Anew concept of self-seeding of cancer by cir-culating cells returning to the original tumorsmay help to inform some long-standing prob-lems in cancer biology and treatment, including whychemotherapy may often be only partially effective.

Sharon S. Gentry, RN, MSN,AOCN, is a nurse who hasbraved unchartered watersherself by organizing her centers firstnurse navigation program afterdevoting 20 years to nursing on theinpatient oncology unit. She nowhelps breast cancer patients navigatetheir own journey as a breast nursenavigator at the Derrick L. Davis

Forsyth Regional Cancer Center inWinston-Salem, NC. Gentry is oneof a growing number of nurses whoguide cancer patients through andaround barriers in the complex can-cer care system, including lack ofinformation, gaps in care, and needfor financial help, social support, ortransportation. Nurse navigators notonly help to ensure timely treat-

ment, but provide their support in amanner that is compassionate, re-spectful, and culturally sensitive.

At the Derrick L. Davis ForsythRegional Cancer Center, in 2001Gentry started the seamless threadthat ties together the centers com-munity-based breast cancer care,

DECEMBER 2008 VOL. 1, NO. 6 www.theoncologynurse.com

2008 Green Hill Healthcare Communications, LLC

PRACTICALAPPLICATIONSClinical advances in the treatment of myelodysplasticsyndromes

Between pages 18 and 19

NURSING CAREERSNursing career specialist increases recruitment, retention

page 27

NURSE NAVIGATORS

Continued on page 9

Quality of Life in MetastaticRenal Cell Carcinoma:

Sunitinib vs Interferon alfa

Continued on page 17

CANCER CONCEPTS

Navigating the Journey of Breast CancerAn interview with Sharon S. Gentry, RN, MSN, AOCN

NURSING PRACTICE

Study Suggests DevastatingConsequences of Smokingon the Nursing Profession

Continued on page 10

NURSING LIFE

SEATTLEFor the first time, researchers have lookedat smoking and the nursing profession and the findingsare rather surprising. The study shows a dichotomybetween what nurses advise their patients and whatthey do themselves. It also emphasizes the importanceof supporting smoking cessation programs for nurses.

Nurses witness firsthand how smoking devastatesthe health of their patients with cancer and respiratoryand cardiovascular diseases, said principal investigatorLinda Sarna, DNSc, a professor at the University of

A t the 2008 Annual Meeting of the AmericanSociety of Clinical Oncology, chair TeresaGilewski, MD, medical oncologist, BreastCancer Service, Department of Medicine, MemorialSloan-Kettering Cancer Center (MSKCC), New York,introduced an educational session entitled Integrating

Integrating theHumanistic and ScientificAspects of Patient Care

Continued on page 5

Cancer Self-seeding: New Concept May Explain Why What Goes Around

Comes Around

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Oncology nurses may want to warn their breast cancer patients whoare taking aromatase inhibitors to think twice before taking a soy-baseddietary supplement. Researchers at the University of Illinois havefound that genistein, a soy isoflavone that mimics the effects of estro-gen in the body, can negate the effectiveness of aromatase inhibitors,which are designed to reduce the levels of estrogens that can promotetumor growth.

Aromatase inhibitors work by interfering with the enzyme aro-matase, which catalyzes a crucial step in converting precursor mole-cules to estradiol. About two thirds of all cases of breast cancer diag-nosed in the United States are estrogendependent or estrogen sensitive, whichmeans that the tumors grow more rapidlyin the presence of estrogen.

The researchers conducted several tri-als in animal models using the widely pre-scribed aromatase inhibitor letrozole(Femara). They found that when genis-tein (a plant estrogen or phytoestrogenpresent in many dietary supplements) wasgiven with letrozole, there was a dose-dependent reduction in the effectivenessof the breast cancer drug. Specifically, thetumors began to grow again and theygrew the fastest at the highest dietarydoses of genistein.

To think that a dietary supplementcould actually reverse the effects of avery effective drug is contrary to much ofthe perceived benefits of soy isoflavones,and unsettling, said principal studyinvestigator William Helferich, who is aprofessor of food science and humannutrition at the University of Illinois,Champaign. You have women who aretaking these supplements to amelioratepostmenopausal symptoms and assumingthat they are as safe as consuming a cal-cium pill or a B vitamin.

Many women currently take genisteinsupplements to control hot flashes andother symptoms of menopause. TheIllinois researchers found that the dosescommonly available in dietary supple-

ments were potent enough to negate the effectiveness of aromataseinhibitors.

These compounds have complex biological activities that are notfully understood. Dietary supplements containing soy-based phytoes-trogens provide high enough dosages that it could be a significant issueto breast cancer patients and survivors, said Helferich. We are juststarting to understand the complex effects of the dietary supplementsthat contain phytoestrogens.These findings raise serious concernsabout the potential interaction of the estrogenic dietary supplementswith current breast cancer therapies. [See related story on page 17.]

Nurses can play an important role in improving the manage-ment of cancer-related fatigue by addressing the problem early inthe course of treatment, according to researchers at the CancerInstitute of New Jersey (CINJ). The investigators also have foundthat a self-care fatigue diary may be beneficial.

Empowering the patient with information andeducation related to symptoms of fatigue is impor-tant, said Beth Knox, MSN, RN, APN-C, AOCN,an adult oncologycertified nurse practitioner at theCINJ, New Brunswick, NJ. We need more educa-tion and the patients need to be educated beforetheir chemotherapy begins, and this often does nothappen. The patients are not empowered withenough information to manage their fatigue symp-toms throughout the course of their treatment.

Knox and her colleagues are conducting a sup-portive care trial focused on the use of a self-care fatigue diary.The study addresses use of the diary to help manage chemothera-py-induced side effects, such as fatigue, and associated symptoms.One of the primary aims of the study is to measure patient/provider satisfaction in the management of cancer-related fatigue.Knox contends that many patients are inadequately treated forcancer-related fatigue because of the significant communication

barriers that currently exist. She said this is a problem at institu-tions all across the United States.

I think that there are barriers because patients feel the doctorsare not interested or dont have specific recommendations that

they give patients. Patients have fear of dis-cussing fatigue because they fear that the dis-ease has progressed and that is indicated by thefatigue. Also, there is a fear about it jeopardiz-ing their ability to stay on their cancer treat-ment, said Knox. Another issue is that manypatients want to limit their medications, andso they dont want to get more medications.They may worry that can happen if they bringup their problems with fatigue.

Knox said the use of a self-care fatiguediary can help address some of these issues by

improving communication between patients and providers. Shesaid it is important that nurses bring up these issues as early aspossible. Knox said oncology nurses should try to help patientsaddress the physical, emotional, spiritual, practical, social, andfinancial effects of cancer. By doing this, she said it may be pos-sible to improve a patients comfort and reduce symptoms thatmay cause pain and diminish quality of life.

Medical MinutesBY JOHN SCHIESZER

John Schieszer is an

award-winning national

journalist and radio

broadcaster of The

Medical Minute.

He can be reached at

medminutes@aol.com.

Improving the Management of Cancer-related Fatigue

Dietary Supplement Genistein May Undermine Breast Cancer Treatment

Early cancer detection can significantlyimprove survival rates. Current diagnostictests, however, often fail to detect cancer inthe earliest stages and at the same timeexpose a patient to the harmful effects ofradiation. Now, researchers in Oklahomaare hoping to use mid-infrared lasers todetect biomarker gases exhaled in the breathof a person with cancer to pick up their can-cer earlier.

Proof-of-concept detection of a suspectedlung cancer biomarker in exhaled breath hasalready been established by the Oklahomaresearchers. Their research was inspired bystudies showing that dogs can detect cancerby sniffing the exhaled breath of cancerpatients. In a study reported in the March2006 issue of Integrative Cancer Therapies,researchers found that by sniffing theexhaled breath of patients with cancer, dogscould identify breast cancer and lung cancerpatients with accuracies of 88% and 97%,respectively.

A device that measures cancer-specificgases in exhaled breath would change med-ical research as we know it, said PatrickMcCann, a professor in the College of

Engineering at the University of Oklahoma,Norman.

He said it appears that it is possible todevelop easy-to-use detection devices forcancer, particularly for hard-to-detect can-cers like lung cancer. In the future, oncologynurses may be able to use these devices atthe bedside to help diagnose and guide themanagement of patients with cancer.

Improved methods to detect moleculeshave been demonstrated, and more peopleneed to be using these methods to detectmolecules given off from cancer. We havedeveloped laser-based methods to detectmolecules. Mid-infrared lasers can measuresuspected cancer biomarkers: ethane,formaldehyde, and acetaldehyde, saidMcCann. However, more capital andresearch infrastructure are needed for thisdevice to become a reality.

He is currently using nanotechnology toimprove laser performance and shrink thelaser systems, which would allow battery-powered operation of a handheld sensordevice. McCann said, however, it would beat least 5 years before a low-cost device likethis could be available in the clinic.

