Patient Navigation in Breast Cancer Treatment and ... · patient navigation in improving treatment and survivorship outcomes in women with breast cancer. Methods The review included

JOURNAL OF CLINICAL ONCOLOGY R E V I E W A R T I C L E

All authors: San Diego State University/

University of California San Diego Joint

Doctoral Program in Clinical Psychology;

Linda C. Gallo and Kristen J. Wells, San

Diego State University; and Sharon H.

Baik and Kristen J. Wells, University of

California San Diego Moores Cancer

Center, San Diego, CA.

Published online ahead of print at

www.jco.org on July 25, 2016.

Supported by the National Cancer

Institute at the National Institutes of

Health (Grant No. R21CA161077 to

K.J.W.).

The content is solely the responsibility of

the authors and does not necessarily

represent the official views of the National

Institutes of Health.

Authors’ disclosures of potential conflicts

of interest are found in the article online at

www.jco.org. Author contributions are

found at the end of this article.

Corresponding author: Kristen J. Wells,

PhD, Department of Psychology, San

Diego State University, 6363 Alvarado Ct,

Ste 103, San Diego, CA 92120-4913;

e-mail: [email protected].

© 2016 by American Society of Clinical

Oncology

0732-183X/16/3430w-3686w/$20.00

DOI: 10.1200/JCO.2016.67.5454

Patient Navigation in Breast Cancer Treatment andSurvivorship: A Systematic ReviewSharon H. Baik, Linda C. Gallo, and Kristen J. Wells

A B S T R A C T

PurposePatient navigation is an intervention approach that improves cancer outcomes by reducing barriersand facilitating timely access to cancer care. Little is known about the benefits of patient navigationduring breast cancer treatment and survivorship. This systematic review evaluates the efficacy ofpatient navigation in improving treatment and survivorship outcomes in women with breast cancer.

MethodsThe review included experimental and quasi-experimental studies of patient navigation programsthat target breast cancer treatment and breast cancer survivorship. Articles were systematicallyobtained through electronic database searches of PubMed/MEDLINE, PsycINFO, Web of Science,CINAHL, and Cochrane Library. The Effective Public Health Practice Project Quality AssessmentTool was used to evaluate the methodologic quality of individual studies.

ResultsThirteen studies met the inclusion criteria. Most were of moderate to high quality. Outcomestargeted included timeliness of treatment initiation, adherence to cancer treatment, and adherenceto post-treatment surveillance mammography. Heterogeneity of outcome assessments precludeda meta-analysis. Overall, results demonstrated that patient navigation increases surveillancemammography rates, but only minimal evidence was found with regard to its effectiveness inimproving breast cancer treatment outcomes.

ConclusionThis study is the most comprehensive systematic review of patient navigation research focused onimproving breast cancer treatment and survivorship. Minimal research has indicated that patientnavigation may be effective for post-treatment surveillance; however, more studies are neededto draw definitive conclusions about the efficacy of patient navigation during and after cancertreatment.

J Clin Oncol 34:3686-3696. © 2016 by American Society of Clinical Oncology

INTRODUCTION

Despite advancements in cancer screening, earlydetection, and cancer treatments, significant racial/ethnic and socioeconomic disparities in canceroutcomes still remain.1,2 These disparities are partlydue to unequal access to timely, high-quality cancercare among racially diverse and lower socioeco-nomic status populations.3-5 Delays in breast cancerdiagnosis and treatment are associated with largertumors, late-stage diagnosis, lower cure rates,disease progression, poorer prognosis, andshorter survival.6,7

Patient navigation is a potential strategy toreduce cancer-related disparities and improveoutcomes by eliminating barriers to obtaining

quality cancer care. Patient navigation refers tothe individualized assistance provided to patientsthrough the cancer care continuum to navigatethe complex health care system.8 As an interventionmodel, patient navigation generally provides assis-tance to individual patients for a defined episode ofcancer-related care, targets a defined set of healthservices to complete a specific cancer care goal, hasa defined end point in which service delivery iscomplete, focuses on identifying and resolvingbarriers to receiving care, and aims to reducedelays in accessing services throughout the con-tinuum of cancer care.9 Cancer-related patientnavigation programs vary widely in terms of thepersonnel and services provided.9,10 Patient navi-gators may be health care professionals (eg, nurses,social workers) or lay/community health workers

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(eg, peer supporters, cancer survivors) with various educationalbackgrounds and training.10 Depending on the needs of patients,barriers identified, and targeted cancer care goals, navigators providea wide range of support, including emotional, logistical/practical,and informational.11

Previous reviews of patient navigation in cancer care havesuggested that patient navigation is effective in improving cancerscreening rates, adherence to follow-up care after abnormal results,and timeliness of diagnostic resolution, whereas evidence of patientnavigation reducing late-stage cancer diagnosis or improvingcancer treatment outcomes is limited or inconclusive.9,10,12 Thesereviews, however, lack methodologic rigor in that they did notinvolve a comprehensive search of the literature. They used onlya single biomedical database (PubMed)9,10,12 or an additionalsimilar database (Ovid)12 to locate studies, which restricted theidentification of relevant articles from other databases. In addition,these reviews did not examine the methodologic quality of includedstudies. Despite the proliferation of research in patient navigation,efficacy studies of patient navigation to improve breast cancer carehave not been reviewed since 2011,10 and no systematic review hasevaluated the use of patient navigation during breast cancer treatmentand survivorship. We therefore conducted a comprehensive sys-tematic review of intervention studies that assessed the efficacy ofpatient navigation in improving outcomes related to breast cancertreatment and survivorship. The purpose of this systematic reviewwas to identify patient navigation programs that target breast cancertreatment and survivorship, evaluate the efficacy of patient navigationon cancer treatment and survivorship outcomes compared with usualcare in women with breast cancer, and critically examine and syn-thesize the cumulative evidence on the effectiveness of patient nav-igation in improving breast cancer treatment and survivorship care.

METHODS

Search StrategyThe search was limited to articles that were published after 1990,

which was the year the first patient navigation program was implementedin the United States.13 PubMed/MEDLINE, PsycINFO, Web of Science,CINAHL, and Cochrane Library databases were systematically searchedfrom 1990 to March 2015 by using prespecified Medical Subject Headings(MeSH) terms and keywords to identify patient navigation interventions toimprove breast cancer treatment and survivorship outcomes. Combina-tions of terms associated with breast cancer, patient navigation, cancertreatment, and cancer survivorship were used. The final search strategyused for PubMed/MEDLINE (Table 1) was adapted for each electronicdatabase. Reference lists and keyword searches from eligible articles werealso reviewed to identify additional publications.

