biron - birkbeck institutional research online version of bmjopen paper for biron.pdf ·...
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BIROn - Birkbeck Institutional Research Online
Grunfeld, Elizabeth and Schumacher, L. and Armaou, M. and Woods, P.L.and Rolf, P. and Sutton, A.J. and Zarkar, A. and Sadhra, S.S. (2018) Afeasibility randomized controlled trial of a guided workbook intervention tosupport work-related goals among cancer survivors in the UK. BMJ Open ,ISSN 2044-6055. (In Press)
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Afeasibilityrandomizedcontrolledtrialofaguidedworkbookinterventionto
supportwork-relatedgoalsamongcancersurvivorsintheUK
ElizabethAGrunfeld1,LaurenSchumacher2,MariaArmaou2,PernilleLWoods1,PaulineRolf2,
AndrewJSutton3,AnjaliZarkar4,StevenSSadhra5
1DepartmentofPsychologicalSciences,BirkbeckCollege,London,UnitedKingdom
2FacultyofHealthandLifeSciences,CoventryUniversity,Coventry,UnitedKingdom
3LeedsInstituteofHealthSciences,UniversityofLeeds,Leeds,UnitedKingdom
4OncologyDepartment,QueenElizabethHospital,UniversityHospitalsBirminghamNationalHealth
ServiceFoundationTrust,Birmingham,UnitedKingdom
5OccupationalandEnvironmentalMedicine,InstituteofClinicalSciences,CollegeofMedicaland
DentalSciences,UniversityofBirmingham,Birmingham,UnitedKingdom
CorrespondingAuthor
ElizabethAGrunfeld,DepartmentofPsychologicalSciences,BirkbeckCollege,MaletStreet,London,
UnitedKingdom
2
Abstract
Objectives:Employmentfollowingillnessisassociatedwithbetterphysicalandpsychological
functioning.Thisstudyaimedtoassessthefeasibilityandacceptabilityofatheoretically-led
workbookinterventiondesignedtosupportcancerpatientsreturningtowork.
Design:Parallel-grouprandomizedcontrolledtrialwithembeddedqualitativeinterviews
Setting:OncologyclinicswithinfourEnglishNationalHealthServiceTrusts
Participants:Patientswhohadreceivedadiagnosisofbreast,gynecological,prostateorcolorectal
cancerandwhowereatleast2weekspost-treatmentinitiation.
Intervention:Aself-guidedWorkPlanworkbookdesignedtosupportcancerpatientstoreturnto
workwithfortnightlytelephonesupportcallstodiscussprogress.Thecontrolgroupreceived
treatmentasusual,andwereofferedtheworkbookattheendoftheir12-monthfollow-up.
Outcomemeasures:Weassessedaspectsoffeasibilityincludingeligibility,recruitment,data
collection,attrition,feasibilityofthemethodology,acceptabilityoftheinterventionandpotentialto
calculatecost-effectiveness.
Results:Therecruitmentrateofeligiblepatientswas44%;68participantsconsentedand58(85%)
completedbaselinemeasures.Randomizationprocedureswereacceptable,datacollectionmethods
(includingcost-effectivenessdata)werefeasibleandtheinterventionwasacceptabletoparticipants.
Retentionratesatsixand12monthsfollow-upwere72%and69%respectively.At6-monthfollow-
up30%oftheusualcaregrouphadreturnedtofullorpart-timework(includingphasedreturnto
work)comparedto43%oftheinterventiongroup.At12-monthsthepercentageswere47%(usual
care)and68%(intervention).
Conclusions:Thefindingsconfirmthefeasibilityofadefinitivetrial,althoughfurtherconsideration
needstobegiventoincreasingtheparticipationratesamongmenandBlackandethnicminority
patientsdiagnosedwithcancer.
