淋巴瘤患者对临床试验认知度与接受度及动机的调查分析

Analysisoftheperceptionsandattitudestoparticipateinradicalandpalliativeclinical

2 trialsamongChineselymphomaandhead/neckcancerpatients

3

4 Qiu-HuanKong1,2*MD,Lu-PingYang1,2*MD,Yue-RongLai2,3MD,Hui-YingQin2,4MD,

Lian-ZhuHe2,5MD,Yu-ShanLiu1,2MD,Yan-ErLi2,5MD,Xiu-JinChen2,5MD,Miao-Zhen

Qiu1,2?MD,PhD,Zi-XianWang1,2?,?MD,YuWang1,2*,?,?MD,PhD

1.DepartmentofMedicalOncology,SunYat-SenUniversityCancerCenter,Guangzhou

510060,China

2.SunYat-senUniversityCancerCenter;StateKeyLaboratoryofOncologyinSouthChina;

CollaborativeInnovationCenterforCancerMedicine,Guangzhou510060,China

11 3.Departmentof GynecologicalOncology,SunYat-SenUniversity CancerCenter,

Guangzhou510060,China

4.DepartmentofNursing,SunYat-SenUniversityCancerCenter,Guangzhou510060,China

5.DepartmentofClinicalResearch,SunYat-SenUniversityCancerCenter,Guangzhou

510060,China

*Qiu-HuanKong,Lu-PingYang,andYuWangcontributedequallytothiswork.

?Jointseniorauthors.

?Correspondingto:

19 YuWang,DepartmentofMedicalOncology,SunYat-SenUniversityCancerCenter,651

1

1

2

3

4

5

6

7

DongFendRoadEast,Guangzhou510060,China;TelandFax:+86-20-87343765;E-mail:

wangyu@

Zi-XianWang,DepartmentofMedicalOncology,SunYat-SenUniversityCancerCenter,

651DongFendRoadEast,Guangzhou510060,China;TelandFax:+86-20-87343795;

E-mail:wangzx@

2

Abstract

Objective:Thepurposeofthisprospectivestudywastoinvestigatetheperceptionsand

attitudestoparticipateinradicalandpalliativeclinicaltrialsamongChineselymphomaand

head/neckcancerpatients.

PatientsandMethod:Aself-developedquestionnairewasadministeredtohospitalized

patientsintheDepartmentofMedicalOncologyinSunYat-SenUniversityCancerCenter

between20September2014and20September2015.Thisstudyincludedlymphomapatients

8 whowereenrolledintoaradicaltreatmentclinicaltrial,andhead/neckcancerpatients

participatinginapalliativeclinicaltrial.

Results:Therewere136lymphomapatientsand87head/neckcancerpatientswho

completedandreturnedthequestionnaire.Thequestionnairereturnratewas100%.More

than90%ofthepatientsinbothgroupsshowedtrustandacceptanceformedicalcare

13 personnel,andmorethan50%ofthepatientsinbothgroupswereinhopeoftryingnew

medication,receivingfreemedication,andreceivingnewtreatmentatanearlierrate.As

comparedwiththoseintheradicaltrials,patientsinthepalliativeclinicaltrialsweremore

likelytohopetotrynewmedication(P<0.001)andreceiveanewtreatmentatanearlierdate

(P=0.025),butlesslikelytohopetoreceivefreemedicationP=0(.047).

Conclusions:Thisstudyrevealsseveralsharedperceptionsandneedsofpatientsinboththe

radical(lymphoma)andpalliative(head/neckcancer)settingsandexploresthedifferencesin

3

1

2

3

4

5

patients’attitudesbetweenradicalclinicaltrialsandpalliativeclinicaltrials.Thesefindings

mayprovideabasisforimprovingrecruitmentofpatientsfordifferenttypesofclinicaltrials

andensuringthatpatientshaveabetterunderstandingofclinicaltrials.

