thatas soon as she saw the title, she thought of Shockney,who has exhibited exceptional leadership skillsthroughout her career.

“She is a phenomenon, an unstoppable force, aliving example of how good can come from suffer-ing and how much good can be accomplished,”Nolan wrote in her nomination letter. “Like awhirlwind, she has changed breast cancer treatmentand survival at Johns Hopkins, in the U.S. andglobally.”“If you do a Google search on Lillie Shockney

you will literally find tens of thousands of hits,”Nolan says. “Her impact is remarkable.”Shockney initially was selected as one of 20 semi-

finalists from several thousand nominees. Johnson& Johnson asked voters to pick their favorite nom-inee on their contest’s Facebook page. “It becamethe cause célèbre at the School of Nursing,” Nolansays. “We were really behind her nomination andwe wanted her to win.”Shockney made the next cut, to 5 finalists, from

which she was selected as the top winner by a panelof 5 national nursing experts.Shockney holds a bachelor’s of science degree in

healthcare administration from Saint Joseph’sCollege and a master’s in administrative sciencefrom Johns Hopkins University.A published author and nationally recognized

public speaker on the subject of breast cancer, shehas written 13 books and more than 200 articles.She serves on the medical advisory board of severalnational breast cancer organizations and is the co-founder and vice president of a national nonprofitorganization called Mothers Supporting Daughterswith Breast Cancer.Shockney also is editor-in-chief of our peer-

reviewed journal, Journal of Oncology Navigation &Survivorship. She has commented on breast cancertopics for national television networks, print, andInternet media. The 2011 “Amazing Nurses” awardis Shockney’s 40th award. She has received awardsfrom the American Cancer Society, LanceArmstrong Foundation, Intel, Oncology NursingSociety, Susan G. Komen for the Cure Foundation,and other organizations. g

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ORIGINAL RESEARCH

8 FEBRUARY 2012 • VOLUME 3, ISSUE 1 AONNONLINE.ORG

E xtensive reports have documented the rela-tionship between lifestyle changes and mor-bidity/mortality associated with cardiovascu-

lar disease (CVD). In particular, diet, physicalactivity, and stress are known to be associated withcardiovascular morbidity and mortality.1-3 Similarto CVD, evidence has been mounting that breastcancer susceptibility is influenced in part by modi-fiable risk factors, such as body weight, diet, andphysical activity, suggesting that a healthy lifestyleprogram may lead to a reduction in risk factors forCVD and breast cancer. Improving health andquality of life in patients with CVD and breast can-cer will result in improved outcomes of care overthe long term. Early diagnosis and treatment are still vital to

surviving breast cancer. Although an estimated192,370 new cases of invasive breast cancer wereexpected in 2009, with approximately 40,170deaths from the disease, incidence rates actuallydecreased by 2.0% per year,4 likely due to

advanced screening and early detection. In aneffort to continue to lower incidence rates andimprove long-term outcomes, studies of behaviormodification in breast cancer patients are provid-ing new information about how lifestyle factorsaffect survivorship as well as knowledge to helpdevelop new, effective intervention programs todecrease breast cancer risk.5-11The Stress Therapy Empowering Prevention

(STEP) program is an innovative approach basedon the concept that comprehensive lifestylechanges may have a meaningful impact on therisk for developing breast and cardiac disease.Given the advantages of a healthy lifestyle onboth physical and emotional outcomes, cancerpatients as well as those at high risk should beurged to address unhealthy behaviors. Our STEPmodel utilizes a specialized team comprisingphysicians, nurses, dietitians, licensed therapists,exercise physiologists, and stress managementspecialists who provide comprehensive strategies

Stress Therapy Empowering Prevention (STEP): A Healthy Lifestyle Program for Breast Cancer PatientsBy Amy M. Burke, RN, BSNJoyce Murtha Breast Care Center at Windber Medical Center, Windber, PA

Darrell L. Ellsworth, PhDWindber Research Institute, Windber, PA

Col (Ret) Marina N. Vernalis, DO, FACC Walter Reed National Military Medical CenterIntegrative Cardiac Health Project (ICHP), Bethesda, MD

Purpose: Develop and implement a comprehensive program for lifestyle change, empowering breast can-cer patients to manage stress effectively and improve their mental and physical health. Method: Women with breast disease (or those at high risk) are offered a program of lifestyle change, con-sisting of a healthy lifestyle intervention for 3 months followed by monthly contact with a health coach.Instruction and demonstration provide information on exercise, nutrition, stress reduction, and mind/bodyhealth. Examinations are conducted at baseline, after completion of the intervention (3 months), at 1 year,and every 6 months for a period of 5 years. Conclusion: Breast cancer has a significant emotional, psychological, and social impact and is often asso-ciated with high levels of stress that promote unhealthy behaviors causing weight gain, decreased physicalfitness, and an increased risk for cardiovascular disease (CVD). Similar to CVD, research shows breast can-cer susceptibility is also influenced in part by modifiable risk factors, suggesting that a healthy lifestyle pro-gram may lead to reductions in cancer risk and recurrence as well as improvements in mental health andquality of life. Through the Stress Therapy Empowering Prevention (STEP) program, breast cancer and high-risk patients are empowered with tools to focus on health promotion and optimization and maintenance ofquality of life. Patients can improve physical and psychosocial factors in as little as 3 months, but long-termfollow-up will determine if lifestyle changes result in improved clinical outcomes over time.