Cancer Breath: Detecting Cancer Earlier Through Exhaled Air

December 2008 GREEN HILL HEALTHCARE COMMUNICATIONS 1

2 GREEN HILL HEALTHCARE COMMUNICATIONS December 2008

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OncologyNurse

TheOncologyNurse

The

The Official Newspaperof Record for

the Hem/Onc Nurse

PUBLISHING STAFF

PublisherPhilip Pawelkophil@greenhillhc.com

Editorial DirectorKaren Rosenbergkaren@greenhillhc.com

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Associate EditorDawn Lagrosa

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Directors, Client ServicesJohn W. Hennessyjohn@greenhillhc.com

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Vol. 1, No. 6 December 2008

Green Hill Healthcare Communications LLCGreen Hill Healthcare Communications, LLCHG Your Innovative Partners in Medical Media

Departments

1 Medical Minutes

4 Editors Letter

6 News Notes

16 Recent FDA Approvals

28 Books and Media

37 Meetings

Isabell Castellano, RN

Bristol-Myers Squibb Childrens Hospital

Robert Wood Johnson University Hospital

New Brunswick, NJ

Deena Damsky Dell, RN, MSN, AOCN, BC

Fox Chase Cancer Center

Philadelphia, PA

Wendy DiSalvo, BSN, MSN, FNP, AOCN

Dartmouth Hitchcock Medical Center

Norris Cotton Cancer Center

Lebanon, NH

Denice Economou, RN, MN, AOCN

City of Hope National Medical Center

Duarte, CA

Constance Engelking, RN, MS, OCN

The CHE Consulting Group, Inc.

Mt. Kisco, NY

Amy Ford, RN, BSN, OCN

Creative Cancer Concepts, Inc.

Rockwall, TX

Lyssa Friedman, RN, MPA, OCN

Veracyte, Inc

South San Francisco, CA

Sharon S. Gentry, RN, MSN, AOCN

Derrick L. Davis Forsyth Regional Cancer Center

Winston-Salem, NC

Marilyn L. Haas, PhD, RN, CNS, ANP-C

Mountain Radiation Oncology

Asheville, NC

Cassandra J. Hammond, RN, MSN, CRNP

Avid Education Partners, LLC

Sharpsburg, MD

Taline Khoukaz, NP, MSN, ACNP-C

University of Southern California

Norris Cancer Center & Hospital

Los Angeles, CA

Sandra E. Kurtin, RN, MS, AOCN, ANP-C

Arizona Cancer Center

Tucson, AZ

Ann McNeill, MSN, RN, NP-C, OCN

The Cancer Center at Hackensack University

Medical Center

Hackensack, NJ

Kena C. Miller, RN, MSN, FNP

Roswell Park Cancer Institute

Buffalo, NY

Dolores Jeff Nordquist, RN, MS, CS, FNP

Mayo Clinic

Rochester, MN

Melinda Oberleitner, RN, DNS, APRN, CNS

College of Nursing and Allied Health Professions

University of Louisiana

Lafayette, LA

Gary Shelton, MSN, ARNP, AOCNNYU Cancer InstituteNew York, NY

Lori Stover, RN, BSNWestern Pennsylvania Cancer Institute Pittsburgh, PA

Joseph D. Tariman, RN, MN, ARNP-BC, OCNUniversity of Washington School of Nursing Seattle, WA

Pamela Hallquist Viale, RN, MS, CS, ANP, AOCNSaratoga, CA

Connie Visovsky, RN, PhD, APRNUniversity of Nebraska, College of NursingOmaha, NE

Jeanne Westphal, RNMeeker County Memorial HospitalLitchfield, MN

Rita Wickham, OCN, PhD, RNRush University College of NursingRush-Presbyterian-St. Lukes Medical CenterChicago, IL

Karla Wilson, RN, MSN, FNP-C, CPONCity of Hope National Medical CenterDuarte, CA

OTHER SPECIALTIES

Susan Goodin, PharmD, FCCP, BCOPCancer Institute of New JerseyNew Brunswick, NJ

Barbara Savage, LISWCleveland Clinic Taussig Cancer InstituteCleveland, OH

Amanda Saldivar, MS, RD, LD Cleveland Clinic Taussig Cancer InstituteCleveland, OH

OncologyNurse

TheOncologyNurse

The

The Official Newspaperof Record for

the Hem/Onc Nurse

EDITORIAL BOARD

EDITOR-IN-CHIEF

Beth Faiman, RN, MSN, APRN, BC,

AOCN

Cleveland Clinic Taussig

Cancer Institute

Cleveland, OH

Feature Articles11 Supportive Care

Oral rinse may benefit head/neck chemoradiation patients

12 Safe HandlingInstituting safeguards and efficiencies

15 Hematologic CancersNon-Hodgkins lymphomas, Part 2: Pathobiology

17 Breast CancerRetesting breast cancer recurrences

19 Bone MetastasesStrength training prevents bone loss in breast cancer patients

20 Cancer Center ProfileFox Chase Cancer Center

27 Nursing CareersThe nursing career specialist

30 Continuing EducationQuality of life in metastatic renal cell carcinoma: sunitinib vs

interferon alfa

34 Supportive CarePathfinders guides patients along cancer landscape

35 Nursing PracticeThe oncology nurse as patient advocate

Practical ApplicationsClinical advances in the treatment of

myelodysplastic syndromes

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T he latest cancer statistics areencouragingfor the first time,both rates of new cancer diagnosesand deaths from cancer have declined inthe US population as a whole. The declinesare attributed in part to healthier lifestylesas well as advances in diagnosis and treat-ment. Of concern, however, is the increasein lung cancer in women. As recent resultsfrom the Nurses Health Study show, smok-ing is a concern for ourselves as well as ourpatients. With our busy, often stressfullives, it is easy to fall back into old habitslike smoking or lack of exercise, but, inorder to set a good example for our col-leagues, our patients, and the communityin which we live, we must practice what wepreach. Nurses are in an excellent positionto lead efforts to curb smoking and promotehealthy lifestyles in general.

Much positive news about advances incancer diagnosis and treatment was reportedat recent meetings of the American Societyof Hematology, The Oncology NursingSociety, the European Society of MedicalOncology and will be reviewed in this andcoming issues. One notable example ismyelodysplastic syndrome, as the article bySandra Kurtin eloquently explains. For thefirst time, data are now available showingprolonged survival with newer therapies,offering new hope for patients, their families,and their caregivers. Another good exampleis progress in the treatment of metastaticrenal cell carcinoma, with new therapies thatare not only more effective than previousagents but also offer patients an improvedquality of life.

Despite all this good news, a diagnosis ofcancer can be devastating for the patient

and the variety of treatment choices bewil-dering. Patients often need someone toguide them in making decisions abouttreatment and coping with the emotional,financial, insurance, employment, andother issues that arise at the time of diagno-sis and throughout the course of the diseaseand survivorship. To meet this need, a newspecialty in nursing is emergingthe nursenavigator. The interview with SharonGentry, one of the leaders in this move-ment, is the first in a series in The OncologyNurse that will follow developments in thisfield, including formation of a nationalorganization of oncology nurse navigatorsand the role of nurse navigators in treat-ment of various types of cancer. If you wouldlike to share your own experience as a nursenavigator with our readers, please write toKaren@greenhillhc.com.

A Letter from the Editor

BETH FAIMAN, RN, MSN,APRN, BC, AOCN

EDITOR-IN-CHIEF

EDITORIAL CORRESPONDENCE should be addressed toEDITORIAL DIRECTOR, The Oncology Nurse, 241 ForsgateDrive, Suite 205C, Monroe Twp, NJ 08831. E-mail: karen@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States andpossessions: individuals, $105.00; institutions, $135.00; single issues$17.00. Orders will be billed at individual rate until proof of status isconfirmed. Prices are subject to change without notice.Correspondence regarding permission to reprint all or part of anyarticle published in this journal should be addressed to REPRINTPERMISSIONS DEPARTMENT, Green Hill HealthcareCommunications, LLC, 241 Forsgate Drive, Suite 205C, MonroeTwp, NJ 08831. The ideas and opinions expressed in The OncologyNurse do not necessarily reflect those of the Editorial Board, theEditorial Director, or the Publisher. Publication of an advertisementor other product mention in The Oncology Nurse should not be con-strued as an endorsement of the product or the manufacturers claims.Readers are encouraged to contact the manufacturer with questionsabout the features or limitations of the products mentioned. Neitherthe Editorial Board nor the Publisher assumes any responsibility forany injury and/or damage to persons or property arising out of orrelated to any use of the material contained in this periodical. Thereader is advised to check the appropriate medical literature and theproduct information currently provided by the manufacturer of eachdrug to be administered to verify the dosage, the method and durationof administration, or contraindications. It is the responsibility of thetreating physician or other healthcare professional, relying on inde-pendent experience and knowledge of the patient, to determine drugdosages and the best treatment for the patient. Every effort has beenmade to check generic and trade names, and to verify dosages. Theultimate responsibility, however, lies with the prescribing physician.Please convey any errors to the Editorial Director. ISSN #1944-9798.

The Oncology Nurse 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. Copyright 2008 by Green Hill HealthcareCommunications, LLC. All rights reserved. The Oncology Nurse logois a trademark of Green Hill Healthcare Communications, LLC. Nopart of this publication may be reproduced or transmitted in any formor by any means now or hereafter known, electronic or mechanical,including photocopy, recording, or any informational storage andretrieval system, without written permission from the Publisher.Printed in the United States of America.