Study SelectionCitations from all search results were downloaded and merged by

using a reference management software package (EndNote X7.3.1;Thomson Reuters, Philadelphia, PA). One author (S.H.B.) screened studytitles and abstracts for potential inclusion and then reviewed full-textarticles, including reference lists, to determine their eligibility. Studies wereeligible for inclusion if they were written in English, conducted in theUnited States, evaluated a patient navigation intervention for patients withbreast cancer during treatment and/or survivorship, and empirically ex-amined treatment and/or survivorship outcomes. For the purpose of thisreview, patient navigation was defined as an intervention that reduces

barriers to care and targets a particular cancer care goal. For the purpose ofevaluating cancer care outcomes post-treatment, cancer survivorship wasdefined as the period that follows completion of primary cancer treatmentup to end of life.14

Study designs eligible for inclusion were experimental or quasi-experimental studies (eg, randomized controlled trials [RCTs], non-randomized trials) that included an intervention group that receivedpatient navigation and a control group (eg, usual care) for comparison.Study participants were restricted to women with breast cancer who wereprescribed to begin, were undergoing, or had completedmedical treatmentfor breast cancer. Studies were limited to those conducted in the UnitedStates due to substantial differences in health care systems among countries,including other English-speaking countries (eg, Canada, United Kingdom).Studies without a comparison group or without quantitative analyses werealso excluded. Studies were not excluded if patient navigation was combinedwith another intervention or if either intervention or comparison groupincluded patients with another cancer type on the condition that analyseswere conducted separately for patients with breast cancer. Review articles,published abstracts, conference proceedings, intervention manuals, andunpublished studies were excluded.

Data ExtractionA standardized spreadsheet was used to extract data on study setting

and design, intervention characteristics (description of patient navigationintervention and/or navigator, intervention, and control group details),sample characteristics (sample size, age, race/ethnicity, primary language,and health insurance status), outcomes related to cancer treatment andsurvivorship, and quantitative assessment of targeted outcomes. Hetero-geneity in outcome definitions and assessments did not permit the poolingof outcomes or a meta-analysis. The quality of evidence for each study wasexamined by using the Effective Public Health Practice Project QualityAssessment Tool for Quantitative Studies,15 which evaluates selection bias,study design, confounders, blinding of study participants and assessors,data collection methods, and withdrawals and dropouts. The strength ofeach component and global ratings ranged from weak to strong.

RESULTS

Figure 1 illustrates the study identification, screening, eligibility,and selection process. Nine hundred eighty-seven articles wereidentified through five database searches, and an additional 11

Table 1. PubMed/MEDLINE Search Strategy

1 “Breast neoplasms” [MeSH] OR “breast neoplasm” OR“breast cancer” OR (breast cancer)

2 “Patient navigation” [MeSH] OR “patient navigation” ORnavigation OR navigator OR (patient navigat*) OR (cancernavigat*) OR (nurse navigat*) OR (clinical navigat*) OR (clientnavigat*) OR (system navigat*) OR (professional navigat*)

3 “Breast neoplasms/therapy” [MeSH] OR “breast neoplasms/drug therapy” [MeSH] OR “breast neoplasms/radiotherapy”[MeSH] OR “breast neoplasms/surgery” [MeSH] OR“mastectomy” [MeSH] OR “estrogen receptor modulators”[MeSH] OR “combined modality therapy” [MeSH] OR“antineoplastic agents” [MeSH] OR (cancer treatment) OR(cancer therapy) OR chemotherapy OR “radiotherapy”[MeSH] OR “survivors” [MeSH] OR surviv* OR surveillanceOR “mammography” [MeSH] OR mammogram OR “posttreatment” OR “follow-up care” OR “follow-up treatment”OR “follow-up therapy” OR “long-term care”OR “long-termtreatment” OR “long-term therapy” OR “survivorship care”

4 1 AND 2 AND 3

Abbreviation: MeSH, Medical Subject Headings.

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Breast Cancer Navigation in Treatment and Survivorship


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articles were identified from backward and forward searches. Afterremoving duplicate publications, 536 titles and abstracts werescreened for eligibility, and 509 articles were excluded for notmeeting inclusion criteria. After full-text review, 14 additionalarticles were excluded. Thirteen peer-reviewed studies were eligiblefor inclusion in the synthesis. Descriptions and results from theincluded studies are presented in Table 2.

Quality of EvidenceTable 3 summarizes the methodologic quality assessment used

in this review. Nearly one half of the studies received moderateglobal quality ratings, as a result of weak ratings on withdrawalsand dropouts (eg, did not report the number of participants whowithdrew, dropped out, or completed the study),17,23,27 con-founders (eg, control of confounders not described),18,25 andselection bias (eg, , 60% of eligible patients agreed to participatein study).16 Five studies received strong global ratings,20-22,24,28 andthe remaining two studies received weak global ratings due to weakscores on study design,26 confounders,19 and withdrawals anddropouts.19 Overall, the quality rating for the 13 reviewed studieswas moderate. Two of the included studies18,23 were part of the

Patient Navigation Research Program (PNRP), a nine-site clinical trialto evaluate the efficacy and cost-effectiveness of patient navigation.29

Although the studies assessed different outcomes, one combined dataacross sites,23 which may have included the other study’s sample.18

Furthermore, three studies19-21 were conducted by the same group ofresearchers, used the same or similar intervention (Screening Ad-herence Follow-Up program), and had similar study samples becauseparticipants may have been recruited from the same sites.