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that empower the participant to make healthierchoices at an individual level. The program is anadjunct to treatment and care that participantsreceive from their personal healthcare providers.This combined effort allows for closer monitoringof each participant and coordination of careacross the healthcare spectrum to achieve opti-mal health and quality of life.

METHODSThe overall goal is to recruit and evaluate approx-imately 500 women diagnosed with, or at highrisk for, both breast and cardiac disease. Theobjectives of the study are to (1) test the efficacyof a healthy lifestyle intervention on reducingstress, sleep disturbances, and cardiovascular riskfactors in both high-risk patients and patientsdiagnosed with breast disease; (2) evaluate thelong-term benefit of an enhanced health coachintervention in promoting sustained wellnessbehaviors; and (3) examine molecular markerscommon to atherosclerosis and cancer to assesslongitudinal changes and their relationship to dis-ease development.

The STEP program has a 3-month healthylifestyle intervention period during which partic-ipants meet once a week to learn the programguidelines, which include a low-fat, whole foodnutrition plan based on the Mediterranean diet,aerobic and strength training exercises, stressmanagement, and weekly mind/body health ses-sions. After the initial 3-month period, partici-pants are contacted on a monthly basis by ahealth coach to ensure that program complianceis being maintained and to assist with long-termadherence. Participants are required to return tothe center at the 1-year time point, and every 6months thereafter for a period of 5 years, for test-ing and evaluation. Information collectedincludes perceived stress, sleep disturbance, psy-chosocial measurements, carotid ultrasound tomeasure carotid intima-media thickness, tradi-tional risk factors (weight, blood pressure, bodymass index [BMI], body composition), and bio-chemical assays.

To be eligible to participate, women must be 18years of age or older with a diagnosis of breast dis-ease (atypical hyperplasia, in situ carcinoma, orinvasive breast cancer) or significant risk factorsfor developing breast disease such as previousbiopsy, family history of breast disease, first preg-nancy after the age of 30, early menstruation or

late onset of menopause, or high risk of develop-ing coronary artery disease (CAD) as indicated byhaving 1 or more of the following: family historyof CAD, hypertension, diabetes, smoking, elevat-ed blood lipids, sedentary lifestyle and obesity, orestablished clinically stable coronary disease.

Participants begin the program with an exten-sive physician visit to conduct a comprehensiverisk assessment and develop a realistic lifestylechange plan. Participants are interviewed to assesssleep patterns, smoking status, cardiovascular andbreast history, and medication use. The clinicalexam includes height and weight measurements tocalculate BMI (kg/m2); blood profiles includingthyroid-stimulating hormone, comprehensivemetabolic panel, and fasting glucose and lipidpanel; systolic and diastolic blood pressures; andpsychological screening to evaluate mental health.Assessments are repeated at the end of the healthylifestyle intervention, at year 1, and every 6months thereafter for a period of 5 years.

Following the initial examinations, partici-pants attend an educational workshop designedto provide further instruction regarding the rec-ommended lifestyle changes, followed by once-a-week sessions over a 3-month period. These ses-sions are tailored to ensure that each individualreceives the appropriate education and experi-ence needed to achieve success. Participants arerequired to complete a personal awareness logeach week, which includes documentation ofdiet, exercise, and stress management frequencyand duration, and a self-report of their mind/bodysession experience.

Blood samples are obtained from each consent-ing individual at baseline, at completion of thehealthy lifestyle intervention, at 1 year, and every6 months thereafter for a period of 5 years. Fromthe blood samples, the following biochemicalassays are analyzed: (1) lipoprotein subclass distri-butions determined by nuclear magnetic reso-nance (NMR) spectroscopy; (2) stress/CVD bio-marker panel: serum cortisol, insulin, leptin,high-sensitivity C-reactive protein, lipo -protein(a), adiponectin, resistin, serum amyloidA, and vitamin D; and (3) breast disease–relatedpanel: HER2/neu, tumor necrosis factor (TNF)alpha, and estradiol. In addition, blood is collect-ed for isolating messenger RNA to determinechanges in gene expression over the course of thestudy and identify new molecular markers associ-ated with improved CVD biomarker risk profiles.

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RESULTSRecruitment is being conducted primarilythrough newspaper and radio ads; distribution ofpatient information brochures; and speakingengagements at various community educationevents, physician offices, and support groups. Of 43women who initially expressed interest in the pro-gram, 18 have enrolled thus far. Average age of participants was 65 years. Of the 18 participantsenrolled in the program, 11 women had diagnosedbreast disease (61%). In addition, of these same 18women, 17 (94%) were also considered at high riskfor developing CVD by having at least 1 docu-mented CAD risk factor. Overall attendance was88% during the initial 3-month on-site sessions.Four participants (22%) discontinued participa-tion in the program, 3 due to personal, nonmedicalreasons, and 1 due to breast cancer progression. Upon completion of the healthy lifestyle inter-

vention (3 months), participants (n = 14) showedchange in the desired direction for many risk fac-tors. Body weight (-1.8%, P <.05), BMI (-2.5%, P <.05), and perceived stress (-22.1%, P <.05)decreased significantly. Diastolic blood pressure (-8.4%, P <.08) and sleep quality (-26.5%, P <.06) showed near-significant changes. Mostimportantly, at the 1-year time point, perceivedstress (n = 10, 8.2%, P <.05) and sleep quality (n = 9, -4.9%, P <.05) improvements were main-tained, showing that these positive changes couldbe maintained over a longer period of time. Inaddition, though lacking statistical significancewith our current sample size, triglycerides, systolicblood pressure, hostility, and depression alldecreased at both time points (Table).Based on self-reported exercise frequency and

