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Health-Related Qualityof LifeAmong Long-TermSurvivors of

Colorectal Cancer:A Population-BasedStudy

AGNÈSCARAVATI-JOUVENCEAUX,

a,b

GUYLAUNOY,

c

DELPHINEKLEIN,

d

MICHELHENRY-AMAR,

e

EDWIGEABEILARD,

c

ARLETTEDANZON,

f

ASTRIDPOZET,

b

MICHELVELTEN,

d,g

MARIETTEMERCIER

a,b a Department ofBiostatistics, Universityof Franche-Comté,Besanc ¸on, France; b

Cancer ClinicalResearch

Unit, UniversityHospital JeanMinjoz, Besanc¸ on,France; c

Calvados DigestiveCancer Registry,University

Hospital, Caen,France;

d Department ofEpidemiology andPublic Health,Bas-Rhin CancerRegistry,

University ofStrasbourg, Strasbourg,France;

e Calvados CancerRegistry, Franc¸ oisBaclesseComprehensive

Cancer Center,Caen, France;

f Doubs CancerRegistry, Universityof Franche-Comté,Besanc ¸on, France; g Paul StraussComprehensive CancerCenter, Strasbourg,France Key Words.Colorectal cancer Long-termsurvivors Quality oflife Population-based study SF-36 QLQ-C30

Disclosures: Agne`sCaravati-Jouvenceaux:None;Guy Launoy:None;Delphine Klein:None;Michel Henry-Amar:None;Edwige

Abeilard:None;Arlette Danzon:None;Astrid Pozet:None;Michel Velten:None;Mariette Mercier:None.

Section editorEduardo Bruera:None;Russell K.Portenoy: Cephalon, CNSBio, GrupoFerrer, PurduePharma, Xenon(financial

relationships); Ameritox,Archimedes Pharmaceuticals,Cephalon, CovidienMallinckrodt Inc.,Endo Pharmaceuticals,Forest Labs,Meda

Pharmaceuticals, Ortho-McNeilJanssen ScientificAffairs LLD,Otsuka Pharma,Purdue Pharma,Tempur-Pedic Corporation(RF).

Reviewers "A"and "B":None.

(C/A), consulting/advisoryrelationship; (RF)Research funding;(E) Employment;(H) Honorariareceived; (OI)Ownership

interests; (IP)Intellectual propertyrights/inventor/patent holder

LEARNINGOBJECTIVES

After completingthis course,the readerwill beable to:

1. Comparequality oflife inlong-term colorectalcancer survivorswith qualityof lifein thegeneral population.

2. Identifycancer complicationsthat affectquality oflife inlong-term colorectalcancer survivors.

This articleis availablefor continuingmedical educationcredit atCME.TheOncologist.com.

CMECME

ABSTRACT

Background.The numberof long-termcolorectal cancer survivors isincreasing. Cancerand itstreatment can cause physicaland psychologicalcomplications, butlit- tle isknown abouthow itimpacts qualityof life(QOL) over thelong term - 5,10, and15 yearsafter diagnosis.

Methods.Cancer survivorswere randomlyselected

(?1 year),1995 (?1 year),and 2000( ?1 year).Controls were randomlyselected fromelectoral rolls,stratifying on gender,age group,and residencearea. Participants completed twoQOL questionnaires,a fatiguequestion-

naire, ananxiety questionnaire,and alife conditionsquestionnaire. Ananalysis ofvariance wasused tocom- pare QOLscores ofcancer survivorsby periodof diag-nosis (5,10,and 15years) withthose ofcontrols, adjusted forsociodemographic dataand comorbidi-ties.

Results.We included344 coloncancer and198 rectalcan- cer survivorsand 1,181controls. Ina globalanalysis, survi- in socialfunctioning 5years afterdiagnosis andhigher scoresin diarrhea symptoms5 and10 yearsafter diagnosis.In subgroup analyses, rectalcancer affectedQOL inthe physicaldimensions at 5years andin thefatigue dimensionsat 5and 10years.