Keywords:radicalclinicaltrials;palliativeclinicaltrials;differencesinperception;new

treatment;freemedication;patientrecruiting

6

7

4

Introduction

Clinicaltrialsrefertoanyinvestigationinhumansubjectsintendedtodiscoverorverifythe

3 clinical, pharmacological and/or other pharmacodynamiceffects of one or more

investigationalmedicinalproduct(s),and/ortoidentifyanyadversereactionstooneormore

investigationalmedicinalproduct(s)and/ortostudyabsorption,distribution,metabolismand

excretionofoneormoreinvestigationalmedicinalproduct(s)withtheobjectofascertaining

7 its(their)safetyand/orefficacy.[1]Historicaldatarevealsthat<2%ofallforeigncancer

patientsparticipateinclinicaltrials,[2]andinspiteofthefactthatmoredomesticclinicaltrials

havebeeninitiatedinrecentyears,<1%ofChinesepatientsparticipateinclinicaltrials.[3]

Accordingly,tofurtherpromotethedevelopmentofclinicaltrials,andmaximizethebenefit

intermsofdeterminingtheefficacyandsafetyofexperimentaldrugs,itwillbenecessaryto

12

gainabetterunderstandingoffactorsinfluencingtheparticipationofpatientsintrials.A

13

growingnumberofclinicaltrialsinvolvinganti-cancerdrugsarebeingconducted,and

clinicaltrialsarebecomingincreasinglycommonplaceinChina.Nevertheless,therehave

beennosystematicdomesticstudiestoelucidatefactorsinfluencingtheperceptionsand

attitudesofpatientsparticipatinginradicalandpalliativeclinicaltrials,andthedifferencesin

17 suchfactors.InlightofthebackgroundofclinicaltrialsinChina,wedesignedatargeted

questionnairetoinvestigatetheperceptionsandattitudesofdomesticpatientswithlymphoma

orhead/neckcancerparticipatinginradicalandpalliativeclinicaltrials,respectively,thatthe

5

1

aimofthisstudyistoprovidereferencedatathatcanbeusedtoimprovetheimplementation

2

ofvarioustypesofclinicaltrials.

3

Patientsandmethods

4

Onehundredthirty-sixpatientswithconfirmeddiagnosesoflymphomaand87patientswith

5

head/neckcancerundergoingtreatmentinSunYat-SenUniversityCancerCenterbetween20

6

September2014and20September2015wereenrolledinthecurrentstudy.Thepathologic

7

andimmunohistochemicalresultsofallpatientswerereviewedinconsultationwith

8

DepartmentofPathologyofSunYat-SenUniversityCancerCenter.

9

Thelymphomagroupwasdesignatedgroup1(theradicalclinicaltrialgroup)withthe

followinginclusioncriteria:1.pathologically-confirmedlymphoma;2.participationina

clinicaltrialfortheradicaltreatmentoflymphomainSunYat-SenUniversityCancerCenter;

3.willingnesstocompleteaclinicaltrialintentionsurveyform;4.age≥18yearsand

independentawarenessandbehaviorability;and5.treatmentwithatleastonecourseof

chemotherapyusingaclinicaltrialdrug.

15

Thehead/neckcancergroupwasdesignatedgroup2(thepalliativeclinicaltrialgroup),

16

andhadthefollowinginclusioncriteria:1.pathologically-provensquamouscellcarcinomaof

17

thehead/neck;2.participationinaclinicaltrialofpalliativetreatmentofrelapsedrefractory

18

squamouscellcarcinomaof

thehead/neckinSun

Yat-SenUniversityCancerCenter;

19

3.willingnesstocompletea

clinicaltrialintention

surveyform;4.age≥18yearsand

6

1 independentawarenessandbehaviorability;and5.treatmentwithatleastonecourseof

chemotherapyusingaclinicaltrialdrug.

3 Clinicaltrialnursesdistributedandcollectedthesurveyformtothemembersofthedrug

trialgroupsonaunifiedbasis.Theanonymousquestionnairesurveymethodwasusedinthis

5 survey,andatotalof223questionnairesweredistributed.Thisstudywasrecordedand

approvedbytheEthicsCommitteeofSunYat-SenUniversityCancerCenter.

7

Followingareviewoftheliteratureandconsultationwithexperts,thesurvey

8

questionnairewasdesignedforthisstudy.Thequestionnaireconsistedoftwomajorparts.