duration data, at 3 months participants on averagewere able to increase vigorous activity (heavy lift-ing, digging, aerobics, or fast bicycling) by 1.13days/week, moderate activity requiring the partici-pant to breathe somewhat harder than normal(carrying light loads or bicycling at a regular pace)by 1.56 days/week, and walking activity (includingwalking at work or home for recreation, sport,exercise, or leisure) by 1.63 days/week. At the 1-year time point, participants continued to showincreased levels of activity for all measured cate-gories; vigorous activity remained increased by1.13 days/week, moderate activity by 1.13 days,and walking activity by 0.82 days when comparedwith baseline activity. Lipoprotein subclass profiles will be assessed by

NMR spectroscopy, which will quantify low-densi-ty lipoprotein particle number and size, and pro-vide direct measurement of high-density lipopro-tein and very low-density lipoprotein subclasses.Biochemical variables of interest regarding CVDrisk, including insulin, leptin, lipoprotein(a),adiponectin, resistin, serum amyloid A, and TNFalpha will permit correlation of traditional CVDrisk factors with nontraditional biomarkers to pro-vide more information on the prevention andtreatment of CVD. Vitamin D, HER2-neu, andestradiol will be analyzed to provide further insightinto breast disease development and progression.Lower serum 25 (OH) D (vitamin D) concentra-tions may be associated with poorer overall sur-vival and distant disease-free survival in post-menopausal breast cancer patients.12 HER2-neublood levels have potential as a tumor marker inbreast cancer. Many studies have monitored circu-lating levels after surgery and reported that increas-ing HER2-neu levels can indicate recurrence ofbreast cancer earlier than clinical diagnosis.13,14Estrogens are believed to play a critical role in theetiology of breast cancer, and considerable evi-dence suggests that lifetime exposure to endoge-nous hormones, notably estrogens, promotes breastcarcinogenesis.15 Finally, cortisol levels, considereda major indicator of altered psychological states inresponse to stress, may provide information onshort- and long-term stressors.16

DISCUSSIONThere are no proven substitutes for conventionalcancer treatments such as surgery, chemotherapy,radiation, and immunotherapy; however, oneapproach to gaining a better understanding ofhow lifestyle change can enhance breast cancersurvival is to develop studies that address severalbehavior and lifestyle factors within the same pro-gram. Research has shown that among womenwith breast cancer who had surgery and conven-tional treatment, those who learned to changetheir lifestyle through education focused on betternutrition, more exercise, and stress reductionwere 68% less likely to die from disease over an11-year period than those who did not.17Although the STEP study currently lacks long-term follow-up data, our program is examiningthe importance of helping breast cancer patientseat better, lose weight, improve strength andendurance, develop coping skills, and ultimatelyto improve their overall health and well-being.

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Participants in a STEP-style program feel better,both physically and emotionally. These observa-tions suggest that the program has potential toimprove their long-term overall risk profiles. An important finding in our study was the

struggle encountered in recruiting participantsinto the program. Obstacles to recruitmentincluded out-of-pocket expenses, lack of localphysician referrals, participant time constraints,and lack of knowledge among patients about thebenefits of lifestyle change on quality of life orclinical outcomes. However, once women madethe commitment to participate, surveys indicateda high degree of satisfaction with the program.Ultimately, issues encountered with recruitmentaffected our sample size, leading to difficulties inbeing able to effectively interpret preliminarydata. In the future, we will continue to use bestclinical judgment on when to approach appropri-ate patients based on past experience, to repeat-edly offer to assist patients with addressing riskfactors, and to educate healthcare providers aboutthe STEP program to increase our sample size andprovide additional data for analysis of the effectsof lifestyle change on breast disease.

NUTRITIONAlthough the relationship between diet andbreast cancer remains unclear, studies haveshown that improved nutrition reduces the riskof several chronic diseases, such as obesity, dia-betes, and heart disease, and that a healthylifestyle improves overall quality of life.18,19

Breast cancer patients who practice better nutri-tion are likely to derive benefit in terms of totalmortality, similar to the general population. TheWomen’s Healthy Eating and Living studyshowed that women who consumed a healthydiet and were physically active increased sur-vival after diagnosis.20 Patients who reportedeating at least 5 servings of fruits and vegetablesper day and performing 30 minutes of moderatewalking 6 days a week reduced the probability ofdeath by 50%. The STEP program nutrition plan is based on

the Mediterranean diet and recommends eatingvegetables; fruits; whole grains; lean proteinsources such as fish and nuts; and olive oil; andminimizing the amount of red meat consumed.Participants are counseled to focus on eatingmore naturally occurring and fewer highlyprocessed foods. Involvement of a registered die-titian helps to guide this process and provides theeducation, support, and long-term follow-upneeded to meet the challenges of sustaining therecommended dietary changes. The majority of studies of diet and breast can-

cer have examined the impact of body weight onsurvival. Most have observed that obesity at diag-nosis is associated with poor prognosis.21 Similarly,weight gain after diagnosis is common and is asso-ciated with mortality, disease recurrence, anddevelopment of comorbid conditions includingdiabetes and CVD.22 Although some studies haveshown that following a prudent diet alone, with-out adding physical activity, may not be associat-