ComingSoon

CE article:

Decision Aids as a Guide for Cancer Patients in

Clinical Decision-making

New Technologies in HER2 Testing

Increasing Oncology Patient Participation inClinical Trials: The Coalition of Cancer

Cooperative Groups

Recognizing Structural Oncologic Emergencies

Early Detection of Lymphedema in Breast Cancer Patients

Reports from ONS Institutes of Learning, American Society of Hematology, San Antonio

Breast Cancer Symposium

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4 GREEN HILL HEALTHCARE COMMUNICATIONS December 2008

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the Humanistic and Scientific Aspectsof Patient Care: The Perspective ofSeasoned Surgical, Medical, Pediatric,and Radiation Oncologists. She fol-lowed the presentation with a 30-minutevideo she produced containing inter-views with 11 physicians, a medical resi-dent, and a pre-med student.

A challenging issueGilewski sees both science and

humanism as integral components ofmedicine, but feels that because thehumanistic aspects are difficult toquantify, they receive less attentionand will require innovative approach-es like her video, which she hopes willeventually be available for viewing bya wider audience. The interviewees allseemed to feel that the process of inte-grating science and humanism inpractice was difficult, although thereasons for this were not entirelyclear. Kathleen Foley, MD, an inter-viewee who is a neurologist atMSKCC, believes that humanisticbehavior can be learned, but if practi-tioners cannot learn the behavior,then they can certainly learn to modelhumanistic behavior. This puts someresponsibility on those who trainhealthcare providers, in either class-room or clinical settings, to teach byexample.

The physicians perspectiveHyman Bernard Muss, MD, professor

of medicine, University of Vermont andVermont Cancer Center, Burlington,presented the perspective of a medicaloncologist. He observed that althoughthe oncologist often becomes thepatients primary care physician, theteam concept, which includes construc-tive interaction with nurses and otherhealthcare providers, is foreign to manyoncologists. One obstacle to a human-istic approach to patient care, he said,is the continuing computerization ofmedical care, which will require a con-scious effort on the part of physiciansto continue to provide compassion,empathy, guidance, reassurance, andcomfort. Another obstacle he believes isthe lifestyle gap between todays doctorsand patients. What he has found helpfulis to make a conscious effort to sit downand listen, to start patient encounterssaying, Now tell me about yourself.

Melissa M. Hudson, MD, St. JudeChildrens Research Hospital, provideda pediatric perspective. At St. Judes,she observes, [we] are not driven by thebottom line and can spend whatevertime is needed with patients. She seeksto understand the patients, the familyperspective, their community and cul-ture, and to be sensitive to their per-spective, even if it is not her own. Youdont know what the patients and fami-ly are going through. You need toacknowledge their unique fears anduncertainty, be open-minded andpatient to questions, then be patientwith more questions, anticipate whatthey do not hear, and collaborate to findanswers and solutions, Hudson says.

The oncologist may think a treatmentis well-tolerated, but the patient maynot. She sees humanism in practice asfocusing care on the patient, not the dis-ease. This requires evaluation of allaspects: physical, emotional, social, andfinancial, something she thinkspediatricians excel at.

Hudson noted issues thatirritate her in medical situa-tions, including unexplaineddelays, provider inaccessibility,rushed interactions, lack of orpoor communication, lack ofrespect for privacy or dignity(eg, having a prolonged discus-sion with a patient in a gown),and which should be avoided.She also emphasized thathealthcare providers shouldacknowledge the limits of theirknowledge, time, and energy,and tell patients when they donot know something and thatthey will get back to them. Thebenefits of this approach areenhanced communication, acollaborative relationship withthe patient, respect for providertime and effort, care satisfac-tion, and a willingness to for-give shortcomings. These benefits, how-ever, come at the expense of extra timespent, as well as emotional and physicaldemands on practitioners.

Jay R. Harris, MD, a radiation oncol-ogist at the Dana-Farber Cancer Center,Boston, sees humanism in medicine as ademonstration to patients that there is acommitment to understand their psy-chosocial as well as medical issues, andto convince patients he cares aboutthem. He thinks patients need thisbecause they are often more fearful ofthe short- and long-term effects of radia-tion therapy than they are of surgery andmedical treatment. He notes that thepractice of radiation oncology dependson teamwork and positive interactionsbetween physicians and nurses.He observes that at HarvardMedical School, radiationoncology is a popular fieldbecause of the quality and quan-tity of time students get tospend with patients.

The perspective of the surgi-cal oncologist was presentedby Murray F. Brennan, MD, asurgeon at MSKCC, who saidthat humanism should not betaught as a course, but byexample in patient care, whereit begins with the first consul-tation and never ends. He said,Do not promise what youcant deliver when communi-cating with a patient, particu-larly when the patient expectsa miracle and you cant deliverit. This extends to not promis-ing what colleagues, like med-ical or radiation oncologists,also cant deliver. Anyone cantell a patient the surgery wentwell. The surgeon needs to bethere to tell the patient the

cancer was inoperable or he couldntget it all. This sort of situationrequires both the patient and health-care provider to organize theirthoughts to balance optimism withreality.

The nurses perspectiveRuth McCorkle, PhD, FAAN, pro-

fessor of nursing, Yale School of Nurs-ing, and program leader for cancercontrol at the Yale ComprehensiveCancer Center, thinks its ironic wehave to talk about being humanistic. Itshould be part of what we are. Whenasked how to help people be morehumanistic, McCorkle responds, Alot is just basic kindness. McCorkleteaches a course in living and dying.The unfortunate part is that its anelective. Its still quite amazing to methat its not required, she says. Shenoted that at the Yale School ofNursing this fall there will be an end-of-life workshop. This is absolutely a

topic for continuing nursing educa-tion, she emphasizes.

McCorkle cited the Institute ofMedicine (IOM) study report, CancerCare for the Whole Patient: MeetingPsychosocial Health Needs, published in

2007, which established that carethat does not address patientsmental and emotional well-beingis not quality care. The IOMCommittee on PsychosocialServices to Cancer Patients/Families in a Community Settingincluded Drs McCorkle andHudson, as well as psychiatrists,physicians, social workers, policyexperts, oncologists, and nursingschool faculty. The report de-scribes the lack of attention topatients psychosocial health incancer care, and the feelingamong patients that theirhealthcare providers do notunderstand their psychosocial

needs, do not consider support as inte-gral to their care, are unaware of avail-able resources, and do not either recog-nize and treat patients psychosocialproblems or refer them to appropriatetreatment. The IOM Committee hasidentified six domains of patient psy-chosocial problems as well as the serv-ices needed to address them and hasdescribed a standard of care based oneffective communication, identifica-tion of patient needs, and implemen-tation of a plan to address thoseneeds. The report is available athttp://www.iom.edu/CMS/3809/34252/47228.aspx.

Lynne Lederman

Integrating Aspects of Patient CareContinued from cover

She sees humanism in practice as focusingcare on the patient, not the disease.

iStockphoto.com/Dr. Heinz Linke

Cancer Rates Fall in United StatesFor the first time since reporting

began in 1998, both overall cancerincidence and mortality havedecreased significantly in men andwomen and in most racial and ethnicgroups in the United States.According to a report issued by theAmerican Cancer Society, theCenters for Disease Control andPrevention, the National CancerInstitute, and the North AmericanAssociation of Central CancerRegistries, the incidence and mortal-ity of the three most common can-cers among men (lung, colorectal,and prostate) and two of the mostcommon among women (breast andcolorectal) decreased. Lung cancerincidence and death rates, however,rose in women in 18 states, mostly instates in the South or Midwest thathave not passed antismoking laws. Incontrast, California, where smokingis banned in workplaces and otherpublic places, is the only state inwhich lung cancer rates declined.The findings, the authors say,underscore the need to maintainand strengthen many state tobaccocontrol programs. (J Natl CancerInst. 2008;100:1672-1694.)

Suboptimal RadiotherapyLinked to Higher Risk ofRecurrence, DeathWomen who postpone radiothera-

py (RT) or do not complete the fullradiation regimen after breast-con-serving surgery are at significantlyincreased risk of recurrence or death,researchers at Weill Cornell MedicalCollege in New York report. Theyreviewed the medical records of 7791women 66 years or older with stage Ibreast cancer or ductal carcinoma insitu; 16% postponed RT and 3% didnot complete the full regimen. Therisk of a subsequent breast cancerevent was 1.4 times higher inpatients with stage I breast cancerwho waited 8 weeks before startingRT, and four times higher in womenwho delayed 12 weeks or longer.Patients who had a truncated courseof RT (defined as less than 3 weeksinstead of the usual 5 to 7 weeks) hada 32% greater overall mortality rate,the researchers found. (Cancer.2008;113:3108-3115.)

Free CE Credits Available atCOEXM Web SiteThe Center of Excellence Media

(COEXM) web site offers a variety ofcomplimentary CE programs for oncol-ogy nurses and other members of thecancer care team. To view all availableCE programs and current and pastissues of The Oncology Nurse, please logon to www.coexm.com and click onThe Oncology Nurse at the top of thepage. You can also register to receiveyour free subscription to The OncologyNurse and related publications andobtain guidelines for authors.

Home-based Diet and ExerciseProgram Improves ElderlyCancer Survivors PhysicalFunctionElderly cancer survivors who partici-

pated in a home-based diet and exerciseprogram showed improvements in theirdiet and exercise habits and improvedphysical function scores. Preliminary

results of the Reach-out to EnhanceWellness (RENEW) trial were presentedby Wendy Demark-Wahnefried, PhD, ofM.D. Anderson Cancer Center at theseventh annual American Associationfor Cancer Research Frontiers in CancerPrevention conference. Of 641 partici-pants who were 65 years of age or olderand had been diagnosed with cancer atleast 5 years previously, 319 received theintervention and 322 were waitlisted. Atthe end of the year-long program, whichincluded 15 telephone counseling ses-sions with a personal trainer, those in the

intervention group had increased theirphysical activity to 44.9 minutes perweek compared with 29.7 minutes in thecontrol group and showed improve-ments in strength of their legs and othermeasures of physical function. In addi-tion, the intervention group had a 3%decrease in body weight compared witha 1% drop in the control group.(www.mdanderson.org.)