Trialregistration:InternationalStandardRandomizedControlledTrialNumber(ISRCTN):
ISRCTN56342476
Strengthsandlimitationsofthisstudy
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• Thestudyassessedthefeasibilityandacceptabilityofarandomizedcontrolledtrial(RCT)ofa
theory-ledinterventiontosupportreturntoworkamongpatientswithadiagnosisofbreast,
gynecological,colorectalorprostatecancer.
• Theinterventionusedaworkbookformatcomprisingofpaper-basedexercisesandthe
developmentofareturntoworkplan.
• Amixedmethoddesign,withnestedqualitativeinterviews,wasusedtoassesstheacceptability
oftheintervention,thefeasibilityoftheRCTandtodeterminetheutilityofthepatientreported
outcomemeasures(PROMS).
• Onlyfourcancertypeswereincluded,whichmaylimitgeneralizability.
• Viewsofmaleparticipants,aswellasBlackandethnicminorityparticipants,wereunder
represented,asthemajorityofparticipantswerefemaleandCaucasianandallwereEnglish
speaking.
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Introduction
Almosthalfofadultcancersurvivorsareofworkingage1,yetcancerpatientsare1.4timesmore
likelytobeunemployedthanhealthyindividuals2.Cancerpatientsmayexperienceongoingnegative
outcomesfromthediseaseortreatment(includingpain,fatigue,andlowmood)thatcanimpact
everydayfunctioning,includingwork3,4.Returntoworkratesvaryacrosscancertypes5,however,
longerreturntoworktimesareassociatedwithcertaintreatments(e.g.chemotherapy6),fatigue7,or
anon-supportiveworkenvironment8.Predictorsofreturntoworkincludeoptimalsymptom
management(asoveraquarterofcancersurvivorsreporthighsymptomburdenone-yearpost-
diagnosis,evenaftertheendoftreatment9),implementingappropriateworkplaceadaptations,as
wellasspecificcancer(i.e.beliefsabouttheconsequencesofcancer)andtreatment-related
perceptions(i.e.beliefsaboutcontrollingtheeffectsofcanceratwork).
Employmentisimportantnotonlyforindividualfinancialandsocietaleconomicreasons10but
becausebeingoutofworkisthoughttocontributeto,andaggravate,adversehealthoutcomes1,11.
Returningtoandstayinginworkfollowingillnessisassociatedwithbetterphysicalandpsychological
functioning.Notworkingisassociatedwithreducedself-esteem,loweredself-efficacy,and
decreasedbeliefinone'sabilitytoreturntotheworkplace12.Furthermore,workisanimportant
componentofqualityoflife13andimpairedworkisassociatedwithincreaseddepressionand
anxietyamongcancerpatients14.
Severalinterventionstosupportworkinghavebeendevelopedacrossillnessgroups,including
musculoskeletaldisorders,backpainandmultiplesclerosis.Theseinterventionshavetendedto
focusonergonomicadaptationwithintheworkplacewiththeaimofminimisingtheriskofphysical
injuries,likelytobeexperiencedbythesepatientgroups.Interventionstargetedatcancerpatients
includea12-weekoccupationalphysician-ledinterventionfocusedonincreasingphysicalactivityto
supportreturntowork15;acasemanagementapproachinvolvingsignposting/referringpatientsto
services(e.g.physiotherapy,occupationalorpsychologicaltherapy)tosupportreturntowork16;and
atoolthatcancersurvivorsusetoguidediscussionsaboutworking17.However,thistoolfocusedon
interactionswithemployersandhealthcareprofessionalsandnotonpatients’beliefsandbarriers
thatimpactworkability(one’sperceptionofone’sabilitytowork)andinfluenceworkbehaviour.
Furthermore,aCochranereviewreportedlowqualityevidenceforreturntoworkratesforpsycho-
educationalinterventions(interventionsthatencompassabroadrangeofactivitiesthatcombine
educationalandotheractivitiessuchascounsellingandsupportivecare),howeverthiswasbasedon
onlytwostudies;onewhichfocusedonteachingself-carebehaviourstomanagefatigueandone
comprisinglecturesfocusedonside-effects,stressandcoping.Thereviewconcludedthattherewas
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aneedformorehigh-qualityrandomizedcontrolledtrials(RCTs)18.Furthermore,ameta-synthesis
ofqualitativeresearchstudieshighlightedtheneedforvocationalinterventionswithcancerpatients
tobeperson-centredandforsuchinterventionstoacknowledgetheroleofsocial,clinical,andwork-
relatedfactors19.