Correspondence: AgnèsCaravati-Jouvenceaux, Ph.D.,Department ofBiostatistics -EA3181, Facultyof Medicine,University of

Franche-Comté, 2Place Saint-Jacques,25030 Besanc¸ onCedex, France.Telephone:33-3-81-21-88-97;Fax:33-3-81-66-52-99;e-mail:

acaravati@chu-besancon.fr ReceivedFebruary7,2011;acceptedforpublicationJuly27,2011;firstpublishedonlineinTheOncologist

Expresson October15, 2011.©AlphaMed Press1083-7159/2011/$30.00/0 http://dx.doi.org/10.1634/theoncologist.2011-0036

The

Oncologist

SymptomManagement andSupportiveCare

The Oncologist2011;16:1626-1636www.TheOncologist.com by guest on September 17, 2016http://theoncologist.alphamedpress.org/Downloaded from the effectsof cancerand itstreatment upto 10years afterdi-

agnosis, particularlyfor rectalcancer. Clinicians,psycholo- gists, andsocial workersmust payspecial attentionto rectalcancer survivorsto improveoverall management.The Oncol-

ogist2011;16:1626-1636

INTRODUCTION

Colorectal canceris thet hirdmost commonmalignancyin France, withan estimated40,000 newcases in2009, andit is the secondleading causeof cancerdeaths afterlung cancer, ern Europeand inother high-resourcecountries likethe U.S., Canada, andAustralia [3,4]. Thanksto advancesin screening, population, thenumber ofsurvivors ofcolorectal canceris in- creasing [5]. The treatmentsthat havehelped toimprove thecancer sur- vival ratecan causeseveral physicaland psychologicalreper- (HRQOL), particularlyduring thepostoperative period.Some other problemscan appearyears later[6 -8]. HRQOLinfor- mation onlong-term colorectalcancer survivorsis important in orderto evaluatethe fullspectrum ofimpact ofthe disease last decadehas understandingthe long-termeffects ofcancer become apriority. InFrance, thiswas enshrinedin theobjec- tives ofthe NationalCancer Planin orderto improveglobal management ofcancerpatients. Somestudies haveinvesti- gated theeffects ofcancer onQOL atleast 5years afterdiag- nosis [9-14].However,few werepopulation-based studies, focused oncolorectal cancerQOL, orperformed ona large scale. Nosuch studyhas beenperformed inFrance todate. tients randomlyselected fromthe Frenchregional cancerreg- istries ofthe Calvados,Doubs, andBas-Rhin departmentsto compare QOLof colorectalcancer survivors,considered as cured, 5,10, and15 yearsafter diagnosiswith thatof healthy controls.

MATERIALS ANDMETHODS

Survey Participants

All thecolorectalcancer survivorswere randomly selected from filesof threepopulation-based cancerregistries inthe Calvados, Doubs,and Bas-Rhindepartments inFrance. Pa- tients wereeligible ifthey weredisease freeand notunder written informedconsent. Toevaluate thetime effecton QOL, we definedthree survivalperiods: 5,10, and15 yearsafter di- agnosis. Wethus selectedthree colorectalcancer patient groups,diagnosedin2000(

1year),in1995(

1year),andin

1990 (

1 year).

of 2.2million inhabitants.In eachregistry area,controls wererandomlyselectedfromelectoralrolls,werematchedwithcan-cer patientsfor gender,and werestratified onage (?10 years)

and residencearea (urban,2,000 inhabitants;rural, ?2,000 inhabitants) atthe timeof thesurvey. Controlswere selected for eachtumor location(colon orrectum) andfor eachof the three survivingperiods (5,10, or15 years).Two controlswere selected percase.

Survey Procedure

National FrenchData ProtectionAuthority.

After selection,we checkedwith thecancer registriesda- tabase andthe treatingphysician thatthe patientshad notdied ified inthe registriesdata thatcontrols didnot havea priorhis- tory ofcancer. Data collectionstarted in2006. Selectedsubjects were mailed apackage including:(a) aletter presentingthe study aim signedby themedical departmentphysician (forcancer patients) orby thecoinvestigator incharge ofthe studyin the relevant registryarea (forthe controls),(b) aninformed con- sent form,(c) thequestionnaires, and(d) astamped returnen- velope. Personswho refusedto participatehad theopportunity Nonrespondents weresent areminder letterafter 1month.

Questionnaires

Participants completedstandardized validatedFrench lan- guage instrumentsaddressing QOL,fatigue, andanxiety, plus a livingconditions questionnaire.

The MedicalOutcomes Study36-item ShortForm

Health Survey(hereafter, SF-36)has 36items measuring eight dimensionsof healthstatus: physicalfunctioning, role limitation resultingfrom physicalproblems, rolelimitation resulting fromemotional problems,social functioning, mental health,bodily pain,vitality, andgeneral healthper- ceptions. Theeight dimensionscan becombined intothe physical componentsummary andmental componentsum- mary scores[15-17].