But Cancer Burden GrowingWorldwideDespite declines in cancer rates in

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When Treating Your Patients:

Evaluate for other treatable etiologies of anemia (iron, folate, or B12deciency, hemolysis, or bleeding) to treat appropriately

PROCRIT therapy should not be initiated at hemoglobin (Hb) levels 10 g/dL

The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest Hb level suf cient to avoid the need for red blood cell (RBC) transfusion

The rate of Hb increase should not exceed 1 g/dL in any 2-week period

Monitor Hb weekly until stable, and then regularly during therapy

For Anemic Cancer Patients With Metastatic, Non-myeloid Malignancies Receiving Chemotherapy

CONTROLTHE RESPONSE

MANAGE HEMOGLOBIN

AND REDUCE TRANSFUSIONS

News Notes

the United States, the global burden ofcancer is increasing and could nearlytriple by 2030, a new report by theInternational Agency for Research onCancer (IARC) shows. At a press con-ference, leaders of the AmericanCancer Society (ACS), Susan G.Komen for the Cure, and the LanceArmstrong Foundation announcedthey will join forces with the IARCand the National Cancer Institute ofMexico to focus attention on thisgrowing worldwide problem. TheACS, Susan G. Komen for the Cure,

and the Lance Armstrong Foundationalso issued a six-point call to actionoutlining steps the new US administra-tion can take to ease the global cancerburden. (www.cancer.org.)

Online Guide to e-PrescribingAvailableBeginning in 2009, the Centers for

Medicare & Medicaid Services (CMS)will offer financial incentives for physi-cians who successfully use e-prescribingsystems. Only about 6% of US physiciansare currently using e-prescribing systems,

according to eHealth Initiative. Thegroup in collaboration with theAmerican Medical Association andother healthcare organizations has pre-pared A Clinicians Guide to ElectronicPrescribing, which is available online(http:www.ehealthinitiative.org/assets/Documents/e-Prescribing_Clinicians_Guide_Final.pdf). The guide includes a

section designed to familiarize physicianswith e-prescribing and its benefits as wellas possible challenges in making thetransition. Another section is designedto guide readers through the implemen-tation process. Information on the CMSe-Prescribing Incentive Program can befound at http://www.cms.hhs.gov/ PQRI/03_EPrescribingIncentiveProgram.asp.

December 2008 GREEN HILL HEALTHCARE COMMUNICATIONS 7

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PROCRIT Indication

PROCRIT is indicated for the treatment of anemia due to the effect ofconcomitantly administered chemotherapy based on studies that have shown a reduction in the need for RBC transfusions in patients withmetastatic, non-myeloid malignancies receiving chemotherapy fora minimum of 2 months. Studies to determine whether PROCRITincreases mortality or decreases progression-free/recurrence-freesurvival are ongoing.

PROCRIT is not indicated for use in patients receiving hormonalagents, therapeutic biologic products, or radiotherapy unless receivingconcomitant myelosuppressive chemotherapy.

PROCRIT is not indicated for patients receiving myelosuppressivetherapy when the anticipated outcome is cure due to the absenceof studies that adequately characterize the impact of PROCRIT onprogression-free and overall survival (see WARNINGS: IncreasedMortality and/or Increased Risk of Tumor Progression or Recurrence).

PROCRIT is not indicated for the treatment of anemia in cancerpatients due to other factors such as iron or folate deficiencies,hemolysis, or gastrointestinal bleeding (see PRECAUTIONS: Lack orLoss of Response).

PROCRIT use has not been demonstrated in controlled clinicaltrials to improve symptoms of anemia, quality of life, fatigue, orpatient well-being.

Important Safety Information

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Renal failure: Patients experienced greater risks for deathand serious cardiovascular events when administerederythropoiesis-stimulating agents (ESAs) to target higher versuslower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL)in two clinical studies. Individualize dosing to achieve andmaintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

ESAs shortened overall survival and/or increased the risk oftumor progression or recurrence in some clinical studies inpatients with breast, non-small cell lung, head and neck,lymphoid, and cervical cancers (see WARNINGS: Table 1).

To decrease these risks, as well as the risk of seriouscardio- and thrombovascular events, use the lowest doseneeded to avoid red blood cell transfusion.

Use ESAs only for treatment of anemia due to concomitantmyelosuppressive chemotherapy.

ESAs are not indicated for patients receiving myelosuppressivetherapy when the anticipated outcome is cure.

Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT (Epoetin alfa) increased the rate of deepvenous thromboses in patients not receiving prophylacticanticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertensionor with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

Patients with chronic renal failure experienced greater risks for death and serious cardiovascular events (including myocardial infarction,stroke, congestive heart failure, and hemodialysis vascular accessthrombosis) when administered ESAs to target higher versus lowerhemoglobin levels (13.5 vs.11.3 g/dL; 14 vs. 10 g/dL) in two clinicalstudies; these risks also increased in controlled clinical trials ofpatients with cancer. A rate of hemoglobin rise of >1 g/dL over2 weeks may contribute to these risks.

PROCRIT therapy should not be initiated at hemoglobin levels 10 g/dL.

The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufcient to avoid the need for blood transfusion.

When the hemoglobin reaches a level needed to avoid transfusion or, increases by more than 1 g/dL in a 2-week period, the PROCRITdose should be reduced by 25%. Withhold the dose of PROCRIT if the hemoglobin exceeds a level needed to avoid transfusion. Restart dose at 25% below the previous dose when the hemoglobin approaches a level where transfusions may be required. Discontinue if after 8 weeks of therapy there is no response as measured by hemoglobin levels or if transfusions are still required.

Monitor hemoglobin regularly during therapy, weekly until hemoglobin becomes stable.

Cases of pure red cell aplasia (PRCA) and of severe anemia, with orwithout other cytopenias, associated with neutralizing antibodies toerythropoietin have been reported in patients treated with PROCRIT; predominantly in patients with chronic renal failure receiving PROCRIT by subcutaneous administration. If any patient develops a sudden lossof response to PROCRIT, accompanied by severe anemia and lowreticulocyte count, and anti-erythropoietin antibody-associated anemiais suspected, withhold PROCRIT and other erythropoietic proteins.Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624)to perform assays for binding and neutralizing antibodies. Iferythropoietin antibody-mediated anemia is confirmed, PROCRITshould be permanently discontinued and patients should not beswitched to other erythropoietic proteins.

The safety and efcacy of PROCRIT therapy have not been established in patients with a known history of a seizure disorder or underlyinghematologic disease (e.g., sickle cell anemia, myelodysplasticsyndromes, or hypercoagulable disorders).

In some female patients, menses have resumed following PROCRITtherapy; the possibility of pregnancy should be discussed and theneed for contraception evaluated.

Prior to and regularly during PROCRIT therapy monitor iron status;transferrin saturation should be 20% and ferritin should be100 ng/mL. During therapy absolute or functional iron deficiency

may develop and all patients will eventually require supplementaliron to adequately support erythropoiesis stimulated by PROCRIT.

Treatment of patients with grossly elevated serum erythropoietinlevels (e.g., >200 mUnits/mL) is not recommended.

During PROCRIT therapy, blood pressure should be monitored carefully and aggressively managed, particularly in patients with an underlying history of hypertension or cardiovascular disease.

Seizures in PROCRIT-treated patients have been reported in thecontext of a signicant increase in hemoglobin from baseline; increasesin blood pressure were not always observed; and patients may havehad other underlying central nervous system pathology.

The most commonly reported side effects (>10%) for PROCRIT inclinical trials were pyrexia, diarrhea, nausea, vomiting, edema,asthenia, fatigue, shortness of breath, paresthesia, and upperrespiratory infection.

Manufactured by: Amgen Inc., Thousand Oaks, California 91320-1789Distributed by: Ortho Biotech Products, L.P., Bridgewater, New Jersey 08807-0914 Ortho Biotech Products, L.P. 2008 11/08 08PCTC2487B 308470

Please see Brief Summary of Prescribing Information, including Boxed WARNINGS, on adjacent page.

News Notes

BRIEF SUMMARY OF PROCRIT PRESCRIBING INFORMATION FOR THE TREATMENT OFANEMIA IN CANCER PATIENTS ON CHEMOTHERAPY

PROCRIT

(Epoetin alfa)FOR INJECTION

FOR FULL PRESCRIBING INFORMATION FOR ALL INDICATIONS,REFER TO THE PHYSICIANS DESK REFERENCE

INDICATIONS AND USAGEPROCRIT is indicated for the treatment of anemia due to the effect of concomitantly administeredchemotherapy based on studies that have shown a reduction in the need for RBC transfusions in patientswith metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of 2 months. Studiesto determine whether PROCRIT increases mortality or decreases progression-free/recurrence-freesurvival are ongoing.

PROCRIT is not indicated for use in patients receiving hormonal agents, therapeutic biologicproducts, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.

PROCRIT is not indicated for patients receiving myelosuppressive therapy when the anticipatedoutcome is cure due to the absence of studies that adequately characterize the impact of PROCRIT

on progression-free and overall survival (see WARNINGS: Increased Mortality and/or Increased Riskof Tumor Progression or Recurrence).