Table Change in Selected Physical and Psychosocial Variables

Outcome Baseline 3 Months %Δ P a 1 Year %Δ P a

Weight 180.5 177.3 -1.8 <.05 175.6 -2.7 .10

Body mass index 32.5 31.7 -2.5 <.05 31.5 -3.1 .38

Total cholesterol 201.1 200.2 -0.5 .90 203.4 +1.1 .73

Triglycerides 157.2 136.7 -13.0 .17 147.6 -6.1 .52

Systolic blood pressure 134.0 125.1 -6.6 .15 126.4 -5.7 .23

Diastolic blood pressure 79.6 72.9 -8.4 .08 76.3 -1.3 .28

Glycosylated hemoglobin 6.4 6.6 +3.1 .34 6.2 -3.1 .30

Fasting glucose 108.6 110.6 +1.8 .75 112.4 +3.5 .51

Depression 13.7 11.3 -17.5 .23 8.5 -38.0 .11

Hostility 6.4 4.8 -25.0 .16 5.7 -10.9 .33

Perceived stress 16.3 12.7 -22.1 <.05 11.7 -28.2 <.05

Pittsburgh sleep quality index 10.2 7.5 -26.5 .06 9.7 -4.9 <.05aP value based on repeated-measures analysis of variance.

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ed with breast cancer survival,5,23 a healthy diethas been shown to have beneficial effects onoverall survival in conditions such as diabetes andheart disease, which are frequently seen in breastcancer patients.24

Participants in the STEP program were able tosignificantly decrease measures of obesity such asweight and BMI within the first 3 months of theprogram. Although these measures were not sta-tistically significant at 1 year, they continue toremain lower than at baseline, suggesting thatparticipants were successful in meeting or exceed-ing dietary compliance targets, thus preventingweight gain and promoting weight loss, which hasbeen proven to be an effective strategy forimproving overall quality of life and survival.

EXERCISEPhysical activity is as important as diet for achiev-ing optimal weight and maintaining a healthylifestyle. In studies examining the relationshipbetween physical activity and the risk of breastcancer, a decrease in risk of approximately 25%was found among the most physically activewomen.25 Similarly, in studies examining theeffect of physical activity on breast cancer sur-vival, some studies suggest that postdiagnosisphysical activity may have great benefit. Onestudy showed that after diagnosis, physical activi-ty equivalent to walking 3 to 5 hours per weekreduced mortality by as much as 50%.26 Althoughthe risk of developing comorbid conditions,including CVD, type 2 diabetes, fatigue, lymph -edema, psychological distress, and poor quality of life, often persists in breast cancer survivors,recent studies have shown that physical activitycan lower breast cancer risk and provide addition-al health benefits, such as decreased risk of strokeand type 2 diabetes, and improved longevity andquality of life.27

Most STEP participants achieved improve-ment in physical activity during the initial 3-month period, and many maintained these initialgains or continued to improve by the end of thefirst year. While most research demonstrates ben-eficial effects between physical activity and over-all health, it is important to recognize that thereis a risk-benefit ratio to exercise that may be dif-ferent for each breast cancer patient. Utilizing apersonalized plan might be most effective becauseit can be customized for different time periods,from prediagnosis through cancer treatment,

based on individual needs and abilities. TheSTEP program develops each participant’s activi-ty plan based on an individual assessment com-pleted by an exercise physiologist, but generallyparticipants are encouraged to exercise aerobical-ly for a minimum of 30 minutes per day, for a totalof 3 hours of aerobic exercise each week. Moreintense exercise is permitted if medically appro-priate and desired by the participant. Resistive orstrength training exercise also is important, and ifmedically appropriate, participants were instruct-ed to engage in strength training exercises 2 to 3times per week. During the healthy lifestyle inter-vention portion of the study, hour-long supervisedexercise sessions were scheduled.

The objectives of our exercise modality are tofully understand the importance and benefits ofregular physical activity, to create a safe environ-ment for exercise, and to encourage participants toproperly monitor their own exercise program out-side of the STEP program. These activities willassist with long-term adherence and allow the par-ticipant to achieve her own physical activity goals.

STRESS MANAGEMENTWorking with participants in the STEP programpresents some unique challenges. These womenhave faced their mortality and live with the ongo-ing psychological stress of possible cancer recur-rence.28 A recent meta-analysis of 10 randomizedcontrolled trials found that cancer patients whoparticipated in yoga interventions showed signifi-cant improvement in several psychological meas-ures, including anxiety, distress, depression, andstress compared with wait-list controls.29 Forbreast cancer survivors in particular, yoga hasbeen shown to improve quality of life and emo-tional functioning.30

A mild form of physical activity, such as yogaor tai chi, may help to promote regular partici-pation in physical activity. The therapeuticapplication of yoga enables participants tomove slowly and safely, concentrating on relax-ing their body while building flexibility,strength, and balance, which is especiallyimportant in breast cancer patients who mayface additional barriers to more vigorous physi-cal activity.31 As emotional stress has beenassociated with decreased survival in breastcancer patients,32 possibly by muting immunefunctions and accelerating the inflammatoryresponse, stress management may offer a real

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survival advantage to cancer patients in addi-tion to emotional benefits.