Study CharacteristicsOf the 13 studies, three were RCTs,16,20,21 one was a multi-

center quasi-experimental study with various study designs thatincluded RCTs and nonrandomized trials,23 one was a single-groupstudy,26 four were prospective cohort studies,18,19,24,27 and fourwere retrospective cohort studies.17,22,25,28 The control groupscomprised patients with breast cancer who received usual care orusual care plus written informational materials. In the single-groupstudy, patients from National Comprehensive Cancer Network(NCCN) centers served as the comparison group, and concordancedata from NCCN institutions were used as a benchmark fornavigated patients. Patient navigation programs were primarily

Records identified through database search(n = 987)

Scr

een

ing

Incl

ud

edE

ligib

ility

Iden

tifi

cati

on

Records after duplicates removed(n = 536)

Titles/abstracts screened

Records excluded(n = 509)

Conference abstracts/not full article (n = 12)Not patient navigation (n = 287)Not United States (n = 15)Focus not breast cancer (n = 56)Not intervention study (n = 78)Not treatment or survivorship outcomes (n = 61)

Full-text articles assessed for eligibility

(n = 27) Full-text articles excluded, with reasons

(n = 14)

Focus not breast cancer (n = 7)Not intervention study (n = 2)No comparison group (n = 1)Not treatment or survivorship outcomes (n = 4)

Studies included inqualitative synthesis

(n = 13)

Records identified in

PubMed (n = 441)

Recordsidentified in

Web of Science (n = 365)


PsycINFO (n = 55)


CINAHL (n = 83)


Cochrane (n = 43)

Additional records identified through

other sources(n = 11)

Fig 1. Diagram of study identificationand selection process.

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Baik et al


Table 2. Summary of PNPs for Breast Cancer Treatment and Survivorship Care

First AuthorStudy Design and

Setting Intervention Sample Characteristics Outcome Measures Results

Bickell16 RCT; participantsrandomly assigned tousual care (CON;written materials) orintervention (INT; PNP)

Eight inner-city hospitals(New York, NY)

PNP included an individualizedaction plan on the basis ofneeds assessment for patientassistance programs related tobreast cancer and treatment.

PNs were trained in identifyingand addressing barriers to careand provided casemanagement andinformational, emotional, andpractical support.

N 5 374Mean age:56.7 years(SD, 12 years)

Race/ethnicity:White (44.8%)Hispanic (30.3%)Black (20.1%)Asian (4%)Other (0.8%)

Health insurance:Private (56%)Medicaid (23.9%)Medicare (18.2%)Uninsured (1.9%)

Adjuvant treatmentadherence rates forreceipt of RT, CT, andHT

No statistically significantdifferences in adherence ratesto adjuvant treatments betweenINT and CON were found. Bothgroups had high rates of RT(87% v 91%; P 5 .39), CT (93%v 86%; P 5 .42), and HT (92% v93%; P 5 .80)

Chen17 Retrospective cohortstudy; comparison ofpatients who receivedcare before (CON) andafter (INT)implementation ofa breast cancer PNP

Public hospital (LosAngeles County, CA)

PNs were bilingual (English,Spanish) and bicultural; weretrained in medicalinterpretation, culturalcompetency, casemanagement, and patientnavigation; and providedcommunity outreach, healtheducation, psychosocialsupport, care coordination,and access to transportationand financial resources.

N 5 100Median age at diagnosis:54 years (range, 30-82years)

Race/ethnicity:Hispanic/Latina (51%)

Primary language:Spanish (57%)

Health insurance:Uninsured (100%)

Treatment adherencerates for receipt of RT,CT, and HT

Adherence topost-treatmentsurveillancemammography

No statistically significantdifferences were found intreatment adherence ratesbetween INT and CON.

After implementation of PNP,adherence to surveillancemammography was significantlyhigher in INT than CON: 76% v52% of INT v CON, respectively,received surveillancemammograms within 12months (P , .05).

Dudley18 QE; prospectivecomparison ofunmatched controlparticipants (CON;usual care) andinterventionparticipants (INT;usual care plus PNP)

County safety nethospital, UniversityHealth System (SanAntonio, TX)

PNP included a PN paired witha promotora.

PNs included a registered nurse,social worker, dentalhygienist, and a personwith anMBA who were trained innavigation and developedindividualized care plans on thebasis of patients’ individualand health system barriers.The PN focused on reducingmedical-related barriers,whereas the promotoraassisted with cultural orsocioeconomic barriers.

Navigation was throughcompletion of initial therapy.

N 5 461Median age:50.8 years

Race/ethnicity:Hispanic (52.5%)White (38.3%)Other (9.3%)

Primary language:English (66.1%)Spanish (32.6%)Other (1.3%)

Health insurance:Local government(69.7%)Medicare (10.9%)Private (19.4%)

Initiation of cancertreatment (time fromdiagnosis to initiationof primary treatment)

Completion of cancertreatment (time frominitiation tocompletion of primarytreatment)

Average time to treatment fromdiagnosis significantly differedby 17 days between CON (74days) and INT (57 days; P5 .042).This effect was morepronounced among Hispanicwomen (HR, 1.45; 95% CI, 1.09to 1.67; P 5 .02) who receivednavigation compared with usualcare (81 days [CON] v 56 days[INT]).

No statistically significantdifference was found intimeliness of treatmentcompletion between INT andCON.

Ell19 Prospective comparisonof participants whoreceived PNP (INT)and participants whodid not enroll ordeclined studyparticipation (CON;usual care)

Public and private urbanscreening, diagnostic,and treatment-referralcenters (Los Angeles,CA; New York, NY)

Patient navigation provided byPNs and social workers(MSWs).

PNs were bilingual (English,Spanish) and bicultural peercounselors; had a minimum ofa high school diploma andexperience working incommunity health careprograms; and providedtelephone-based adherencerisk/barrier assessment, healtheducation, appointmentreminders, individualizedcounseling, health caresystem navigation, andreferrals to MSW forpsychosocial counseling.

N 5 1,300For INT (n 5 605):Age:40-64 years (73%)

Race/ethnicity:Hispanic (71%)Black (18%)Other (11%)

Health insurance:Insured (56%)Uninsured (44%)

For CON (n = 695):Age: NRRace: NRHealth insurance: NR

Initiation of cancertreatment within 30days of diagnosis

No statistically significantdifference was found intimeliness of treatment initiationbetween a subsample of INT(n 5 64) and CON (n 5 10)participants with breast cancer:62% v 40% of INT v CON,respectively, initiated treatmentwithin 30 days after diagnosis.

Ell20 RCT; participantsrandomly assigned toreceive usual care(CON) or intervention(INT; PNP)

Public medical center(Los Angeles, CA)

PN was bilingual (English,Spanish) and providedtelephone-based adherencerisk assessment, healtheducation, counseling,systems navigation,reminders, and referrals tocommunity resources andMSW for psychosocialcounseling.