Oneistheclinicalandsocialcharacteristicsofpatientsinbothgroups.Thecharacteristicsof

patientsincludedage,gender,ECOGperformancescore,familyandeducationalstatus,

religion,annualincome,insurance,andsourceofmedicalinsurance,whetherthetreatment

wascurative,whetherornotthepatientreceivedfreemedication.Andtheotherpartincluded

thecontentoftheperceptionsandattitudestoparticipateinclinicaltrialofthepatientsin

bothgroups(seeSupplementarytable).

15 SPSS19.0statisticalsoftwarewasusedforstatisticalanalysis.Dataobtainedfromthis

studywassubjectedtodescriptivestatisticalanalysis,yieldingtheagegroupsofpatients

17 participatingin theradicalandpalliative clinical trials, genderratios,ECOG score

characteristics,andtheperceptionsandattitudestowardthetrials.Achi-squaredtestwas

usedtocomparetheclinicalandsubjectivefactorsofthepatientsparticipatingintheradical

7

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7

andpalliativeclinicaltrials,andfactorsthatmayhaveinfluencedthepatients'participationin

thetrialsweresubjectedtounivariateanalysis.Multivariatelogisticregressionanalysiswas

usedtoassessandidentifyindependentfactorsinfluencingpatients'perceptionsandattitudes

towardclinicaltrialstheyparticipated.APvalue<0.05wasdefinedasastatistically

significantdifference.

Results

Atotalof223patientscompletedthesurvey,andthequestionnairereturnratewas100%.

9

Thesubjectsincluded136patientswithconfirmedlymphomaswhoparticipatedin

10

lymphomaclinicaltrialsaimedtoberadical,and87patientswithconfirmedcancersofthe

11

head/neckwhoparticipatedinaclinicaltrialforpalliativetreatment.Theclinicalandsocial

12

characteristicsofpatientsinbothgroups,andthecharacteristicsofthetrialsinwhichthey

13

participatedareshowninTable1.

14

Mostoftheclinicalandsocioeconomiccharacteristicswerebalancedbetweenpatientsin

15

theradicalandpalliativegroups.However,ahigherpercentageofpatientsinthepalliative

16

grouphadapoorerperformancestatusthanintheradicalclinicaltrials(11.5%vs.1.5%,

17

P=0.001),andpatientsintheradicalgrouphadahigherpercentageofreceivinginitial

18

treatmentthanthoseinthepalliativegroup(52.2%vs.26.4%,P=0.001).

19

Thedifferencesbetweenperceptionsandattitudestowardclinicaltrialsamongpatients

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1

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3

4

5

6

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8

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13

betweengroupsareshowninTable2.Morethan90%ofthepatientsinbothgroupsshowed

trustandacceptanceformedicalcarepersonnel,hopedtobenefitthemselves,orchoseto

participateintrialsperspecialists’recommendation,andmorethan50%ofthepatientsin

bothgroupswereinhopeoftryingnewmedicationin advance,receivingfreemedication,

contributingthemselvestomedicalresearch,receivingbettermedicalcare,andreceivingnew

treatmentatanearlierrate. Ascomparedwiththoseintheradicalgroup,patientsinthe

palliativegroupweremorelikelytohopetotrynewmedication(87.4%vs.66.2%,P<0.001),

tohopethatparticipationinthetrialwouldbenefitothers(81.6%vs.67.6%,P=0.022),tobe

dissatisfiedwiththeircurrenttreatment(28.7%vs.14.7%,P=0.011),tobelievethattherewas

noothereffective treatmentmethod(46.0% vs.33.1%,P=0.002),andto hopethat

participationinthetrialwouldenablethemtoreceiveanewtreatmentatanearlierdate

(88.5%vs.76.5%,P=0.025),butlesslikelytohopetoreceivefreemedication(50.6%vs.

64.0%,P=0.047).

14 The results of multivariate logistic analysesdemonstratedindependentfactors

influencingpatients’perceptionsandattitudesowardtclinicaltrials(Table3).Ascompared

withthoseintheradicalgroup,patientsinthepalliativegroupmorecommonlyhopedtotry

newmedication(HR,3.32;P=0.002),benefitothers(HR,2.79;P=0.004),andreceivenew

treatmentatanearlierdate(HR,2.37;P=0.028),andbelievedthattherewasnoother

effectivetreatment(HR,2.07;P=0.012).