The STEP program’s stress management spe-cialist is a certified yoga therapist trained in tech-niques to provide participants with healthier waysto deal with the stress of living with a potentiallylife-threatening disease. The practice of yogarelies on physical postures to stretch muscles,focused breathing and meditation to minimizestress through visualization techniques, and guid-ed imagery. Throughout the initial intervention,stress management sessions are held once a week.During these sessions, participants receive educa-tion and training in performing these techniques.The result is a relaxed body and a peaceful state ofmind. Daily stress management practice wasencouraged in the STEP program so that thesetechniques would be routine when patients arefaced with a stressful situation.

MIND/BODY HEALTHWomen with breast cancer often exhibit emo-tional distress similar to posttraumatic stress dis-order (PTSD).33,34 In a recent study, amongwomen who were recruited an average of 47months following diagnosis of breast cancer, 38%had moderate to high anxiety, 22% had moderateto high depression, and PTSD was observed in12%.35 These findings show that the emotionalimpact of breast cancer can last for years follow-ing diagnosis. In addition, women lacking a socialnetwork had a significantly higher risk of breastcancer mortality than women with strong socialties to relatives, friends, and neighbors. Breastcancer patients often experience social isola-tion due to treatment, body image issues, orfatigue, which can have significant detrimentaleffects on psychological well-being by increas-ing levels of anxiety and depression. Therefore,it is important to recognize the signs of psycho-logical distress in breast cancer patients anddevelop programs that effectively manage stressand mental health.36

The mind/body sessions in the STEP programare facilitated by a licensed therapist. These ses-sions are designed to create an atmosphere inwhich participants feel comfortable expressingtheir feelings and personal experiences. Since allSTEP participants share common ground, indi-viduals who self-disclose their experiences indealing with breast disease encourage other par-ticipants to share their experiences as well. The

overall purpose of the mind/body session is tocreate an environment where participants canexperience belonging and the feeling of beingconnected. It is important to understand thatthese sessions are not group therapy – they areintended to facilitate making and sustaininghealthy behaviors every day. Most of us knowwhat we need to do to lead healthier lifestyles,but change is difficult to attain and sustain with-out ongoing support. This component upholdsaccountability, and the participants come todepend on each other for ongoing support.

CONCLUSIONIn summary, lifestyle change interventions haveproven to be beneficial to the vast majority ofparticipants, but there are a limited number ofstudies that have examined the effect of combin-ing several lifestyle behaviors into one compre-hensive program to benefit breast cancer patients.The STEP program is a pioneer program that hascombined the efforts of conventional treatmentregimens with simple lifestyle changes, empower-ing breast cancer patients to actively managetheir disease. As well-powered randomized con-trolled trials continue to define the effectivenessof lifestyle modification, hopefully more compre-hensive programs will become available andeventually translate into improved care for breastcancer patients. g

AcknowledgmentsThe STEP program at Windber Medical Center is ajoint effort of many investigators and staff memberswhose contributions are gratefully acknowledged. Weespecially thank the program participants. This programis supported by the US Department of Defense throughthe Henry M. Jackson Foundation for theAdvancement of Military Medicine Initiative (MilitaryMolecular Medicine Initiative MDA W81XWH-05-2-0075). The opinions and assertions expressed hereinare the private views of the authors and are not to be

“The mind/body sessions...are designed to create an atmosphere inwhich participants feel comfortable expressing their feelings and personal experiences.”

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construed as reflecting the views of the Departmentof the Army or the Department of Defense.

DisclosuresAmy M. Burke, RN, BSN, has nothing to disclose.Darrell L. Ellsworth, PhD, has nothing to disclose. Col(Ret) Marina N. Vernalis, DO, FACC, receivesfunding through the Henry Jackson Foundation for herwork on the Integrative Cardiac Health Project atWalter Reed National Military Medical Center.

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P atient navigation in cancer care refers to theindividualized care provided to breast cancerpatients, families, and caregivers to ease

multiple barriers and facilitate timely access toqualified medical and psychosocial care.1 The rel-atively new patient navigation concept hasbecome a healthcare buzzword as organizationsstrive to increase program efficiencies and systemretention rates.2 Professionals linked to hospitalsand community outreach efforts seek to improvethe patient’s breast care experience with innova-tive strategies to attract and retain patients. Theregional patient navigation focus has been tocarve out personalized care service and exceedpatient expectations.3 The term patient navigation is now used inter-

changeably for many layers of patient services.Patient navigator, however, has 2 well-accepteddefinitions: (1) an individual who may periodi-

cally assist with the coordination of care; (2) anindividual who is educated to provide continuoussupport to patients along the entire illness trajec-tory.2 Our regional breast centers are consideredhigh-volume, low-acuity tumor sites. Main tainingconsistently stable volumes has justified the pres-ence of a full-time navigator.3 The inception of ournavigation program came as the result of out-migration of breast biopsy patients and began withradiology technologist navigators intervening atthe diagnostic evaluation process in breast imag-ing. For the purpose of this study, our region iden-tifies with the second definition, and the duties ofthe patient navigator include patient needs assess-ment, patient education, therapeutic support, andcoordination of care along the illness trajectory.2 Avast amount of literature supports the profession ofnursing to assume the role of the patient navigator.Fifty-five percent of navigators currently working

Patient Navigation: Blending Imaging and Oncology in Breast CancerBy Jeannine Arias, RN, MBA, MSN, CBCN, CBPN-ICAdventist Bolingbrook Hospital, Bolingbrook, IL