N 5 204Age:40-79 years (85%)

Race/ethnicity:Latina (85%)

Language:Non-English speaking(81%)

Health insurance: NR

Initiation of cancertreatment within 30days of diagnosis

Among a subsample ofparticipants with breast cancer(INT, n 5 5; CON, n 5 10), 80%of INT and 60% of CON initiatedtreatment within 30 days afterdiagnosis. Statistical analyseswere not performed due to smallsample size.

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Table 2. Summary of PNPs for Breast Cancer Treatment and Survivorship Care (continued)



Ell21 RCT that compared twoINTs; patientsrandomly assigned toenhanced usual care(CON; usual care pluswritten informationalmaterials) orintervention (INT;written informationplus PNP)

Urban public safety netmedical center (LosAngeles, CA)

Culturally tailored PNP wasdesigned to improve accessand adherence to adjuvanttreatment.

PN was bilingual (English,Spanish) and bicultural;assessed adherence barriersand risk; and provided healtheducation, decisional andemotional support, problemsolving, self-managementsupport, written resources,and referrals to MSW for briefcounseling.

Navigation services providedthrough telephone and/or inperson.

N 5 237Age:$ 50 years (55.7%)

Race/ethnicity:Hispanic (71.3%)

Language:English speaking(26.2%)

Health insurance:Local government(37.1%)Medi-Cal/Medicare(33.3%)Other (6.8%)Uninsured (22.8%)

Adjuvant treatmentadherence rates forcompletion of CT, RT,and HT

No statistically significantdifferences were foundbetween groups for overalladjuvant treatment adherencerates: 90% v 88% of CON v INT,respectively, completed CT;90% of patients in both groupscompleted RT. Overalladherence to HT was 59%, withno significant difference in ratesbetween groups.

Haideri22 Retrospective caseseries analysis ofpatients with breastcancer who receivedcare before (CON) andafter (INT)implementation ofPNP

Urban safety nethospital, TrumanMedical Center(Kansas City, KS)

PNs provided patients with cellphones for appointmentreminders; assistance withscheduling appointments andservices; communication withhealth care providers;educational information; one-on-one emotional support; andfinancial, insurance,transportation, and child careassistance.

N 5 322Median age:55.5 years

Race/ethnicity:White (49.7%)Black (47.8%)Other (2.4%)

Health insurance:Medicaid (39.4%)Medicare (31.1%)Private (9.9%)Uninsured (18.6%)

Initiation of cancertreatment (time frominitial presentation toinitiation of definitivetherapy)

Initiation of adjuvanttreatment (time fromsurgery to adjuvanttherapy)

After implementation of PNP, theaverage time from symptompresentation to first treatmentwas shorter by a median of 9days (42 v 33 days for CON vINT, respectively).

No statistically significantdifference was found in theaverage time from surgery toinitiation of adjuvant therapybetween groups (CON, 48 days[95% CI, 39 to 56 days]; INT, 43days [95%CI, 38 to 48]; P5 .62).

Ko23 Multicenter QE;comparison ofpatients who receivedcare before (CON) andafter (INT)implementation ofpatient navigation

Academic researchcenters (Boston, MA;Chicago, IL; Denver,CO; Columbus, OH;Rochester, NY; SanAntonio, TX; Tampa,FL; Washington, DC)

PNPs varied across eight PNRPsites, but all focused onimproving patient access totimely and quality cancer care.

PNs received training and basiceducation about breast cancertreatment and providedinformational and emotionalsupport to patients throughtheir course of care.

Navigation was from diagnosisthrough the end of cancertreatment (surgery, CT, RT).

N 5 1,004Mean age:56.2 years(SD, 11.4 years)

Race/ethnicity:Black (37.5%)White (36.3%)Hispanic (22.3%)Other (3.9%)

Language:English (79.1%)Non-English (20.9%)

Health insurance:Private (48.6%)Public (38%)Uninsured (13.4%)

Treatment adherencerates for receipt of HTand RT

INT was more likely to receive HTthan CON (OR, 1.73; 95% CI,1.19 to 2.53; P 5 .004; d 5 .43)when controlling for age, race/ethnicity, language, insurance,and site.

No statistically significantdifference was found betweengroups that received RT (OR,1.42; 95% CI, 0.80 to 2.54;P 5 .22; d 5 .28).

Koh24 Prospective study ofpatients with breastcancer who receivedPNP (INT) comparedwith matchedhistorical controls(CON)

Breast center ina tertiary care facility(Denver, CO)

PNP was provided to patientswith newly diagnosed breastcancer by an oncology nursewho coordinated their care.

Navigation was throughdiagnosis to end of cancer care(eg, patients transferred tocancer treatment center orother care provider)

N 5 110Mean age:56.5 years(SD, 12.28 years)

Race/ethnicity:White (90%)Black (5.5%)Hispanic (3.6%)Asian (0.9%)

Health insurance:Private (63.6%)Government (36.4%)

Initiation of cancertreatment (time fromdiagnostic biopsy toinitiation of cancertreatment)

On average, INT initiatedtreatment in 26.2 days (SD, 9.15days; 95%CI, 22.9 to 29.4 days),and CON initiated treatment in30 days (SD, 11.79 days; 95%CI, 26.8 to 33.2 days). Thisshorter mean treatment intervalfrom diagnostic biopsy wasnot statistically significant(t 5 1.606; P 5 .112; d 5 .366).

Lobb25 Retrospective study thatcompared patientswith breast cancerwho received carebefore (CON) and after(INT) implementationof case managementand free treatmentpolicy (FTP)

BCCEDP casemanagementprogram,Massachusetts

Case managers were required tohave current licensure ora national certificate in casemanagement and a bachelor’sdegree in health and humanservices or registered nurselicense in Massachusetts.They provided support,education, coordinated careand patient-physiciancommunication, assistancewith appointment scheduling,transportation vouchers, andinterpreter services andreduced health systembarriers.