9

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8

9

AsshowninTable3,havingkidsandlivingintownwereassociatedwithpatients ’hope

totrynewmedicine;patientsagedover60weremorelikelytohold hopetobenefitothers

andlesslikelytofeeldissatisfiedwithcurrenttreatmentthanyoungerones;patientswith

higherincomeandthosewithreligionhadahighertendencytowardsdissatisfactionwith

theircurrenttreatment;townandcityresidentsaswellaspatientswithhigherincomesless

commonlyhopedforfreemedication;andpatientsreceivinginitialtreatmentweremore

likelytohopetobenefitothersandlesslikelytobelievethattherewasnoothereffective

treatment.

Discussion

Thepresentprospectivestudyinvestigatedseveralaspectsofperceptionsandattitudesamong

lymphomapatientsinradicalclinicaltrialsandhead/neckcancerpatientsinpalliativeclinical

trials.Wefoundthatthemajorityofpatientsinbothgroupswereinhopeoftryingnew

medicationandreceivingfreemedication.Ascomparedwiththoseinthepalliativegroup,a

higherpercentageofpatientsintheradicalclinicaltrialgroupenteredtheclinicaltrialhoping

16 toreceivefreemedication,whichsuggeststhatpatientsinradicalclinicaltrialsmightbe

moreconcernedabouteconomicfactorsthanthoseinpalliativetrials.However,thisobserved

associationmightbeexplainedbythehigherpercentageofpatientsintheradicalclinicaltrial

groupwithlowincomesasthisassociationbecameinsignificantinmultivariateanalysis.In

10

1 contrast,multivariateanalysisdemonstratedthataccesstoanewdrugornewtreatmentwas

2

moreattractivetopatientsparticipatinginpalliativetrialsthanthoseinradicaltrials.One

3

possibleexplanationisthatmost(>70%)ofthepatientsinthepalliativegrouphadfailed

4

initialtreatmentandurgedforanewdrugofferingimprovedeffectivenessandlengthened

5

survival.

6

Ofnote,multivariateanalysesalsorevealedseveralotherfactorsinfluencingpatients’

7

attitudestoparticipateinclinicaltrials,regardlessoftheradicalorpalliativesetting.These

8 factorsalsoneedattentionandcouldcastlightonhowtoconductthesetrialsmorehumanely

9 andbetteraccepted.Forinstance,patientswithkidsmorecommonlyhopedforanewdrug

10

thanthosewithoutkids,whichimpliedsupportandadvicefromoffspringwasveryimportant

11

andcouldbeofgreatassistanceinconvincingpatientswhoheldwronglynegativeopinions

12

ofnewdrugs.

13

Thisstudyalsofoundthatthevastmajority(>90%)ofthepatientsinboththeradical

14

andpalliativegroupsparticipatedin

aclinicaltrialduetotrustinthehospitalandtheir

15

specialists,andnegativeattitudessuchasdissatisfactionwithcurrenttreatmentwerenot

16

commonmotivesforparticipatingin

clinicaltrials.Trustshouldbeconsideredasacrucial

17

factorindecisionmakingconcerningclinicaltrialparticipation.Areviewofinternational

18

researchresultssuggeststhattherearedifferencesinChinesepatients’andinternational

19

patients’trustwhendecidingwhetherornottoparticipateinclinicaltrials.Specifically,

11

internationalpatients'willingnesstoenteraclinicaltrialischieflyinfluencedbytheirfamily

physicians[4-6],butpastresearchsuggeststhatAsianpatients'willingnesstoparticipateina

3 clinicaltrialischieflyinfluencedbytheviewsoffriendsandrelatives[7-9].Inthisstudy,

however,patients'decisionsweremoststronglyinfluencedbyspecialistphysiciansinboth

5 theradicalandpalliativegroups.Thisfindingmayreflectdifferencesindomesticand

internationalmedicalsystemswherepatientstendtorelymoreonthedoctorwhoarecloseto

themandearntheirtrustthroughtheclinicalpracticeprocessinthefirstplace.Thisattitude

isreflectedintheincreasinglypositiveperceptionofclinicaltrialsamongpatientsinChina

duringrecentyears.