TheWorkPlaninterventionistheoreticallyledandutilisestheself-regulationmodel20andgoal
settingtheory21.WorkPlanwasdevelopedfollowingtheMRCguidelinesforthedevelopmentof
complexinterventions22andutilisedaninterventionmappingmethodologyfordesigningand
implementingcomplexinterventionsorprograms.WorkPlandiffersfromotherpublished
interventionsinthatitsupportspeoplediagnosedwithcancertoprepareforreturningtoworkby
creatingaspacetoenvisageandconstructafutureatwork,thensupportingpatientstodevelop
appropriatecommunicationandplanningskillstosupportreturningtowork.Theworkbook
comprisesactivitiesaimedatelicitingbeliefsabouttheimpactofcancerandoftheperson’s
perceivedworkability,identifyingactionstofacilitatetheprocessofreturningtoworkandto
supportspecifictasksoncewithintheworkplace.Theindividualthenoutlinesconcretestepsto
achievetheirgoalsthroughastructuredreturntoworkplan.
Aims
TheprimaryobjectiveofthestudywastotrialtheWorkPlaninterventionanddatacollection
materialstodetermineifthematerialswereacceptabletoparticipantsandwhetherparticipants
wereabletoprovidefullanswers.Theaimswereto:
(1)identifywhetherthematerialsandinterventionwereacceptableandunderstandable
(2)determinewhethertherecruitmenttargetwasachievableandidentifythemostsuccessful
methodsofrecruitment
(3)determinetheacceptabilityoftherandomizationprocess
(4)identifyretentionratesinbotharms
(5)determineifdatawereobtainabletoenableafullcost-effectivenessanalysisinadefinitivetrial
Methods
Afulldescriptionoftheprotocolisavailableelsewhere23.
Participants
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Thetargetwastorecruit60participants(30randomizedintoeachgroup).Thiswasnotahypothesis
testingtrialandthesamplesizewasbasedonpragmaticassumptionsaroundfeasiblerecruitment
figuresandthenumberofparticipantsrequiredtoestimatethekeyparametersaroundthe
feasibilityofafullRCT.
Inclusioncriteria:(a)receivedadiagnosisbreast,gynaecological,prostateorcolorectalcancer;(b)
hadnotbeenclassifiedashavingmetastaticdiseaseorrecurrence;(c)atleast2weekspost-
treatmentinitiation;(d)aged18to70years;(e)workingatthetimeofdiagnosis;(f)andnotworking
attimeofrecruitmentbutintendedtoreturntowork.
Recruitmentandrandomisation
ParticipantswererecruitedbyresearchersandresearchnursesthroughfourEnglishNationalHealth
ServiceTrustsUK.Participantswereidentifiedthroughcancerclinics,multidisciplinaryteam
meetings,andbyplacingpostersandleafletsinclinics,supportandinformationservices,
chemotherapysuites,andcomputerizedtomographyscanwaitingareas.Allrecruitmentsiteswere
basedintertiarycarecentres.Inaddition,collaboratingclinicianswereprovidedwithleafletsand
informationpacksoutliningthestudy.Wetranslatedrecruitmentmaterialsintothefivemost
commonlyspokenlanguagesamongpeopleofworkingageinBirmingham(2011Census):Bengali,
Chinese(standard),Polish,Punjabi,andUrdu.Fundingwasavailabletoprovideinterpretersif
requiredandwewereabletotranslatetheworkbookintodifferentlanguagesifrequiredby
participants.Potentialparticipantswhoexpressedinterestinthestudywereprovidedwithastudy
informationsheetandaskedtoprovidetheircontactdetailsfortheresearchertophoneand
confirmiftheywereinterestedinparticipating.Eligibleparticipantswhoexpressedaninterestin
participationwerescreenedoverthephoneandweresentaninvitationforanassessmentinterview
(whichincludedanexplanationoftherandomizationprocess)atthehospitaloroverthetelephone.