Background: Patient navigation in cancer care refers to the individualized care provided to cancer patients,families, and caregivers to ease multiple barriers and facilitate timely access to qualified medical and psy-chosocial care. The relatively new patient navigation concept has become a healthcare buzzword asorganizations strive to increase program efficiencies and system retention rates. Objectives: The purpose of this study is to evaluate the optimization of our regionalized imaging/oncologypatient navigation service program. Specifically, the evaluation process examines imaging/oncology volumes,retention rates, and integration rates of our service lines after 2 years of patient navigation implementation. Methods: We performed our review and evaluation through the following initiatives. Identify key stakehold-ers, patient groups, and current resources. Define the scope of the patient navigation involvement, jobdescription, necessary educational preparation, and expectations. Identify the current patient navigationprocess. Identify gaps, obstacles, and barriers to patients and families. Determine program scope, cost,and implementation strategy. Perform a needs assessment. Develop a plan to address and bridge weak-nesses in current process. Implement strategies. Develop program outcome measures based on identifiedgaps and national quality of care standards. Evaluate for future goals. Results: Immediate onset of patient navigation services, timely treatment, and follow-up remain pivotal inpatient satisfaction, outcome measures, retained volumes, quality improvements, and cost-effectiveness. Ourrecall rate, positive predictive value, false predictive value, and cancer detection rate are well controlledand mirror or better the benchmark data. Our imaging volumes and surgical/oncology volumes haveincreased. Two of our 3 centers have earned the national accreditation programs for breast centers. Thepatient navigation employees have been nationally certified in patient navigation from the NationalConsortium of Breast Centers in breast imaging as well as cancer care. Conclusion: Performing a systematic evaluation is vital in the identification of the program’s strengths andweaknesses. Regionally, our combined efforts have strengthened our cohesiveness and raised the bar witha friendly competitive spirit.

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for cancer centers are registered nurses.4 The jobclass decision is due to the multifaceted responsi-bilities involved in patient navigation – a nursepractitioner or an advanced practice nurse with anoncology pedigree is best suited for the role.2Working closely with imaging, we have a balanceof nurse navigators, radiology technologist naviga-tors, and volunteer navigators to properly roundout our team.The goal for this study and for the strategic

growth of our breast care service line is to take acloser look and to identify our current process andpotentially redefine the feasibility and scope of ourservice line at all levels. Our organization is awareof the breast cancer program accreditation stan-dards, the need for careful oversight of clinicaldevelopment, and the importance of central datamanagement and development. The intention iscertainly to have the special breast imaging servic-es that will meet our patients’ needs. The facility isworking on offering the patient an appointment asquickly as possible with 1 call. The vision is tostreamline care and reach for patient empower-ment, education, and informed decisions. Toaccomplish this vision, a plan has been created to incorporate a cohesive collaborative teamapproach. The center has designated 1 phonenumber for the patient to call. The line is specifi-cally for the breast center patients and internallytriaged accordingly. The patient is seen within 7days. Initially, she meets with a breast physicianand an advanced practice nurse. An initial treat-ment plan is established, providing educationalinformation and resources and individualized sup-port. This is the beginning of the patient naviga-tion relationship. This navigational partner con-nection solidifies the patient’s care with discussedtouch points between multiple modalities.4

STUDY DESIGNObjectiveThe purpose of this study was to evaluate ourregional imaging/oncology patient navigationservice program. Specifically, the evaluationprocess examined imaging/oncology volumes,retention rates, and integration rates of our serv-ice lines after 2 years of phased-in patient navi-gation implementation.

MethodsThe current study was conducted in 3 suburbanMidwest hospitals that are part of the same not-

for-profit privately owned healthcare system head-quartered in the United States. As part of ourreview and evaluation, we identified our key stake-holders, patient groups, and current resources.These groups include all members of breast careleadership, oncology leadership, and current refer-ral relationships.

A convenient sample of breast biopsy patientswithin our region was included in our study. Thesample consisted of all patients who had BreastImaging Reporting and Data System (BIRADS)scores of 4, 5, or 6 (suspicious abnormality, high-ly suggestive of malignancy, and known biopsy-proven malignancy, re spectively5) who weremoving forward and consenting to a breast biop-sy.6 Each patient included in the study had beena breast biopsy patient at 1 of the 3 hospitalswithin a 2-year time frame, specifically fromJanuary 2009 through December 2010. The sam-ple size was 1278, ensuring a sufficient sample wasreferred to the patient navigators.3 The scope ofthe patient navigator involvement had a definedstarting point, the breast biopsy recommenda-tion, and an ending point encompassing thepatient’s extended treatments, resources, andother referrals needed post breast biopsy. Thepatient navigator continued with her patientthroughout the treatment phase, reinforcing thesurveillance and survivorship programs. Com -munity referrals and resources were encouragedby the navigator to fortify a consistent ongoingsupport structure for the patient. Survivorshiptouch points will keep the navigator and thepatient in contact throughout her life. Defining the ending point for navigation can

be unclear. Though 85% of women diagnosedwill be long-term survivors and the mortalityrate has been inching down over the past fewyears, this disease still took the lives of 41,000women and men in the United States in 2010.6There were no exclusion criteria: all patients

“An initial treatment plan is estab-lished, providing educational informa-tion and resources and individualizedsupport. This is the beginning of thepatient navigation relationship.”