N 5 442Age: NRRace/ethnicity:White (72.4%)Hispanic (17.9%)Black (8.4%)Asian (1.4%)


Initiation of cancertreatment (time fromabnormalmammogram toinitiation of cancertreatment)

After the implementation of a casemanagement program, time totreatment initiation fromabnormal mammogram wasreduced by 12 days, and anadditional 3 days after the freetreatment policy (57 v 45 v 42days for CON v INT v FTP,respectively; P 5 .001). Therewas also a 39% reduction in theadjusted RR of treatment delayafter implementing casemanagement, but the decreasein risk was not statisticallysignificant (RR, 0.61; 95% CI,0.33 to 1.14).

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health care institution–based safety net hospitals,18,21,22 publichospitals or medical centers,16,17,19,20,25,26 community-based healthclinics,25,27 tertiary care centers,16,24 and academic institutions.23,28

Study Participant CharacteristicsStudy sample sizes ranged from 100 to 1,300 participants.

Most study participants were middle-aged (50 years and older).

Most patient navigation interventions were provided to specificracial/ethnic or underserved populations. Six studies17-21,27 eval-uated the efficacy of patient navigation for low-income Hispanic/Latina women who were predominantly insured by government-sponsored health care programs (Medicaid, Medicare)18,21 or weremainly27 or exclusively17 uninsured. Spanish was the primarylanguage among the majority of participants in three of thesestudies.17,21,27 Two studies were conducted among African

Table 2. Summary of PNPs for Breast Cancer Treatment and Survivorship Care (continued)



Raj26 Retrospective, single-group study thatcompared patientswith breast cancerwho received PNP(INT) with previouslypublished data forpatients from NCCNcenters

Massachusetts GeneralHospital Avon BreastCare Program(Boston, MA)

PNs were culturally diverse,trained layworkers whoprovided patient navigationservices.

N 5 186Median age:58 years (range,19-93 years)

Race/ethnicity:White (32%)Hispanic (28%)Black (16%)Asian/MiddleEastern (4%)Not disclosed (20%)

Language:English (57%)Spanish (30%)

Health insurance:Private (31%)Medicare (24%)Medicaid (12%)Uninsured (6%)Unknown (23%)

Treatment adherencerates for receipt of HT,CT, and RT

INT had comparable treatmentadherence rates with NCCNpatients: 95% of INT and 89% ofNCCN received HT, 88% of INTand 87% of NCCN received CT,and 92% of INT and 95% ofNCCN received RT. Nostatistically significantdifferences were foundbetween rates.

Ramirez27 QE; prospectivecomparison ofpatients with breastcancer who receivedusual care (CON) andpatients who receivedPNP (INT)

Six community-basedhealth clinics (SanDiego, CA; SanFrancisco, CA; Miami,FL; New York, NY;Houston, TX; SanAntonio, TX)

The PNP was culturally tailoredfor Latinas with breast cancerand implemented acrossmultiple sites.

PNs were bilingual communityhealth workers with at leasta high school diploma ora college degree trained tocoordinate care and assistLatinas in using cancer careservices. They emphasizedadherence to diagnostic andtreatment plans andovercoming barriers to careand provided health education;emotional support;communication with healthcare providers; translationservices; accompaniment;appointment scheduling; andassistancewith transportation,child care, and healthinsurance issues.

Patients were contacted weeklyor as needed by telephone andreceived navigation services atleast once a month or asneeded.

N 5 109Age:$ 51 years (57.8%)

Race/ethnicity:Hispanic (100%)

Primary language:Spanish (60.2%)English (39.8%)

Health insurance:Uninsured (41.7%)Local government(32.4%)Private (18.5%)Medicare (7.4%)

Initiation of cancertreatment within 30 or60 days of diagnosis

INT was more likely to initiatetreatment within 30 days (69% v46.3% for INT v CON,respectively; P 5 .029) and 60days (97.6% v 73.1% for INT vCON, respectively; P 5 .001)after cancer diagnosis thanCON.

The average time from cancerdiagnosis to first treatment was48.3 days in CON (95%CI, 35.56to 61.04 days) and 22.22 days inINT (95% CI, 16.12 to 28.32days). The overall time totreatment initiation wassignificantly shorter in INT(HR, 1.60; P , .001).

Weber28 Retrospective cohortstudy that comparedpatients with breastcancer who receivedtreatment before(CON) and after (INT)implementation ofa PNP

East Carolina UniversityBrody Schoolof Medicine(Greenville, NC)

PN was a registered nurse;assisted patients inovercoming individual barriersto accessing cancer care; andprovided health education,emotional support, andresources for physical andpsychosocial support.

N 5 368Mean age:58.4 years (range,26-93 years)

Race/ethnicity:White (53.8%)Black (45.1%)Other (1.1%)


Treatment adherencerates for receipt of HT,CT, and RT

Adherence to post-treatment surveillancemammography

No statistically significantdifferences in treatmentadherence rates were foundbetween groups.

After implementation of PNP, thepercentage of patients whoreceived surveillancemammography within12 months significantlyincreased by 27% (53.5% v80.5% for CON v INT,respectively; P , .001).

Abbreviations: BCCEDP, Breast and Cervical Cancer Early Detection Program; CI, confidence interval; CON, control group; CT, chemotherapy; d, Cohen d effect size;FTP, free treatment policy; HR, hazard ratio; HT, hormone/hormonal (antiestrogen) therapy; INT, intervention group; MBA, Master of Business Administration; MSW,Master of SocialWork; NCCN, National Comprehensive Cancer Network; NR, not reported; OR, odds ratio; PN, patient navigator; PNP, patient navigation program; PNRP,Patient Navigation Research Project; QE, quasi-experimental; RCT, randomized controlled trial; RR, risk ratio; RT, radiation therapy; SD, standard deviation.