10 Economiccompensationremainscontroversialinpractice.Internationalresearchhas

shownthateconomiccompensationmayconstituteahindrancetotheimplementationof

clinicaltrialsbecausewhileexperimentaldrugstendtobecostlyanddifficulttoobtain,

economiccompensationprovidedbyresearchorganizationsoftencausessubjectstoengage

inwildspeculation.[10]Incontrast,otherstudieshaveshownthateconomiccompensation,

15 suchasmealsubsidiesorfreeparking,willencouragepatientstoparticipateintrials [11-15].

Thecurrentstudyshowedthatpatientsinbothradicalandpalliativegroupshopedtoreceive

freemedication,andthatpatientswithalowerincomeweremorelikelytohopetoreceive

freemedication.Thesefindingssuggestthateconomiccompensationmightexertapositive

influenceonsomeChinesepatients'decisionsregardingparticipationinaclinicaltrial,

12

1 particularlyconsideringthecharacteristicsofthemedicalsystemofChina.Becauseour

hospitalisafirst-rate3Aoncologyhospital,mostofthepatientsseekingcareatthishospital

3

haverelativelyfewmentalreservationsaboutparticipationinaclinicaltrial.

Furthermore,

4

therearedifferencesinhealthinsurancesystemsinChinaandabroad.Not

everyoneis

coveredbythehealthinsurancesysteminChina,andsomeruralmedicalinsurancepolicies

6 havelow reimbursementrates.Patientsreceiving medical treatmentin China may

consequentlyhaveagreatereconomicburdenthantheirinternationalcounterparts,and

8 domesticpatientsparticipatingin clinical trialswill haveagreaterdemandfor free

medicationoreconomiccompensation.

10 Chineseclinicaltrialsarestillatanearlystagewithrespecttoscaleanddevelopment,

andtherehavebeenfewattemptstoassesstheperceptionsofChinesepatientsparticipating

intrials,andmostofthesestudieshavefocusedondifferencesinperceptionsamongpatients

consentingorrefusingtoparticipateintrials.[16]Thiswasthefirststudytocomparethe

differentperceptionsandneedsofChinesepatientsparticipatingindifferenttypesofclinical

trials(radicalvs.palliative),andalsobrokegroundwithitslarge-scalecomparisonofthe

perceptionsandattitudesofChinesepatientsparticipatingindifferentclinicaltrials.

17

Apartfromthefactorsdiscussedabove,previousstudiesfoundthatpropagandaand

18

educationaddressingtrialinformationcouldinfluencethepatients

ttitudes’andperceptions

19

towardclinicaltrialsaswell.Thevariationinknowledgeofclinical

trialsheldbyprimary

13

carephysiciansandnursepractitionerscouldresultindifferentefficiencyinpatientaccrual

2 andhencedifferentprobabilityofrecruitmentofparticipants.[17-18]Ourinstitutionisa

high-volumecancercenterandthedoctorsandnursesinourinstitutionarewell-knownof

clinicaltrialsandcanadequatelyinformparticipantsofwell-organizededucationaboutthe

trialtheysignedin,whichguaranteesahighproportionofpatientsrecruitedinclinicaltrials

6 fromourinstitution.Moreover,briefmultimediapsychoeducationalinterventionwasalso

7 provedtobeabettertoolforimprovingpatients ’perceptionscomparedtotraditionaltedprin

educationalinformation.[19]

Thisstudyhasseverallimitations.Firstofall,Kaplanetal.[20]concludedthatpatients

withaproactive,optimisticattitudewillaccountforarelativelylargeshareofclinicaltrial

11

participants;however,becausethecontentof

thequestionnaireinthisstudydidnot

12

investigatetheeffectofpatientmentalstatuson

participationinclinicaltrials,thissubject

needsfurtherresearch.Second,onlylimitedcancertypesforradicalandpalliativeclinical

trialswereenrolledinthisstudy,whichmighthaveconfinedextensionoftheconclusionto

othertumors.Third,therewasnoquality-controlquestionsetinthequestionnaire,which

howeverdidnotimpairthepowerfulnessoftheanalysisresults.

17 Inconclusion,thisstudyrevealsseveralsharedperceptionsandneedsofpatientsinboth

18 theradical(lymphoma) andpalliative (head/neckcancer)groupsandexploresthe

differencesinpatients’attitudesbetweenradicalclinicaltrialsandpalliativeclinicaltrials.