Cancer (EORTC)Quality ofLife Questionnaire-Core30

(QLQ-C30) assessesQOL with30 itemsmeasuring 15dimen- sions: aglobal healthscale, fivefunctioning scales(physical, daily activities,cognitive, emotional,and social),three symp- toms scales(fatigue, pain,and nausea/vomiting)and sixsin- gle-item scalesmeasuring symptomsor problems(dyspnea, insomnia, appetiteloss, constipation,diarrhea, andfinancial difficulties) [18,19]. The Frenchversion ofthe MultidimensionalFatigue In-

1627Caravati-Jouvenceaux, Launoy,Klein etal.

www.TheOncologist.com by guest on September 17, 2016http://theoncologist.alphamedpress.org/Downloaded from ventory (MFI-20)was usedto evaluateparticipants' fatigue.It is a20-item questionnairemeasuring fiveaspects offatigue: general fatigue,physical fatigue,reduced activity,reduced motivation, andmental fatigue[20, 21].

Anxiety wasassessed usingthe Frenchversion ofthe

Spielberger State-TraitAnxiety Inventory(STAI). Itcontains ent anxiety)and traitanxiety (thegeneral levelof anxietyex- perienced andlinked topersonality). Theglobal scorefor each ent study[22]. to a0 -100scale.Forfunctional scales,higher scoresindicate better perceivedheath (SF-36,five dimensionsin theQLQ- a higherlevel ofproblems (ninedimensions inthe QLQ-C30,

MFI, andSTAI).

In additionto theaforementioned questionnaires,we col- lected informationabout family,social, professional,and co- morbid conditionsusing aquestionnaire entitledLiving in previousFrench surveys[23-25]. Thisquestionnaire re- cords datao neducational level,marital status,number of children, socialand familyrelationships, professionalsta- tus, monthlyincome, anduse ofmedical services(health in- surance, typeand numbero fcomorbidities, treatments, number ofvisits totreating physicianor specialists,hospi- talization). Priorto thesurvey, thefive questionnaireswere tested in30 subjects(15 casesand 15controls, 10per reg- istry area)not subsequentlyenrolled inthe population study. For cancersurvivors, informationon clinicalvariables (date ofdiagnosis, tumorextension, surgery,radiotherapy, chemotherapy, andstoma) wasretrieved frommedical re- cords.

Statistical Analysis

Descriptive analysiswas performedusing the?

2 test forcate - gorical variablesand Kruskal-Wallisnonparametric testfor were treatedaccording topublished recommendations. Briefly, forthe QLQ-C30,SF-36, andMFI questionnaires, missing itemswere attributedvalues equalto theaverage of the itemsthat werepresent, providedat leasthalf theitems on thescale wereanswered. Forthe STAIquestionnaire, 17 of the20 itemsat leasthad tobe answeredto calculatethe score, andmissing items(maximum ofthree) wereattrib-

19, 21,22].

mographic andhealth variables)in therelation betweenQOL scores andcancer, weperformed multivariateanalysis ofvari- ance incontrols separatelyfor eachQOL instrument. For multivariateanalyses, afour-level categoricalvariable to compareeach ofthree survivorgroups withcontrols was

created.Analysisofvariancewasperformedadjustingforcon-founding variablesfound tobe significantlylinked toQOL scores inthe previousstep. Consideringthe studydesign, reg-istry areas(Calvados, Doubs,Bas-Rhin), agegroup (18-54 years, 55-64years,65-74 years,?75 years),gender, andres-

idence area(urban versusrural) weresystematically included as explanatoryvariables. Followingthis analysis,score ad- justed meanswere computed.Statistical scoremean differ- clinical significance,we reliedon thevalues generallyin use, according toOsoba etal. [26].That is,on ascale of0 -100,a difference of5-10 unitswas consideredsmall, adifference of

10-20units wasconsidered moderate,and adifference ?20

units wasconsidered large.A difference?5 unitswas consid- ered asnot clinicallysignificant. First, globalanalysis wasperformed inthe wholesample (both tumorlocations andboth genderstaken together).Then, analyses bysubgroups wereconducted accordingto tumorlo- cation (colonand rectum)and gender.All analyseswere per- formed usingthe samemethodology. Thestatistical analysis software SAS,version 9.1(SAS InstituteInc., Cary,NC) was used toanalyze data. Considering thegeneral resultsof QOLstudies regarding score variability,the presentstudy wasdesigned tobe ableto detect adifference ?10 pointson ascale of0 -100when the standard deviationof thedifference wasequal to60 (ina matched settingwith twocontrols percase). Witha first-type error of0.01 anda powerof 90%,this required536 casesto be recruited. Consequently,approximately 670cases, withan ex- pected participationrate of80%, and2,100 controls,with an expected participationrate of50%, neededto beselected.