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American/black women22,28 who were primarily uninsured28 orreceived government-sponsored insurance.22 Three studies in-cluded ethnically diverse participants, including African American/black, Hispanic/Latina, and white women who mostly had privateinsurance.16,23,26 Two studies included predominantly whitesamples, one of which targeted low-income, uninsured women butdid not provide sample characteristics on income or health in-surance status,25 and the other included primarily participants whohad private health insurance.24

Intervention CharacteristicsAll studies used patient navigation as the primary intervention

mechanism and evaluated intervention outcomes in women withbreast cancer. However, the patient navigation interventions wereheterogeneous. Although most studies implemented a patientnavigation program for patients with breast cancer,16-18,22-25,27,28

many included some variation of or combined patient navigationwith another intervention component,19-21 such as psychosocialcounseling. Two studies used culturally tailored patient navigationprograms for Hispanic/Latina women with breast cancer.21,27 Onestudy used a two-team approach that paired a patient navigatorwith a promotora and was on the basis of a care managementmodel.18 Another study used a case management program.25

The personnel who provided navigation services varied amongstudies. Patient navigators were described as nurses,18,24,25,28 healthcare facilitators,22 outreachworkers,16 casemanagers,25 socialworkers,18

a dental hygienist,18 peer counselors,19 trained community healthworkers,27 and trained layworkers.26 Patient navigators in five studieswere bilingual in English and Spanish.17,19-21,27 Training of patientnavigators also varied.Whereas four studies specified that navigatorswere trained in patient navigation,17 identification and resolutionof barriers to care,16 care coordination for diagnostic evalua-tion and treatment,27 cultural competency,17,20 or case manage-ment and medical interpretation,17 details about the training(eg, length, delivery method, curriculum) and quality of training werelimited or not reported. In three studies, navigators received trainingbased on guidelines previously developed by the Institute for HealthPromotion Research27 or navigation training programs through thePatient Navigation Research Program,18,23 which are described ingreater detail elsewhere.30 In addition, three studies specified edu-cational or professional requirements for patient navigators, whichincluded at least a high school diploma or a college degree19,27 orcurrent licensure/certificate in case management with a registerednurse license or bachelor’s degree in health and human services.25

Patient navigation programs also varied in the services pro-vided, which were typically delivered through in-person meetings,telephone, or a combination of the two. Patient navigation servicesincluded health education about breast cancer, its treatments, andinformation about available services and resources16,17,19-23,27,28;emotional support16,17,19-23,27,28; assessment of barriers16,18,21;individualized action plans16,18,21; communication with the healthcare team22,25,27; coordination of care17,22,24,25; case management16,25;appointment scheduling and reminders16,19,20,22,25,27; accompanimentto appointments27; assistance with financial16,17,22 and healthinsurance22,27 issues; transportation services16,17,22,25,27; childcare arrangements16,22,27; and translation services.25,27 Navi-gation was generally provided from diagnosis to treatment

initiation,18 during the course of treatment,22 or throughtreatment completion.17,18,23,24

Efficacy of Patient NavigationThis article focuses exclusively on outcomes specific to breast

cancer treatment and/or survivorship, so results on cancer carebefore treatment (eg, diagnostic resolution) or subsequent tosurvivorship (eg, end-of-life care) are not included. All 13 studiesevaluated the effects of patient navigation on cancer treatmentoutcomes, and two evaluated post-treatment surveillance adher-ence, which was the only survivorship-related outcome identified.

Timeliness of care. Seven studies focused on the efficacy ofpatient navigation in improving the timeliness of cancer treatment,operationalized as the time to primary cancer treatment initiationfrom the date of initial breast abnormality/abnormal result22,25 ordiagnosis of breast cancer.18-20,24,27 Two studies that used a com-bined patient navigator and promotora intervention18 and a cul-turally tailored patient navigation program27 demonstrated thatnavigated patients were more likely to initiate treatment within 30and 60 days from breast cancer diagnosis than non-navigatedpatients27 and had, on average, significantly shorter times (P , .05)from diagnosis to treatment by 1718 or 2627 days in predominantlylow-income, uninsured, or publicly insured Hispanic/Latina pa-tient populations. This significant difference was also more pro-nounced among Hispanic/Latina women than white women.18

Two other studies reported that a greater percentage of navi-gated patients initiated treatment within 30 days; however, thesestudies were limited by small sample sizes and lacked statisticalsignificance.19,20 After the implementation of a patient naviga-tion program at an urban safety net hospital, navigated patientshad shorter times on average from symptom presentation totreatment by a median of 9 days.22 Although navigated patients hadshorter time to treatment by a median of 12 days from abnormalmammogram in a poor and underinsured/uninsured patientpopulation25 and by a mean of 4 days from cancer diagnosis ina predominantly white, privately insured sample,24 the differenceswere not statistically significant. Time from initiation to com-pletion of primary treatment and from treatment completion toinitiation of adjuvant therapy were also assessed,18,22 but patientnavigation was not associated with significant reductions.

Treatment adherence. Six patient navigation inter-ventions16,17,21,23,26,28 aimed to improve adherence to breast cancertreatment mostly presented nonsignificant results. Treatment ad-herence was operationalized as the receipt of radiation therapy,chemotherapy, and hormonal therapy. Two of these studies con-ducted RCTs to examine the effectiveness of patient navigation inimproving treatment adherence among patients with breast cancerwho required adjuvant therapy. Specifically, Ell et al21 evaluateda culturally tailored patient navigation program that included in-person and/or telephone-based navigation services in a predominantlyHispanic/Latina, Spanish-speaking, and unemployed population withpublic/government health insurance. Bickell et al16 evaluated an in-tervention that connected patients who required postsurgical adjuvanttreatment to targeted, high-quality, community-based cancer assis-tance programs in a predominantly privately insured patient pop-ulation. Both RCTs found no significant differences in treatmentadherence between patients with breast cancer who received


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navigation services (intervention) or usual care plus written in-formational materials (control).16,21 However, both intervention andcontrol groups had high overall adherence rates of radiation, che-motherapy, and hormonal therapy (range, 86% to 93%).

Patient adherence to radiation, chemotherapy, and hormonaltherapy was also evaluated through breast cancer care qualityindicators17,28 from the ASCO National Initiative for Cancer CareQuality31 and standard cancer treatment recommendations23,26

from ASCO/NCCN guidelines.32 Accordingly, treatment adher-ence was specified as the receipt of radiation therapy in womenwho had breast-conserving surgery17,23,26,28 and were youngerthan 70 years,23 receipt of chemotherapy in women younger than50 years17,23,28 or in women younger than 70 years with estrogenand progesterone receptor–negative breast cancer,23,26 and receiptof hormonal therapy for women with estrogen and/or pro-gesterone receptor–positive breast cancer.17,23,26,28 Although onestudy reported that navigated patients were more likely to receivehormonal therapy than non-navigated patients,23 patient naviga-tion was not significantly associated with receipt of radiation therapy,chemotherapy, or hormonal therapy in a predominantly Hispanic/Latina, Spanish-speaking, and uninsured patient population17 oramong African American/black and white patients with breastcancer.23,28 Similarly, another study reported comparable treatmentrates between navigated patients and NCCN patients,26 which werenot statistically different, and the specific details of the interventionsthat NCCN patients received were unclear.