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Figure 1: Patient Navigation Process

ACS indicates American Cancer Society; MRS, Mammography Reporting System.

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being recommended for a breast biopsy and com-pleting breast biopsy procedures in our regionwere included. No population was excluded, andpatient referrals to navigation were exclusivelyprovided by our physicians. The job description,necessary educational preparation, and expecta-tions for the role of patient navigator had beendefined prior to the study. These stated expecta-tions and job descriptions remained consistentthroughout the study.

The post discussion and accumulation of dataanalysis for further educational endeavors hadbeen requested and approved by the institutionalreview board for our regional efforts. Content andface validity had been established for all instru-ments by having them reviewed by our stakehold-er physicians, nurses, and other appropriate staff.Furthermore, the cancer registry department con-firmed the validity and reliability of our collecteddata with their data. Their team worked collabora-tively with our study.

RESULTSOutcomes of patient navigation programsreported in the literature include an increase intimely screening services, promotion of timelytreatment after a suspicious finding, improvedadherence to treatment regimens, and increasedpatient satisfaction with care.7 Our evaluationsshow that immediate onset of patient naviga-tion services, timely treatment, and follow-upremain pivotal in patient satisfaction, outcomemeasures, retained volumes, quality improve-ments, and cost-effectiveness. Our recall rate,positive predictive value, false predictive value,and cancer detection rate are well controlledand mirror or better the benchmark data. Figure1 illustrates the patient navigation processimplemented in our region.

Imaging volumes have increased 10% as aregion and 30% in 1 hospital. Figure 2 revealsthe hospital with the largest volume uptake dueto our patient navigation program.

Regionally, our surgical/oncology volumeshave increased 25% and 40% in 1 of our hos-pitals. We have room for improvement on oursurgical turnaround time, re-excision rates,and surgical retention rates. The integrationof our service lines grew exponentially withthe natural addition of patient/community out-reach programs. Figure 3 shows the growth in sur-gical volumes.

This integration has increased credibility andphysician confidence throughout the area. The cli-nicians met the challenge of learning and creatinga blended role,8 and 2 of our 3 centers have earnednational accreditation for breast care centers. Thethird center was actively working to apply in 2011.The patient navigation employees have all beennationally certified in patient navigation from theNational Consortium of Breast Centers in bothbreast imaging and cancer care.

Retention rates following breast biopsy withinthe top 2 hospitals of our region have greatlyimproved since beginning our navigation program.Figure 4 illustrates the difference in the retentionrates before and after starting the navigation rolein our region. In addition, the number of daysbetween the patient’s screening mammogram anddiagnostic mammogram has been dramaticallyreduced from an average of 16.82 days to 9.82 days.

Imag

ing

Vo

lum

es

Figure 2: Adventist Bolingbrook Volumes: Women’s Imaging Center;Volume Increase After Beginning Navigation Program

Sur

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al V

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Figure 3: Adventist Bolingbrook Hospital’s Annual Surgical VolumeReview (Lumpectomy/Mastectomy), Before and After Implementationof Navigation Program

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Figure 5 reflects the improvement in turnaroundtime from screening mammograms to diagnosticmammograms. It became apparent, as expected,that the majority (99%) of our patients werewomen. In addition, the majority (62%) were over50 years of age, and 81% were experiencing theirfirst breast biopsy.Each of the 3 facilities has its individual admin-

istrations, demographic markets, and individualpayer mix.6 The hospitals are in the same regionyet experience a wide variety of patient challenges.Barriers to care vary by geographic location basedon characteristics of the population, such associoeconomic status, ethnic diversity, health sys-

tem organization, services, resources, and patient-specific factors.7The region shares the same quality benchmarks,

cancer registry information, and outcome meas-urements. Our radiologist group is contracted bythe region and shared by all 3 hospitals, providingconsistent readings and the highest quality of care.Our radiologists pride themselves on assigning abreast radiologist lead at each facility.

DISCUSSIONBased on the findings of this study, the individualhospitals have been able to look more closely atindividual operations. The study demonstratesthere are some clear operational differences indi-cated by the biopsy retention rates, surgical reten-tion rates, and the turnaround times. With thisobjective observation, we can heighten ourinsight and work more effectively, individuallyand as a group. This study has piqued discussion,strengthened our work relationships, and support-ed sharing information across many departments. Analysis of these data commands the quest for

more studies. Identifying gaps as a result of thisstudy elevates credibility and validity for patientnavigation. Although there is some agreement inthe need for our patient navigation services toexpand, this is only the beginning. We continueto strive for less fragmented care and more per-sonal connection, ideally with 1 navigator.Dem onstrating our value to leadership is criti-cally important, especially in difficult economictimes.3 Our next steps are to address our weak-nesses, expand our services, bridge our gaps, andreevaluate.