RESULTS

Participation Rateand ParticipantCharacteristics

Taking intoaccount theparticipation rate,1,582 eligiblecolo- rectal cancersurvivors were selected.Ofthese, 1,458 were contacted and542 acceptedparticipation andfully completed the questionnaires - 64%coloncancer and36% rectalcancer. gradually withincreasing timesince diagnosis(from 39%at 5

1,181 completedthe questionnaires.The responserate aver-

aged 28%over thethree regions(30% inCalvados, 28%in

Doubs, and27% inBas-Rhin) (Fig.1).

The mainreasons givenfor refusalto participatewere that too disabled.Indeed, nonparticipantswere olderthan partici- pants - 75.9 yearsversus 70.8years (p?.0001) forcases and

72.9 yearsversus 70.2years (

p?.0001) forcontrols - and the percentage ofwomen washigher amongnonparticipants had survived?15 yearsthan theparticipants inthe samepe- riod (26.5%versus 18.3%;p?.0003). Baseline sociodemographiccharacteristics ofcases and controls arepresented inTable 1.There wereno statistically

1628HRQOL inColorectal CancerSurvivors

by guest on September 17, 2016http://theoncologist.alphamedpress.org/Downloaded from nificant differencein thedistribution ofcases inthe 15-year survivors groupbetween Calvadosand Bas-Rhin. survivors hadsurgery, butmore rectalcancer survivorsmain- tained apermanent colostomy.They receivedmore radiother- apy, butnot significantlymore chemotherapy,than colon cancer survivors.According tothe tumor-node-metastasis classification, coloncancer survivorswere diagnosedwith a higher stageof tumorthan rectalcancer survivors.

Variables Relatedto QOLin Controls

According tothe resultsof themultivariate analysisof vari- ance, agegroup, gender,marital status,living alone,level of education, employmentstatus, income,comorbid conditions

and lengthof hospitalstay significantlyinfluenced allscales (p.01). Asa result,all thesevariables wereincluded inthe

subsequent analysisof variance.

Comparison ofQOL BetweenSurvivors

and Controls

Global Analysis

On theEORTC QLQ-C30questionnaire, cancersurvivors

showed significantlydifferent adjustedmean scoresthan con- trols fortwo scales,namely, socialfunctioning anddiarrhea. We founda clinicallysignificantly lowerscore at5 yearsafter diagnosis forthe socialfunctioning scalein cancersurvivors (Table 3).On thediarrhea scale,we observeda clinicallysig- nificantly higherscore, qualifiedas moderateat 10years and

Figure 1.Flowchart ofthe studypopulation.

1629Caravati-Jouvenceaux, Launoy,Klein etal.

www.TheOncologist.com by guest on September 17, 2016http://theoncologist.alphamedpress.org/Downloaded from small at5 yearsand 15years afterdiagnosis, incancer survi- vors thanin controls(Table 3).OntheSF-36,MFI-20,andSTAIquestionnaires,therewas no clinicallysignificant differencein anyof theQOL scoresTable 1.Baseline characteristics( n1,723)

CharacteristicColorectal cancersurvivors

5 yrsn248n(%)10 yrsn195n(%)15 yrsn99n(%)Controlsn1,181n(%)p-value

a

Registry.01

Calvados 96(38.7) 79(40.5) 25(25.2) 487(41.2)

Doubs 80(32.3) 53(27.2) 29(29.3) 362(30.7)

Bas-Rhin 72(29.0) 63(32.3) 45(45.5) 332(28.1)

Age, yrs.12

7595 (38.3)90 (46.2)41 (41.4)493 (41.7)

65-7469 (27.8)63 (32.3)36 (36.4)372 (31.5)

55-6460 (24.2)33 (16.9)16 (16.1)317 (17.6)

18-5424 (9.7)9 (4.6)6 (6.1)147 (9.2)

Gender.09

Male 141(56.8) 115(59.0) 51(51.5) 601(50.9)

Female 107(43.2) 80(41.0) 48(48.5) 580(49.1)

Area ofresidence .40

Rural 73(29.4) 52(26.7) 25(25.5) 288(24.4)

Urban 175(70.6) 143(73.3) 74(74.5) 893(75.6)

Marital status.58

Single 9(3.8) 10(5.2) 6(6.1) 68(5.8)

Married/living maritally177 (74.7)139 (72.8)68 (69.4)804 (68.6) Separated/divorced/widowed 51(21.5) 42(22.0) 24(24.5) 300(25.6)

Living alone.21

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