Adherence to surveillance mammography. Two studies17,28

evaluated a survivorship outcome, which was adherence topost-treatment surveillance guidelines. On the basis of ASCOclinical recommendations,31 patients with noninvasive breastcancer (stage I to III) should obtain a mammogram after curativetreatment within 12 months. Both studies reported that surveillancemammography rates were significantly higher among navigated pa-tients by 24%17 and 27%28 (P , .05).

DISCUSSION

To our knowledge, this study is the most comprehensive systematicreview of patient navigation research focused on breast cancer

treatment and survivorship outcomes to date. The study improvedon previous narrative and systematic reviews by conductingsearches in multiple electronic databases, which extended thesearch to cover 25 years, and evaluated the quality of researchconducted. This review identified an increase in the number ofpatient navigation programs for breast cancer, including thenumber of studies that evaluated treatment and survivorshipoutcomes, as well as the implementation of patient navigation inmedically underserved populations. Consistent with the originalpurpose of patient navigation,11,33 most studies16-23,26-28 targetedethnic minorities and/or those with limited or without healthinsurance. The findings of this systematic review indicate there issignificant heterogeneity in patient navigation programs in termsof the delivery of intervention, navigation goals and services,personnel who provided navigation, intended audiences, andtargeted outcomes. The research that has evaluated the efficacy ofpatient navigation for breast cancer treatment and survivorshipwas of moderate quality, and the findings are mixed.

The primary outcomes targeted were timeliness of treatmentinitiation, adherence to cancer treatment, and adherence to sur-veillance mammography. Although all studies assessed the out-come variables by extracting data frommedical records, they variedin the operationalization and measurement of these outcomes,which made it impossible to conduct a meta-analysis. In general,limited evidence suggested that patient navigation improvestreatment outcomes in women with breast cancer. Although therewas some indication that those who received patient navigationhad statistically significant fewer days from diagnosis to treatmentinitiation compared with a control group in two studies (control vintervention, 74 v 5718 and 48 v 2227), other studies reported nosignificant benefit.19,20,24,25 The two studies18,27 that reportedsignificant improvements targeted Hispanic/Latina and AfricanAmerican/black populations that were predominantly insuredthrough local government insurance, which suggests that patientnavigation may be effective in improving cancer treatment initi-ation among medically underserved populations. The receipt oftreatment, 60 days from diagnosis is clinically significant, becausetreatment delays $ 60 days are associated with higher risks ofoverall and breast cancer–related death.6 In all but one treatmentinitiation study, both navigated and non-navigated patients

Table 3. Component and Global Assessment of Study Quality by Using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies

First Author Selection Bias Study Design Confounders Blinding Data Collection Method Withdrawals and Dropouts Global Rating

Bickell16 3 1 1 2 1 1 2Chen17 2 2 1 2 1 3 2Dudley18 2 2 3 2 1 1 2Ell19 2 2 3 2 1 3 3Ell20 2 1 1 1 1 1 1Ell21 1 1 1 2 1 2 1Haideri22 2 2 1 2 1 2 1Ko23 2 1 1 2 1 3 2Koh24 2 2 1 2 1 2 1Lobb25 2 2 1 2 1 2 2Raj26 2 3 3 2 1 NA 3Ramirez27 2 2 1 2 1 3 2Weber28 2 2 1 2 1 2 1

NOTE. Effective Public Health Practice Project ratings: 1 = strong, 2 = moderate, 3 = weak.Abbreviation: NA, not applicable.




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on average initiated treatment within the recommended60 days19,20,22,24,25,27; therefore, whether patient navigation hada clinically significant impact on treatment initiation or breastcancer disparities is not clear. Finally, many studies found thatpatient navigation did not significantly improve adherence tobreast cancer treatments,16,17,21,23,28 although navigated patientswere more likely to receive recommended hormonal treatmentsthan control subjects in one study.23 Because of the paucity ofstudies, results on the efficacy of patient navigation in improvingtreatment outcomes remain unclear. With regard to breast cancersurvivorship, two studies demonstrated greater adherence to post-treatment surveillance among navigated patients who had sig-nificantly higher rates of annual surveillance mammograms thannon-navigated patients (intervention v control, 76% v 52%17 and81% v 54%28). Although additional experimental studies are

needed to substantiate the patient navigation effects in survivor-ship, this finding agrees with previous research, which has con-sistently demonstrated the effectiveness of patient navigation atincreasing cancer screening rates.9,10,12

The findings from this review have significant implications forthe delivery of breast cancer care. Specifically, the limited evidenceof patient navigation in improving breast cancer treatment andsurvivorship outcomes underscores the need for additional studiesand evaluation before using patient navigation as part of standardoncology care. A growing movement has integrated patient nav-igation into cancer treatment and survivorship care despiteequivocal evidence of its efficacy. Since 1990,13 hundreds of patientnavigation programs have been implemented across the UnitedStates.34 In addition, as of 2015, cancer centers are required to havea patient navigation process in place for accreditation by the

Table 4. Metrics for Evaluating Patient Navigation During Breast Cancer Treatment and Survivorship

Domain Metric Description

Timeliness of care Cancer diagnosis date to first treatment date Time in number of days between datesOncology provider consultation date to firsttreatment date

Time in number of days between dates

Percentage with treatment initiation Percentage of patients who initiated treatment within30, 60, and 90 days

Time intervals between treatment modalities(eg, surgery to radiation/chemotherapy,radiation to surgery/chemotherapy,chemotherapy to hormone therapy)

Time in number of days between dates

Concordant start dates of treatments(eg, radiation and chemotherapy)

Yes/no

Treatment adherence Recommended surgery performed Yes/noRecommended chemotherapy received/completed

Yes/no

Recommended radiation therapy received/completed

Yes/no

Recommended hormone therapy received/completed

Yes/no

Chemotherapy treatments missed Number of chemotherapy cycles missed/omittedRadiation treatments missed Number of days radiation therapy treatments missedTreatment appointments missed Number of days on-treatment appointments missed

Guideline adherence Standard of care delivered; adherence to NCCNguidelines

Yes/no

Health care utilization/care coordination Unplanned hospitalizations; emergencydepartment visits