PROCRIT is not indicated for the treatment of anemia in cancer patients due to other factors suchas iron or folate deficiencies, hemolysis, or gastrointestinal bleeding (see PRECAUTIONS: Lack or Lossof Response).

PROCRIT use has not been demonstrated in controlled clinical trials to improve symptoms ofanemia, quality of life, fatigue, or patient well-being.

CONTRAINDICATIONSPROCRIT is contraindicated in patients with: 1. Uncontrolled hypertension. 2. Known hypersensitivity tomammalian cell-derived products. 3. Known hypersensitivity to Albumin (Human).

WARNINGS

Pediatrics

Risk in Premature InfantsThe multidose preserved formulation contains benzyl alcohol. Benzyl alcohol has been reported to beassociated with an increased incidence of neurological and other complications in premature infants whichare sometimes fatal.

AdultsIncreased Mortality, Serious Cardiovascular and Thromboembolic EventsPatients with chronic renal failure experienced greater risks for death and serious cardiovascular eventswhen administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobinlevels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Patients with chronic renal failure and aninsufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events andmortality than other patients. PROCRIT and other ESAs increased the risks for death and seriouscardiovascular events in controlled clinical trials of patients with cancer. These events included myocardialinfarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis. A rate ofhemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.

In a randomized prospective trial, 1432 anemic chronic renal failure patients who were not undergoingdialysis were assigned to Epoetin alfa (rHuEPO) treatment targeting a maintenance hemoglobinconcentration of 13.5 g/dL or 11.3 g/dL. A major cardiovascular event (death, myocardial infarction, stroke,or hospitalization for congestive heart failure) occurred among 125 (18%) of the 715 patients in the higherhemoglobin group compared to 97 (14%) among the 717 patients in the lower hemoglobin group (HR 1.3,95% CI: 1.0, 1.7, p = 0.03).

Increased risk for serious cardiovascular events was also reported from a randomized, prospective trial of1265 hemodialysis patients with clinically evident cardiac disease (ischemic heart disease or congestiveheart failure). In this trial, patients were assigned to PROCRIT treatment targeted to a maintenancehematocrit of either 42 3% or 30 3%. Increased mortality was observed in 634 patients randomizedto a target hematocrit of 42% [221 deaths (35% mortality)] compared to 631 patients targeted to remainat a hematocrit of 30% [185 deaths (29% mortality)]. The reason for the increased mortality observed inthis study is unknown, however, the incidence of non-fatal myocardial infarctions (3.1% vs. 2.3%), vascularaccess thromboses (39% vs. 29%), and all other thrombotic events (22% vs. 18%) were also higher in thegroup randomized to achieve a hematocrit of 42%. An increased incidence of thrombotic events has alsobeen observed in patients with cancer treated with erythropoietic agents.

In a randomized controlled study (referred to as Cancer Study 1 - the BEST study) with another ESA in 939women with metastatic breast cancer receiving chemotherapy, patients received either weekly Epoetin alfaor placebo for up to a year. This study was designed to show that survival was superior when an ESA wasadministered to prevent anemia (maintain hemoglobin levels between 12 and 14 g/dL or hematocritbetween 36% and 42%). The study was terminated prematurely when interim results demonstrated that ahigher mortality at 4 months (8.7% vs. 3.4%) and a higher rate of fatal thrombotic events (1.1% vs. 0.2%)in the first 4 months of the study were observed among patients treated with Epoetin alfa. Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in the Epoetin alfa groupthan in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p = 0.012).

A systematic review of 57 randomized controlled trials (including Cancer Studies 1 and 5 - the BEST andENHANCE studies) evaluating 9353 patients with cancer compared ESAs plus red blood cell transfusionwith red blood cell transfusion alone for prophylaxis or treatment of anemia in cancer patients with orwithout concurrent antineoplastic therapy. An increased relative risk of thromboembolic events (RR 1.67,95% CI: 1.35, 2.06; 35 trials and 6769 patients) was observed in ESA-treated patients. An overall survivalhazard ratio of 1.08 (95% CI: 0.99, 1.18; 42 trials and 8167 patients) was observed in ESA-treated patients.

An increased incidence of deep vein thrombosis (DVT) in patients receiving Epoetin alfa undergoing surgicalorthopedic procedures has been observed (see ADVERSE REACTIONS, Surgery Patients:Thrombotic/Vascular Events in full Prescribing Information). In a randomized controlled study (referred to asthe SPINE study), 681 adult patients, not receiving prophylactic anticoagulation and undergoing spinalsurgery, received either 4 doses of 600 U/kg Epoetin alfa (7, 14, and 21 days before surgery, and the dayof surgery) and standard of care (SOC) treatment, or SOC treatment alone. Preliminary analysis showed ahigher incidence of DVT, determined by either Color Flow Duplex Imaging or by clinical symptoms, in theEpoetin alfa group [16 patients (4.7%)] compared to the SOC group [7 patients (2.1%)]. In addition, 12patients in the Epoetin alfa group and 7 patients in the SOC group had other thrombotic vascular events.Deep venous thrombosis prophylaxis should be strongly considered when ESAs are used for the reductionof allogeneic RBC transfusions in surgical patients (see BOXED WARNINGS and DOSAGE ANDADMINISTRATION in full Prescribing Information).

Increased mortality was also observed in a randomized placebo-controlled study of PROCRIT in adultpatients who were undergoing coronary artery bypass surgery (7 deaths in 126 patients randomized toPROCRIT versus no deaths among 56 patients receiving placebo). Four of these deaths occurred during theperiod of study drug administration and all four deaths were associated with thrombotic events. ESAs are notapproved for reduction of allogeneic red blood cell transfusions in patients scheduled for cardiac surgery.

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence Erythropoiesis-stimulating agents resulted in decreased locoregional control/progression-free survivaland/or overall survival (see Table 1). These findings were observed in studies of patients with advancedhead and neck cancer receiving radiation therapy (Cancer Studies 5 and 6), in patients receivingchemotherapy for metastatic breast cancer (Cancer Study 1) or lymphoid malignancy (Cancer Study 2), andin patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapyor radiotherapy (Cancer Studies 7 and 8).

Table 1: Randomized, Controlled Trials with Decreased Survival and/or Decreased LocoregionalControl

Adverse Achieved Outcome for

Hemoglobin Hemoglobin Primary ESA-containingStudy / Tumor / (n) Target (Median Q1,Q3) Endpoint Arm

Chemotherapy

Cancer Study 1Metastatic breast 12-14 g/dL 12.9 g/dL 12-month overall Decreased 12-monthcancer (n=939) 12.2, 13.3 g/dL survival survival

Cancer Study 2Lymphoid 13-15 g/dL (M) 11.0 g/dL Proportion of Decreased overallmalignancy (n=344) 13-14 g/dL (F) 9.8, 12.1 g/dL patients achieving survival

a hemoglobinresponse

Cancer Study 3Early breast 12.5-13 g/dL 13.1 g/dL Relapse-free and Decreased 3 yr.cancer (n=733) 12.5, 13.7 g/dL overall survival relapse-free and

overall survivalCancer Study 4Cervical Cancer 12-14 g/dL 12.7 g/dL Progression-free Decreased 3 yr.(n=114) 12.1, 13.3 g/dL and overall survival progression-free

and locoregional and overall survivalcontrol and locoregional

control

Radiotherapy Alone

Cancer Study 5Head and neck 15 g/dL (M) Not available Locoregional Decreased 5-yearcancer (n=351) 14 g/dL (F) progression-free locoregional

survival progression-free survival

Decreased overallsurvival

Cancer Study 6Head and neck 14-15.5 g/dL Not available Locoregional Decreasedcancer (n=522) disease control locoregional

disease control

No Chemotherapy or Radiotherapy

Cancer Study 7Non-small cell 12-14 g/dL Not available Quality of life Decreased overalllung cancer (n=70) survival

Cancer Study 8Non-myeloid 12-13 g/dL 10.6 g/dL RBC transfusions Decreased overallmalignancy (n=989) 9.4, 11.8 g/dL survival

Decreased overall survival:Cancer Study 1 (the BEST study) was previously described (see WARNINGS: Increased Mortality, SeriousCardiovascular and Thromboembolic Events). Mortality at 4 months (8.7% vs. 3.4%) was significantly higherin the Epoetin alfa arm. The most common investigator-attributed cause of death within the first 4 monthswas disease progression; 28 of 41 deaths in the Epoetin alfa arm and 13 of 16 deaths in the placebo armwere attributed to disease progression. Investigator assessed time to tumor progression was not differentbetween the two groups. Survival at 12 months was significantly lower in the Epoetin alfa arm (70% vs.76%, HR 1.37, 95% CI: 1.07, 1.75; p = 0.012).

Cancer Study 2 was a Phase 3, double-blind, randomized (darbepoetin alfa vs. placebo) study conducted in344 anemic patients with lymphoid malignancy receiving chemotherapy. With a median follow-up of 29months, overall mortality rates were significantly higher among patients randomized to darbepoetin alfa ascompared to placebo (HR 1.36, 95% CI: 1.02, 1.82).