RECOMMENDATIONSThere is a need to assess the specific navigationrequirements for breast patients utilizing valid andreliable instrumentation. This information canthen create and provide an educational frameworkstructure for the community outreach programs onan ongoing basis. To extend our regional success,reduce redundancy, develop an acuity system, andincrease seamless communication, navigationalsoftware is highly recommended. Furthermore, theregional recommendation has been to realign thenavigational leadership structure, revamp the nav-igation job descriptions, redefine clear levels ofnavigation, create a volunteer patient navigation-al support team, and provide a strong reportingleadership infrastructure within each hospital. Our

Figure 4: Differences in Breast Biopsy Retention Rates

Figure 5: Turnaround Times: Screening to Diagnostic MammogramsBefore and After the Navigation Process

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multidisciplinary case conferences have becomeinterdisciplinary conferences combining the 2larger hospitals in close proximity. This recom-mendation encourages a team approach andimproves meeting management for everyone. Ourrecommendations for the future include providinghigh-risk assessment and genetic counseling in allof our regional hospitals, and maintaining contin-uing education programs and seminars internallyand externally to strengthen our program.In an effort to sustain our success and build

credibility, the region strives to develop partner-ships with neighboring organizations, engagephysicians in the navigation processes, and refineour current patient navigation model. Our strate-gy is to develop our programs and increase foottraffic in our hospitals. We plan to fortify ourdownstream revenue, retain our current volumes,and cultivate new growth.

LIMITATIONSThis study was generated by a convenient region-al sample for 2 years. A longer-term controlledstudy with a larger population would be useful.The study instruments have been developed bystaff within the region and are available to admin-istration, physicians, and staff. The increasedaccessibility and availability can be greater ifoffered to others via the Internet.

CONCLUSIONPerforming a systematic evaluation is vital inthe identification of our matrix continuum ofpatient navigation’s interdisciplinary care. Thecookie cutter is ineffective. Tailored individual-ity is woven into the success of the patient’snavigation tapestry. Despite the added cost ofthe patient navigator’s salary, the program isfinancially sound and self-supporting. Dynamicpatient navigation must continue to evolve andredefine itself to remain relevant.Our approach is based on a wellness model, not

a cancer center model. Our patient focus is ourleadership strength, and our journey begins withthe patient’s first visit, her screening mammogram.Due to our navigation program success, the regionis considering broadening patient navigation serv-ice models to all oncology service lines. Breast can-cer can be described as a microcosm of the oncol-ogy services provided in our region and a

springboard template for our innovative businessstrategy. We look to build our tangible and intan-gible assets: downstream revenue, market share,reputation, and patient satisfaction.Essentially, the patient navigation program

improves volumes and patient/physician satisfac-tion and identifies opportunities for potential pro-gram development. Patient navigation continuesto evolve as an influential component of breastcancer care. g

AcknowledgementsThe author gratefully acknowledges the interdiscipli-nary team at Adventist Midwest Health who providedcare, resources, and services to assist the goals andobjectives of this study. This article would not havebeen possible without the assistance of Jason C.Goliath, MD; Clarissa Moholick, MHSA, CCRP,CTR; and Linda Wild, RN, CBPN-IC.

DisclosuresJeannine Arias, RN, MBA, MSN, CBCN, CBPN-IC, is employed by Adventist Bolingbrook Hospital.

REFERENCES1. Wilcox B, Bruce SD. Patient navigation: a “win-win” for allinvolved. Oncol Nurs Forum. 2010;37:21-25.2. Pedersen A, Hack TF. Pilots of oncology health care: a conceptanalysis of the patient navigator role. Oncol Nurs Forum.2010;37:55-60.3. Hoelz TM, Sladek ML, Michaelson PL. Blending nursing rolesin oncology and imaging: an innovative strategy. Oncol NursForum. 2007;34:27-31.4. Shockney LD. Becoming a Breast Cancer Nurse Navigator.Sudbury, MA: Jones and Bartlett Publishers; 2011.5. Stephan P. BIRADS – Breast Imaging Reporting and DataSystem. http://breastcancer.about.com/od/diagnosis/a/birads_2.htm. Updated July 2, 2011. Accessed August 15, 2011.6. Shockney LD. Navigating Breast Cancer: A Guide to theNewly Diagnosed. 2nd ed. Sudbury, MA: Jones and BartlettPublishers; 2011.7. Shockney LD, Tsangaris TN. The Johns Hopkins Breast CancerHandbook for Healthcare Professionals. Sudbury, MA: Jones andBartlett Publishers; 2007.8. Campbell C, Craig J, Eggert J, et al. Implementing and measur-ing the impact of patient navigation at a comprehensive communi-ty cancer center. Oncol Nurs Forum. 2010;37:61-68.

“Despite the added cost of the patient navigator’s salary, the program is financially sound andself-supporting.”

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WEB SITEREVIEW

22 FEBRUARY 2012 • VOLUME 3, ISSUE 1 AONNONLINE.ORG

T he mission of the National Breast CancerFoundation is to save lives through earlydetection and to provide mammograms for

those in need. The goals of the foundationinclude increasing awareness through education,providing diagnostic breast care services forwomen who cannot afford them, and providingnurturing support services. For some breast carecenters, this support has included the funding orpartial funding of nurse navigators.A special feature of the organization’s Web site,

called Beyond the Shock, offers a global onlineeducational resource that includes easy-to-under-stand informational videos, stories from breastcancer survivors, and a community Q&A. So ifyour patients, their families, or you want to learnmore about breast cancer, ask questions and getanswers, or hear real stories from real people,check it out.Patients/survivors can also receive a free

newsletter from the organization by signing up ontheir Web site. g

BEYOND THE SHOCK: An Online Resource From the National Breast CancerFoundation By Lillie D. Shockney, RN, BS, MAS

For more information visit: www.nationalbreastcancer.org/ or http://beyondtheshock.com/

www.AONNonline.org/conference/2012

September 14-16, 2012 • Phoenix, Arizona

Third Annual Navigation and Survivorship ConferenceSAVE THE DATE

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