Number of (preventable) hospitalizations oremergency department visits during and aftercancer treatments

Ancillary services (eg, social work, psychologic/psychiatric therapy, physical therapy,nutrition) recommended/received

Yes/no

Patient-reported outcomesPatient satisfactionCancer-related care Patient Satisfaction with Cancer Care (PSCC)41 An 18-item measure of patient satisfaction with

diagnostic/therapeutic cancer-related careNavigation Patient Satisfaction with Interpersonal

Relationship with Navigator (PSN-I)42A nine-item measure of patient satisfaction withnavigator

Quality of life Functional Assessment of Cancer Therapy forBreast Cancer (FACT-B)43

A 44-item measure of physical well-being, social/family well-being, emotional well-being, functionalwell-being, relationship with physician, andadditional concerns in patients with breast cancer

Patient-Reported Outcomes MeasurementSystem (PROMIS)-2944

A 29-item measure of physical, mental, and socialhealth, which assesses seven domains(depression, anxiety, physical function, paininterference, fatigue, sleep disturbance, and abilityto participate in social roles and activities)

Impact of Event Scale (IES)45 A 15-item measure of subjective distress that resultsfrom exposure to major life events

NOTE. Adapted from recommendations for metrics to evaluate patient navigation during cancer diagnosis and treatment by Guadagnolo et al38 (Tables 1 and 2),recommended survivorship navigation outcomemeasures by Pratt-Chapman et al39 (Table 1), and recommended patient-reported outcomes to assess patient navigationby Fiscella et al40 (Table 1).Abbreviation: NCCN, National Comprehensive Cancer Network


Baik et al


American College of Surgeons Commission on Cancer.35 However,research has yet to establish the effectiveness of patient navigationafter patients have received a breast cancer diagnosis. In only onestudy18 was a significant difference found between the patientnavigation and control groups in which time to treatment fromdiagnosis was , 60 days in navigated patients and significantlydifferent and . 60 days in control subjects. And the strongestevidence to indicate that patient navigation is helpful in improvingadherence to surveillance mammography comes from two retro-spective observational studies,17,28 which have a higher likelihoodof bias and confounding than RCTs. Although most patients wouldbenefit from additional assistance, whether patient navigation hasa clinical benefit in those with breast cancer and in survivors isunclear. Also not clear is whether patient navigation is cost-effective inimproving outcomes in breast cancer treatment and survivorship. Acost-benefit analysis of patient navigation compared with usual care indicatedthat patient navigation was borderline cost-effective at $95,625 per life-year saved if navigated patients received a definite diagnosis of breastcancer 6 months earlier.36 However, the costs of navigating patients withbreast cancer during cancer treatment and the survival benefits oftreatment adherence (eg, reduced treatment delays, interruptions,incompletions) in terms of cost savings have not yet been evaluated.

This review has several limitations. Most study participantsweremiddle-age. However, this is consistent with national statisticsof increasing breast cancer incidence rates in women older than50 years, with 79% of new cases in this age-group.37 The search waslimited to studies conducted in the United States and published inEnglish-language peer-reviewed academic journals. Gray literaturewas also excluded; therefore, conference abstracts or unpublishedstudies were not obtained. In addition, studies that combined andanalyzed breast cancer with other types of cancers were excludedfrom the review, although they may have evaluated treatment andsurvivorship outcomes. Consequently, the review may not haveincluded all patient navigation studies in breast cancer. Further-more, the diversity in interventions and small number of identifiedstudies likely limit the generalizability of findings. Finally, a quantitativeanalysis of the findings was not conducted because of the heterogeneityof assessment and evaluation of outcomes. The lack of consistent as-sessment and reporting of treatment outcomes further limit the gen-eralizability of results.

Although growing support exists for patient navigation incancer care, additional research is needed to determine the efficacyand cost-effectiveness of patient navigation in breast cancertreatment and survivorship. Future research should comparevarious models of patient navigation with the same outcomes andshould adhere to the recommended metrics38,39 and patient-

reported outcomes40 for evaluating patient navigation duringtreatment and survivorship, which will facilitate comparisonsacross programs and a meta-analysis. Table 4 lists breast cancertreatment and survivorship outcomes based on previous recom-mendations.38-40 In addition, a more rigorous evaluation of patientnavigation interventions is needed. To date, there has been a lack ofRCTs that examine the efficacy of patient navigation in treatmentand survivorship outcomes, and much of the research has lackeda concurrent control group. Future research should be prospectiveand have a concurrent control group. To increase generalizability offindings, studies should recruit larger, ethnically diverse samplesand evaluate whether programs equally benefit all racial and ethnicgroups. Patient navigation research also lacks longitudinal studiesthat evaluate the long-term effects of patient navigation on im-proving clinical outcomes. Future studies should include longerfollow-up of patients with breast cancer for at least 5 yearspostnavigation and track the recurrence of cancer and survivaldata. Future research should also examine the processes by whichpatient navigation improves specific cancer-related goals to de-termine the components of the intervention that are most likely tobe associated with timely, high-quality, and recommended treat-ment or survivorship care and survival from breast cancer.

Despite widespread implementation of patient navigationprograms for patients with breast cancer and survivors, there is noconclusive evidence with regard to the efficacy of these programs.Two retrospective observational studies indicate that patientnavigation may be effective for surveillance mammography. Toenable comparison across studies, additional high-quality, pro-spective research with concurrent control groups are needed thatuse the same outcomes as previous studies.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTSOF INTEREST

Disclosures provided by the authors are available with this article atwww.jco.org.

AUTHOR CONTRIBUTIONS

Conception and design: All authorsCollection and assembly of data: Sharon H. BaikData analysis and interpretation: All authorsManuscript writing: All authorsFinal approval of manuscript: All authorsAccountable for all aspects of the work: All authors

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AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships areself-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For moreinformation about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or jco.ascopubs.org/site/ifc.

Sharon H. BaikNo relationship to disclose

Linda C. GalloNo relationship to disclose

Kristen J. WellsNo relationship to disclose

www.jco.org © 2016 by American Society of Clinical Oncology



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Documents

Patient Navigation in Breast Cancer Treatment and ... · patient navigation in improving treatment and survivorship outcomes in women with breast cancer. Methods The review included