Cancer Study 7 was a Phase 3, multicenter, randomized (Epoetin alfa vs. placebo), double-blind study, inwhich patients with advanced non-small cell lung cancer receiving only palliative radiotherapy or no activetherapy were treated with Epoetin alfa to achieve and maintain hemoglobin levels between 12 and 14 g/dL.Following an interim analysis of 70 of 300 patients planned, a significant difference in survival in favor of thepatients on the placebo arm of the trial was observed (median survival 63 vs. 129 days; HR 1.84; p = 0.04).

Cancer Study 8 was a Phase 3, double-blind, randomized (darbepoetin alfa vs. placebo), 16-week study in989 anemic patients with active malignant disease, neither receiving nor planning to receive chemotherapyor radiation therapy. There was no evidence of a statistically significant reduction in proportion of patientsreceiving RBC transfusions. The median survival was shorter in the darbepoetin alfa treatment group (8 months) compared with the placebo group (10.8 months); HR 1.30, 95% CI: 1.07, 1.57.

Decreased progression-free survival and overall survival:

Cancer Study 3 (the PREPARE study) was a randomized controlled study in which darbepoetin alfa wasadministered to prevent anemia conducted in 733 women receiving neo-adjuvant breast cancer treatment.After a median follow-up of approximately 3 years, the survival rate (86% vs. 90%, HR 1.42, 95% CI: 0.93,2.18) and relapse-free survival rate (72% vs. 78%, HR 1.33, 95% CI: 0.99, 1.79) were lower in thedarbepoetin alfa-treated arm compared to the control arm.

Cancer Study 4 (protocol GOG 191) was a randomized controlled study that enrolled 114 of a planned 460cervical cancer patients receiving chemotherapy and radiotherapy. Patients were randomized to receiveEpoetin alfa to maintain hemoglobin between 12 and 14 g/dL or to transfusion support as needed.The studywas terminated prematurely due to an increase in thromboembolic events in Epoetin alfa-treated patientscompared to control (19% vs. 9%). Both local recurrence (21% vs. 20%) and distant recurrence (12% vs.7%) were more frequent in Epoetin alfa-treated patients compared to control. Progression-free survival at3 years was lower in the Epoetin alfa-treated group compared to control (59% vs. 62%, HR 1.06, 95% CI:0.58, 1.91). Overall survival at 3 years was lower in the Epoetin alfa-treated group compared to control(61% vs. 71%, HR 1.28, 95% CI: 0.68, 2.42).

Cancer Study 5 (the ENHANCE study) was a randomized controlled study in 351 head and neck cancerpatients where Epoetin beta or placebo was administered to achieve target hemoglobin of 14 and 15 g/dL for women and men, respectively. Locoregional progression-free survival was significantly shorterin patients receiving Epoetin beta (HR 1.62, 95% CI: 1.22, 2.14; p = 0.0008) with a median of 406 daysEpoetin beta vs. 745 days placebo. Overall survival was significantly shorter in patients receiving Epoetinbeta (HR 1.39, 95% CI: 1.05, 1.84; p = 0.02).

Decreased locoregional control:Cancer Study 6 (DAHANCA 10) was conducted in 522 patients with primary squamous cell carcinoma ofthe head and neck receiving radiation therapy randomized to darbepoetin alfa with radiotherapy orradiotherapy alone. An interim analysis on 484 patients demonstrated that locoregional control at 5 yearswas significantly shorter in patients receiving darbepoetin alfa (RR 1.44, 95% CI: 1.06, 1.96; p = 0.02).Overall survival was shorter in patients receiving darbepoetin alfa (RR 1.28, 95% CI: 0.98, 1.68; p = 0.08).

Pure Red Cell AplasiaCases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associatedwith neutralizing antibodies to erythropoietin have been reported in patients treated with PROCRIT. Thishas been reported predominantly in patients with chronic renal failure (CRF) receiving PROCRIT bysubcutaneous administration. Any patient who develops a sudden loss of response to PROCRIT,accompanied by severe anemia and low reticulocyte count, should be evaluated for the etiology of loss ofeffect, including the presence of neutralizing antibodies to erythropoietin (see PRECAUTIONS: Lack or Lossof Response). If anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT and othererythropoietic proteins. Contact ORTHO BIOTECH at 1 888 2ASK OBI (1-888-227-5624) to perform assaysfor binding and neutralizing antibodies. PROCRIT should be permanently discontinued in patients withantibody-mediated anemia. Patients should not be switched to other erythropoietic proteins as antibodiesmay cross-react (see ADVERSE REACTIONS: Immunogenicity).

Albumin (Human)PROCRIT contains albumin, a derivative of human blood. Based on effective donor screening and productmanufacturing processes, it carries an extremely remote risk for transmission of viral diseases.A theoreticalrisk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases oftransmission of viral diseases or CJD have ever been identified for albumin.

PRECAUTIONSThe parenteral administration of any biologic product should be attended by appropriate precautions in caseallergic or other untoward reactions occur (see CONTRAINDICATIONS). In clinical trials, while transientrashes were occasionally observed concurrently with PROCRIT therapy, no serious allergic or anaphylacticreactions were reported (see ADVERSE REACTIONS in full Prescribing Information for more informationregarding allergic reactions).

The safety and efficacy of PROCRIT therapy have not been established in patients with a known history ofa seizure disorder or underlying hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes,or hypercoagulable disorders).

In some female patients, menses have resumed following PROCRIT therapy; the possibility of pregnancyshould be discussed and the need for contraception evaluated.

Hematology: Exacerbation of porphyria has been observed rarely in patients with CRF treated withPROCRIT. However, PROCRIT has not caused increased urinary excretion of porphyrin metabolites innormal volunteers, even in the presence of a rapid erythropoietic response. Nevertheless, PROCRIT shouldbe used with caution in patients with known porphyria.

In preclinical studies in dogs and rats, but not in monkeys, PROCRIT therapy was associated withsubclinical bone marrow fibrosis. Bone marrow fibrosis is a known complication of CRF in humans and maybe related to secondary hyperparathyroidism or unknown factors. The incidence of bone marrow fibrosiswas not increased in a study of adult patients on dialysis who were treated with PROCRIT for 12 to 19months, compared to the incidence of bone marrow fibrosis in a matched group of patients who had notbeen treated with PROCRIT.

Cancer patients should have hemoglobin measured once a week until hemoglobin has been stabilized, andmeasured periodically thereafter.

Lack or Loss of Response: If the patient fails to respond or to maintain a response to doses within therecommended dosing range, the following etiologies should be considered and evaluated: 1. Iron deficiency:Virtually all patients will eventually require supplemental iron therapy (see IRON EVALUATION); 2. Underlyinginfectious, inflammatory, or malignant processes; 3. Occult blood loss; 4. Underlying hematologic diseases (ie, thalassemia, refractory anemia, or other myelodysplastic disorders); 5. Vitamin deficiencies: Folic acidor vitamin B12; 6. Hemolysis; 7. Aluminum intoxication; 8. Osteitis fibrosa cystica; 9. Pure Red Cell Aplasia(PRCA) or anti-erythropoietin antibody-associated anemia: In the absence of another etiology, the patientshould be evaluated for evidence of PRCA and sera should be tested for the presence of antibodies toerythropoietin (see WARNINGS: Pure Red Cell Aplasia).

Iron Evaluation: During PROCRIT therapy, absolute or functional iron deficiency may develop. Functionaliron deficiency, with normal ferritin levels but low transferrin saturation, is presumably due to the inabilityto mobilize iron stores rapidly enough to support increased erythropoiesis. Transferrin saturation should beat least 20% and ferritin should be at least 100 ng/mL.

Prior to and during PROCRIT therapy, the patients iron status, including transferrin saturation (serum irondivided by iron binding capacity) and serum ferritin, should be evaluated. Virtually all patients will eventuallyrequire supplemental iron to increase or maintain transferrin saturation to levels which will adequatelysupport erythropoiesis stimulated by PROCRIT.

Drug Interaction: No evidence of interaction of PROCRIT with other drugs was observed in the course ofclinical trials.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenic potential of PROCRIT has notbeen evaluated. PROCRIT does not induce bacterial gene mutation (Ames Test), chromosomal aberrationsin mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus. In female rats treated IVwith PROCRIT, there was a trend for slightly increased fetal wastage at doses of 100 and 500 Units/kg.

Pregnancy Category C: PROCRIT has been shown to have adverse effects in rats when given in doses 5 times the human dose. There are no adequate and well-controlled studies in pregnant women. PROCRIT

should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

In studies in female rats, there were decreases in body weight gain, delays in appearance of abdominal hair,delayed eyelid opening, delayed ossification, and decreases in the number of caudal vertebrae in the F1fetuses of the 500 Units/kg group. In female rats treated IV, there was a trend for slightly increased fetalwastage at doses of 100 and 500 Units/kg. PROCRIT has not shown any adverse effect at doses as highas 500 Units/kg in pregnant rabbits (from day 6 to 18 of gestation).

Nursing Mothers: Postnatal observations of the live offspring (F1 generation) of female rats treated withPROCRIT during gestation and lactation revealed no effect of PROCRIT at doses of up to 500 Units/kg.There were, however, decreases in body weight gain, delays in appearance of abdominal hair, eyelidopening, and decreases in the number of caudal vertebrae in the F1 fetuses of the 500 Units/kg group.There were no PROCRIT-related effects on the F2 generation fetuses.

It is not known whether PROCRIT is excreted in human milk. Because many drugs are excreted in humanmilk, caution should be exercised when PROCRIT is administered to a nursing woman.