Allparticipantswererequiredtoprovidewrittenconsenttoparticipate.
Followingtheassessmentinterviewtheresearchersutilisedanonlineandtext-basedrandomization
system(SealedEnvelopeLtd)torandomizeparticipantsataratioof1:1betweentheintervention
groupandusualcaregroup.Participantswerestratifiedbyage(18-50yearsor51andover)and
cancertype(breast,bowel,gynaecological,orurological).Participantswhoconsentedintothestudy
wereloggedaccordingtorecruitmentsiteusingtheNationalInstituteforHealth’s(NIHR)Central
PortfolioManagementSystem.
Intervention
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TheWorkPlanpackage isa4-weekguidedworkbook interventionconsistingofstructuredsections
and activities to provide guidance and support to patients. The workbook is broken down into
chapters. Chapter one focused on thinking about illness and treatment (based around the illness
perceptions component of the Self-Regulation Model) and includes causes of cancer, symptoms,
beliefs about efficacy of treatment and consequences of living as a survivor of cancer. It then
explores the participant’s beliefs about the impact of cancer and treatment on their ability to
function in the workplace, including suggestions for management. The chapter concludes by
examiningparticipants’emotionalreactionstotreatmentandsupport/strategiestomanagethese.
Chapter two is focused on setting and achieving goals (based on Goal Theory) including the goal
settingprocess, identifyingandovercomingbarriersandutilising support.Chapter threeworkson
building confidence, including ways to boost confidence. This chapter concludes by examining
fatigue andways to to identify andmanage fatigue triggers. Chapter 4 focuses on developing an
action plan for returning to work and outlines how to initiate discussions and deal with difficult
questionswithintheworkplace.
Participantswereencouragedtoworkthroughchaptersinturnduringeachweekoftheintervention
period, allocating around 120 minutes per week. However, this was not strictly monitored and
participantshadtheopportunity towork throughthe interventionatapacethatsuitedthemand
their timeframe for returning towork. Participants incorporated all elements from theworkbook
into a personal return toworkplan,which theywere encouraged todevelop in the finalweek.A
resources section signposted participants toward relevant avenues of further support. Multiple
copiesofthereturntoworkplanningpagewereavailabletoencouragechangestobemadewhen
necessary, and these plans were used as a tool when meeting with employers to aid discussion
aroundreturningtowork.Serviceusersintheoriginalpilotwork(ofthematerialsandstudydesign)
wereconcernedaboutraisingwork-relatedissuestooearlywiththeiremployerandstatedthatthey
would prefer to engage with their workplace after completing the intervention, when they felt
better able to represent their view and had formed a return to work plan. Therefore, the
interventiondoesnothaveaspecificemployercomponentbutrathertheworkbookpromotesskills
toenablecommunicationwithemployers.
Controlgroup
Participantsreceivedusualcare,whichfocusedonclinicalcareandoptimalsymptommanagement.
Inordertopreventparticipantsfromundertakingactivitiesintheworkbooktheinformationsheets
andpre-randomizationdiscussiondidnotincludethecontentorfocusoftheinterventionand
participantswerenotofferedtheworkbookuntilaftertheir12-monthfollow-up.
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Participantsinbothgroupswereabletoaccessotherinformationandsupportrelatingtoworkand
werethereforeaskedtorecordanyresourcesorinformationtheyutilisedduringthetrial.
Studyoutcomes
Primaryoutcome
Theprimaryoutcomesweretimetoreturntoworkandreturntoworkratesat6and12month
follow-ups.Anychangesinworkingstatuse.g.contractedhoursanddutiesweredocumentedalong
withspecificreasonsfornon-returntowork(e.g.,unavailabilityofjob,ongoingmedicalconcerns)to
determinewhethertoincorporatespecificreasonsfornon-returnasmeasuresinafulltrial.