14

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4

5

6

7

Weshouldestablishdifferentpointsofemphasiswhencommunicatingwith patients

consideringparticipatingindifferenttypesofclinical trials.Wehopethetrendsand

tendenciesdiscoveredbythisstudycouldalsoprovideabetterbasisforrecruitingspecific

patientsfordifferenttypesofclinicaltrialsandinstillingcorrectperceptionsofclinicaltrials

amongChinesepatients.

Acknowledgements

WethankthestaffofDepartmentofMedicalOncologyandDepartmentofClinicalResearch,

SunYat-SenUniversityCancerCenterfortheirconstructivesuggestions.Andwethankall

thepatientswhoparticipatedinthisstudy.

11

Conflictofinterest

Theauthorshavedeclarednoconflictsofinterest.

14

15

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5

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7

8

9

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15

18

1

Table1.Clinicalanddemographiccharacteristicsoflymphomaandhead/neck

2

cancerpatientsandclinicaltrialcharacteristics

Characteristics

Theradical

clinicalThepalliativeclinicalPvalue

trial,n(%)

Trial,n(%)

Age,years

＜60years

103(75.7)

72(82.8)

≥60years

33

(24.3)

15(17.2)

0.213

Gender

Male

95

(69.9)

70(80.5)

Female

41

(30.1)

17(19.5)

0.078

ECOGscore

0-1

134(98.5)

77(88.5)

2-3

2(1.5)

10(11.5)

0.001

Treatmentphase

Initialtreatment

71

(52.2)

23(26.4)

Retreatment

65

(47.8)

64(73.6)

0.001

Maritalstatus

Unmarried

12

(8.8)

4(4.6)

Married

124(91.2)

83(95.4)

0.139

Havekid

Yes

120(88.2)

83(95.4)

No

16

(11.8)

4(4.6)

0.068

Livingenvironment

Rural

40

(29.4)

19(21.8)

19

Town

34(25.0)

28

(32.2)

City

62(45.6)

40

(46.0)

0.344

Familyaddress

Outsideprovince

52(38.2)

27

(31.0)

Inprovince

84(61.8)

60

(69.0)

0.273

Education

Elementary

school

and

23(16.9)

18

(20.7)

below

Junior

high

school,

high

66(48.5)

50

(57.5)

school,specialsecondaryschool

Junior

college,university,

47(34.6)

19

(21.8)

0.127

andabove

Religion

Yes

20(14.7)

7(8.0)

No

116(85.3)

80

(92.0)

0.137

Annual

income/economic

status

≤50,000

104(76.5)

56

(64.4)

＞50,000

32(23.5)

31

(35.6)

0.050

Healthinsurance

Yes

59(43.4)

36

(41.4)

No

77(56.6)

51

(58.6)

0.783

Whetherornottherewas

freemedicine

Yes

110(80.9)

87

(100.0)

20

No

26(19.1)

0

(0.0)

0.001

Clinicaltrialstage

Stage1-2

14(10.3)

9

(10.3)

Stage3-4

122(89.7)

78(89.7)

0.990

1

2

3

21

Hopedtomakemedicalresearch

Table2.Differencesinperceptionsandattitudestowardclinicaltrialsoflymphoma

2 andhead/neckcancerpatients

Characteristics Theradicalclinical The palliative Pvalue

trial,n(%) clinicaltrial,n(%)

Hopedtotrynewmedication

Yes

90(66.2)

76

(87.4)

No

46(33.8)

11

(12.6)

<0.001

Hopedtoreceivefreemedication

Yes

87(64.0)

44

(50.6)

No

49(36.0)

43

(49.4)

0.047

Trustinthehospital

Yes

133(97.8)

87

(100.0)

No

3(2.2)

0(0.0)

0.163

Trustinthephysician

Yes

134(98.5)

86

(98.9)

No

2(1.5)

1(1.1)

0.839

Others'recommendation

Yes

44(32.4)

23

(26.4)

No

92(67.6)

64

(73.6)

0.347

Specialist'srecommendation

Yes

127(93.4)

86

(98.85)

No

9(6.62)

1(1.15)

0.054

acontribution

to

22

Yes

84(61.8)

60(69.0)

No

52(