Pediatric Use: See WARNINGS: Pediatrics

Pediatric Cancer Patients on Chemotherapy: The safety and effectiveness of PROCRIT were evaluated ina randomized, double-blind, placebo-controlled, multicenter study (see CLINICAL EXPERIENCE, Weekly (QW)Dosing, Pediatric Patients in full Prescribing Information).

Geriatric Use: Insufficient numbers of patients age 65 or older were enrolled in clinical studies of PROCRIT

for the treatment of anemia associated with pre-dialysis chronic renal failure, cancer chemotherapy, andZidovudine-treatment of HIV infection to determine whether they respond differently from younger subjects.

Information for PatientsPatients should be informed of the increased risks of mortality, serious cardiovascular events,thromboembolic events, and increased risk of tumor progression or recurrence (see WARNINGS). In thosesituations in which the physician determines that a patient or their caregiver can safely and effectivelyadminister PROCRIT at home, instruction as to the proper dosage and administration should be provided.Patients should be instructed to read the PROCRIT Medication Guide and Patient Instructions for Use andshould be informed that the Medication Guide is not a disclosure of all possible side effects. Patients shouldbe informed of the possible side effects of PROCRIT and of the signs and symptoms of allergic drugreaction and advised of appropriate actions. If home use is prescribed for a patient, the patient should bethoroughly instructed in the importance of proper disposal and cautioned against the reuse of needles,syringes, or drug product. A puncture-resistant container should be available for the disposal of usedsyringes and needles, and guidance provided on disposal of the full container.

Hypertension: Hypertension, associated with a significant increase in hemoglobin, has been noted rarelyin patients treated with PROCRIT. Nevertheless, blood pressure in patients treated with PROCRIT

should be monitored carefully, particularly in patients with an underlying history of hypertension orcardiovascular disease.

Seizures: In double-blind, placebo-controlled trials, 3.2% (n = 2/63) of patients treated with PROCRIT TIWand 2.9% (n = 2/68) of placebo-treated patients had seizures. Seizures in 1.6% (n = 1/63) of patientstreated with PROCRIT TIW occurred in the context of a significant increase in blood pressure andhematocrit from baseline values. However, both patients treated with PROCRIT also had underlying CNSpathology which may have been related to seizure activity.

In a placebo-controlled, double-blind trial utilizing weekly dosing with PROCRIT, 1.2% (n = 2/168) ofsafety-evaluable patients treated with PROCRIT and 1% (n = 1/165) of placebo-treated patients hadseizures. Seizures in the patients treated with weekly PROCRIT occurred in the context of a significantincrease in hemoglobin from baseline values however significant increases in blood pressure were notseen. These patients may have had other CNS pathology.

Thrombotic Events: In double-blind, placebo-controlled trials, 3.2% (n = 2/63) of patients treated withPROCRIT TIW and 11.8% (n = 8/68) of placebo-treated patients had thrombotic events (eg, pulmonaryembolism, cerebrovascular accident), (see WARNINGS: Increased Mortality, Serious Cardiovascular andThromboembolic Events).

In a placebo-controlled, double-blind trial utilizing weekly dosing with PROCRIT, 6.0% (n = 10/168) ofsafety-evaluable patients treated with PROCRIT and 3.6% (n = 6/165) (p = 0.444) of placebo-treatedpatients had clinically significant thrombotic events (deep vein thrombosis requiring anticoagulant therapy,embolic event including pulmonary embolism, myocardial infarction, cerebral ischemia, left ventricularfailure and thrombotic microangiopathy). A definitive relationship between the rate of hemoglobin increaseand the occurrence of clinically significant thrombotic events could not be evaluated due to the limitedschedule of hemoglobin measurements in this study.

The safety and efficacy of PROCRIT were evaluated in a randomized, double-blind, placebo-controlled,multicenter study that enrolled 222 anemic patients ages 5 to 18 receiving treatment for a variety ofchildhood malignancies. Due to the study design (small sample size and the heterogeneity of the underlyingmalignancies and of anti-neoplastic treatments employed), a determination of the effect of PROCRIT onthe incidence of thrombotic events could not be performed. In the PROCRIT arm, the overall incidence ofthrombotic events was 10.8% and the incidence of serious or life-threatening events was 7.2%.

ADVERSE REACTIONSImmunogenicityAs with all therapeutic proteins, there is the potential for immunogenicity. Neutralizing antibodies toerythropoietin, in association with PRCA or severe anemia (with or without other cytopenias), have beenreported in patients receiving PROCRIT (see WARNINGS: Pure Red Cell Aplasia) during post-marketingexperience.

There has been no systematic assessment of immune responses, i.e., the incidence of either binding orneutralizing antibodies to PROCRIT, in controlled clinical trials.

Where reported, the incidence of antibody formation is highly dependent on the sensitivity and specificityof the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity inan assay may be influenced by several factors including assay methodology, sample handling, timing ofsample collection, concomitant medications, and underlying disease. For these reasons, comparison of theincidence of antibodies across products within this class (erythropoietic proteins) may be misleading.

Adverse Experiences Reported in Clinical TrialsIn double-blind, placebo-controlled studies of up to 3 months duration involving 131 cancer patients,adverse events with an incidence > 10% in either patients treated with PROCRIT or placebo-treatedpatients were as indicated below:

Percent of Patients Reporting Event

Patients Treated Placebo-treatedWith PROCRIT Patients

Event (n = 63) (n = 68)

Pyrexia 29% 19%Diarrhea 21%* 7%Nausea 17%* 32%Vomiting 17% 15%Edema 17%* 1%Asthenia 13% 16%Fatigue 13% 15%Shortness of Breath 13% 9%Parasthesia 11% 6%Upper Respiratory Infection 11% 4%Dizziness 5% 12%Trunk Pain 3%* 16%

* Statistically significant

Although some statistically significant differences between patients being treated with PROCRIT andplacebo-treated patients were noted, the overall safety profile of PROCRIT appeared to be consistent with thedisease process of advanced cancer. During double-blind and subsequent open-label therapy in whichpatients (n = 72 for total exposure to PROCRIT) were treated for up to 32 weeks with doses as high as 927Units/kg, the adverse experience profile of PROCRIT was consistent with the progression of advanced cancer.

Three hundred thirty-three (333) cancer patients enrolled in a placebo-controlled double-blind trial utilizingWeekly dosing with PROCRIT for up to 4 months were evaluable for adverse events. The incidence ofadverse events was similar in both the treatment and placebo arms.

OVERDOSAGEThe expected manifestations of PROCRIT overdosage include signs and symptoms associated with anexcessive and/or rapid increase in hemoglobin concentration, including any of the cardiovascular eventsdescribed in WARNINGS and listed in ADVERSE REACTIONS in full Prescribing Information. Patients receivingan overdosage of PROCRIT should be monitored closely for cardiovascular events and hematologicabnormalities. Polycythemia should be managed acutely with phlebotomy, as clinically indicated. Followingresolution of the effects due to PROCRIT overdosage, reintroduction of PROCRIT therapy should beaccompanied by close monitoring for evidence of rapid increases in hemoglobin concentration (>1 gm/dLper 14 days). In patients with an excessive hematopoietic response, reduce the PROCRIT dose inaccordance with the recommendations described in DOSAGE AND ADMINISTRATION in full PrescribingInformation.

DOSAGE AND ADMINISTRATIONIMPORTANT: See BOXED WARNINGS and WARNINGS: Increased Mortality, Serious Cardiovascularand Thromboembolic Events.

Prior to initiating treatment with PROCRIT a hemoglobin should be obtained to establish that it is >10 to13 g/dL. The recommended dose of PROCRIT is 300 Units/kg/day subcutaneously for 10 days beforesurgery, on the day of surgery, and for 4 days after surgery.

An alternate dose schedule is 600 Units/kg PROCRIT subcutaneously in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

All patients should receive adequate iron supplementation. Iron supplementation should be initiated no laterthan the beginning of treatment with PROCRIT and should continue throughout the course of therapy. Deep venous thrombosis prophylaxis should be strongly considered (see BOXED WARNINGS).

PREPARATION AND ADMINISTRATION OF PROCRIT

1. Do not shake. It is not necessary to shake PROCRIT. Prolonged vigorous shaking may denature anyglycoprotein, rendering it biologically inactive.

2. Protect the solution from light. Parenteral drug products should be inspected visually for particulatematter and discoloration prior to administration. Do not use any vials exhibiting particulate matter ordiscoloration.

3. Using aseptic techniques, attach a sterile needle to a sterile syringe. Remove the flip top from the vialcontaining PROCRIT, and wipe the septum with a disinfectant. Insert the needle into the vial, andwithdraw into the syringe an appropriate volume of solution.

4. Single-dose: 1 mL vial contains no preservative. Use one dose per vial; do not re-enter the vial.Discard unused portions.

Multidose: 1 mL and 2 mL vials contain preservative. Store at 2 to 8C after initial entry and betweendoses. Discard 21 days after initial entry.

5. Do not dilute or administer in conjunction with other drug solutions. However, at the time of SCadministration, preservative-free PROCRIT from single-use vials may be admixed in a syringe withbacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) ata 1:1 ratio using aseptic technique. The benzyl alcohol in the bacteriostatic saline acts as a localanesthetic which may ameliorate SC injection site discomfort. Admixing is not necessary when usingthe multidose vials of PROCRIT containing benzyl alcohol.

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLICEVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Renal failure: Patients experienced greater risks for death and serious cardiovascular eventswhen administered erythropoiesis-stimulating agents (ESAs) to target higher versus lowerhemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualizedosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression orrecurrence in some clinical studies in patients with breast, non-small cell lung, head andneck, lymphoid, and cervical cancers (see WARNINGS: Table 1).

To decrease these risks, as well as the risk of serious cardio- and thrombovascularevents, use the lowest dose needed to avoid red blood cell transfusion.

Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.

ESAs are not indicated for patients receiving myelosuppressive therapy when theanticipated outcome is cure.

Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients notreceiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events,WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence,INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION in full Prescribing Information.)

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799

Distributed by:Ortho Biotech Products, L.P.Raritan, New Jersey 08869-0670

Revised 08/2008 OBPLP 2000 10112802BC

December 2008 GREEN HILL HEALTHCARE COMMUNICATIONS 9

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which includes two hospitals, onemammography clinic, a regional can-cer center, four surgical offices, and avariety of community resources. LaurieMathis, RN, came on board to help in2003. Gentry is at the helm of thisemerging field locally and speaksnationally to other healthcare organi-zations on this concept.

Where does the nurse navigatorconcept come from?

The concept of patient navigationor nurse navigation began in the1990s when Dr Harold P. Freemanestablished the first program at Harlem[New York] Hospital Center afterobserving that many cancer patientsdid not return for follow-up care. Hewanted to improve access to cancerscreening and address the barriers tocancer care that residents of Harlemencountered. The pilot navigation pro-gram compared 5-year survival rates ofbreast cancer patients who were andwere not navigated through the sys-tem by a social worker, and it demon-strated a survival advantage amongpatients with navigators.1

Word of his program and its success-es spread, and the idea caught fire withthe publication of the 2001 PresidentsCancer Panel report, Voices for aBroken System.2 The report identifiedmajor barriers to cancer care encom-passing all socioeconomic levels, andrecommended patient navigation pro-grams as part of the solution. In 2005,President Bush signed the PatientNavigator Outreach and Chronic Dis-ease Prevention Act, which providedfunds for navigation programs withinUS cancer centers. The concept nowappears to be growing rapidly.

Is there a regional or nationalnetwork or organization for nursenavigators?

Nationally, there is a focus group thatmeets at the Oncology Nursing Societysannual congress (www.ons.org) and isled by Cynthia Cantril, RN, MPH, fromForest Knolls, Calif. Any OncologyNursing Society member is eligible tojoin this networking group. There isanother national group called theNational Coalition of Oncology NurseNavigators that has a mission to pro-mote excellence in oncology patientcare by fostering collaborative relation-ships and professional developmentamong oncology nurse navigators andother healthcare disciplines. This group(www.nconn.org) is led by TinaBeerman, RN, BS, from Columbia, Md.Both of these organizations have a focuson nurses as the navigators.

In North Carolina, we have formedthe North Carolina Oncology NavigatorAssociation, which brings together navi-gators (nurses, social workers, lay navi-gators) who work with a variety of cancers to promote quality patientnavigation and serves as a network fornavigators in North Carolina. We workunder the vision and mission of theNorth Carolina State Cancer Plan(www.NCCancer.com).

How did your own programbegin?

Our navigator program started in2001 and was driven by breast cancerpatients. Newly diagnosed breast can-cer patients voiced concern that theywere overwhelmed with informationand choices. With focus groups, it wasdetermined that there was a need for acentral source of information and forimprovement in the flow of breast careacross the local healthcare system. Theconcept of patient navigation wasexplored, and the directors of the localbreast imaging center and cancer cen-ter decided that a nurse would be thebest fit for this venture. I had recentlycompleted a masters degree program innursing education and I had a back-ground in oncology and genetics in thehigh-risk clinic. Since I was familiarwith cancer care and resources in thecommunity and was already workingwithin the healthcare system, I wasoffered the challenge to navigate thebreast cancer patients.

Are certain background experiences, qualifications,degrees, or certificationsrequired to be a nurse navigator?

At this time, there is no national stan-dard of care or certification for naviga-tion. In February 2009, the OncologyNursing Society will offer a test for theCertified Breast Care Nurse (www.oncc.org), which is aimed at testing theknowledge necessary for a nurse to prac-tice breast care competently. This certifi-cation will be a validation of an individ-uals knowledge of breast care. At the19th Annual National InterdisciplinaryBreast Center Conference in 2009, therewill be a 1-day Breast Health NavigatorCertification Course with a certificationexam the next morning (www.breastcare.org). The purpose is to validate thehealthcare professionals knowledge toperform as a breast health patient educa-tor or navigator. Each healthcare systemneeds to evaluate what is needed to unifycare in their system.

From a personal viewpoint, to becomea nurse navigator, it helps to be anemployee of that particular healthcaresystem so you will know the staff, knowhow to access medical information, andbe willing to share with the administra-tion consistent patient concerns abouttheir care.

What was your first step inimplementing the nurse navigatorprogram?

My aim was to improve the flow ofbreast care for all of our patients. It tookme 18 months to put the program inplace. I began by spending the first yearat the breast clinic, observing howpatients enter the systemwhere theycome in, where they go next. Some comefrom the breast clinic, but others comefrom surgical offices and even emer-gency departments. You start by gain-ing a perspective on the whole system,understanding the process of care

within it, and identifying resourcesyou can tap into within the largercommunity.

What obstacles might one facein implementing a navigationprogram?

Gaining support for the idea of nav-igation is most important. You needthe cooperation of leaders who willchampion your cause. This would bethe director of the cancer center, direc-tor of the imaging center, hospitalchief executive officer, chief operatingofficers, and so forth. These peopleneed to be on board and to understandyour goals and time frame. Our onlyopposition came from a few surgeonswho said they didnt see the need forit. After it was shown that navigationdid not challenge their role or the carethey wanted their patients to receive,they gave their full support. Physiciansnotice that less time is needed for con-sultation when patients are educatedand prepared for their visit with perti-nent questions. That is a payoff fordoctors as well as patients. In additionto getting full cooperation, anotherobstacle to starting a navigation pro-gram is lack of time. Our navigatorsare on call for the patients 24 hours aday. That concept works in our systembut may not be feasible in otherhealthcare systems.

Is the job description of nurse navigator universal or customized to different practice settings?

You have to customize the job to the

healthcare system. For example, in oursystem, we considered using someonebesides a nurse and it did not work out.We felt a nurse can look at the patientholistically, can understand the health-care system, and can offer a clinical back-ground. In other systems, social workersmay have better connections to re-sources within the community.

Our program is community-based andwe link together the breast imaging clin-ic, cancer center, hospitals, surgicaloffices, and community resources. Insome other systems, the navigator maybe confined to the breast clinic as abreast health educator or breast healthimaging educator and may follow thepatient only through his or her diagnos-tic biopsy. I follow patients through allaspects of care, beginning with diagnosisand through the treatment phase, even ifit includes radiation, chemotherapy,and/or hormonal therapy.

What services do you provide thepatient with breast cancer?

As soon as I am notified that thepatient has received a diagnosis ofbreast cancer, I pick up the phone or goto the physicians office to meet withher. I explain my role and say, Letstalk about what the doctor just toldyou. Sometimes I need to redirect thepatient on what she has heard or notheard. For example, one patient toldme right after her diagnosis, I ammaking out my will. But because I hadher pathology report, I knew she had avery early form of breast cancer that

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Navigating the JourneyContinued from cover

iStockphoto.com/Annett Vauteck

10 GREEN HILL HEALTHCARE COMMUNICATIONS December 2008

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was highly curable. It was very rewardingfor me to be able to tell her what shecould expect. Right up front, I can makea difference by clarifying a patients con-dition for her. I can educate the patient,This is what you have and these areyour next steps. My aim is to empowerthe patient and help her feel in control.

During the first phone call or visit, Ialso try to learn about the patients fami-ly situation. Does she have a spouse, chil-dren, insurance? I can help the patienttell her children about the cancer andrefer her to other resources and patientassistance programs.

When a patient does not respond totreatment or has a recurrence, emphasisis placed on continued care, whether it isfor more treatment or hospice care. I donot make decisions for the patient. I giveinformation and support her in whateverdecision she makes. Also, I do not wantto duplicate the services of others (forexample, hospice).

I listen to patients, hear their frustra-tions or complaints as they go throughtreatment, and take these concerns tothe cancer center administration orbreast care team. For example, patientswere frustrated that on the day of theirsurgery, they had to make two stopsbefore they checked in for surgery. After

discussion with the cancer center com-mittee, changes were made over time toeliminate one stop. This streamlined theflow and made patients happier. Withfeedback from patients, we develop astronger breast cancer care program. Weidentify barriers and ask physicians andadministration to recognize them andsolve them as a team.

Are you involved in decision-making regarding treatment?

I am to some extent through theweekly tumor board, which is run byour nurse navigation team and thebreast medical oncologist. When apatient is presented, the nurse naviga-tor may add social factors. Forinstance, the patient may be a singlemother with no short- or long-termdisability insurance who must keepher insurance and therefore mustremain employed. This information isshared so the doctors can see thewhole picture.

How is your program funded?Can you show a financial valuefor the services of a nurse navigator?

My salary and benefits are financedthrough our cancer center. The center

funds two full-time breast navigators, twopart-time thoracic navigators, a full-timecolon navigator, a full-time care coordi-nator, who is a nurse with a social workbackground, and an administrative assis-tant. We can show a return on invest