Secondaryoutcomes
Secondaryoutcomemeasuresincludedmood,satisfactionwithreturntowork,andsatisfactionwith
thereturntoworkprocess.
Datawascollectedat4timepoints:baseline(T0),4weekspost-intervention(interventiongroup)or
4weekspost-randomisation(usualcaregroup)(T1),and6-monthpostrandomisation(T2)and12-
monthpost-randomisation(T3)follow-ups.Ateachtimepointparticipantsweremaileda
questionnairepack(withaprepaidself-addressedenvelope)thatcomprised:(1)IllnessPerceptions
Questionnaire-Revised24;(2)BriefIllnessPerceptionatWorkScale25;(3)HospitalAnxietyand
DepressionScale26;(4)WorkAbilityIndex27;(5)Satisfactionwithreturntoworkifreturnedtowork
(singleitem);(6)SatisfactionwithWorkScale28(ifreturnedtowork);(7)EQ-5D-5L(QualityofLife)29;
(8)VisualAnalogueScalemeasureofQualityofLife(singleitem)30.
Workstatusandhealthcareutilization
Participantsprovideddetailsoftheiruseofservicesandemploymentactivityviatextmessage(using
JANET;http://www.pageone.co.uk/services/janet-txt).Amaximumoffourtextmessagesweresent
toparticipantsattheendofeachmonthtogatherinformationontheirworkstatus(i.e.full-time,
part-time,phasedreturn,sickleave,notworking),numberofdaysworkedthatmonthand
healthcareutilization(numberofgeneralpractitionerappointmentsthatmonth).Monthlyintervals
werechosenasmemoryofgeneralpractitionerappointmentsisaround4weeks,sowecouldnot
relyonaccuraterecallofhealthcareutilizationat6-monthquestionnairefollow-ups31,32.
Adverseevents
Arecordsheetwasproducedfortherecordingofadverseeventsandprovidedaspartofthestudy
filetoallparticipatingsites.Ifparticipantsreportedanynegativeevents,includinglowmoodor
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anxiety,asaresultoftakingpartinthestudyorundertakingtheintervention,orifparticipants
withdrewfromthestudyduetoanadverseeventthenthiswererecordedontherecordsheet.
Qualitativeinterviews
Theaimofthepost-interventionand12-monthfollow-upinterviewswastobetterunderstandthe
effectsoftheinterventionandtoexplorehowtheinterventionwasexperiencedbyparticipants.
Participantswereapproachedsequentiallyuntiltherecruitmenttargetwasreached.Interviews
wereconductedoverthetelephoneorfacetoface,dependingontheparticipant'spreference.The
post-randomizationinterviewfocusedon(1)beliefsaboutworkandcancer(2)experienceof
employmentandworkvalues;and(3)waysinwhichreturningtoworkcouldbesupportedand(4)
expectationsoftheWorkPlanintervention.Twelve-monthinterviewsexplored(1)beliefsabout
cancerandworkandhowthesewerechallengedovertheprecedingyear,(2)generalperceptionsof
thetrial,and(3)thepersonalreturntoworkprocessofeachindividual.
Dataanalysis
Descriptivestatisticsforallbetweengroupoutcomemeasuresarepresented,includingmeans(SD),
andfrequencies.Thepurposeofthisfeasibilitystudywasnothypothesistestingandthesamplesize
wasunderpoweredtoundertakethefullanalysisthatwouldbeusedinafulltrial(analysisof
covarianceadjustingforbaselinevalues).
Economicanalysis
Althoughaneconomicevaluationwasnotsuitableinthecontextofafeasibilitytrial,wedidaimto
determinewhetherdatawouldbeobtainabletoenableafullcost-effectivenessanalysisina
definitivetrial.
Qualitativedata
Interviewswereaudiorecorded,transcribedverbatim,andanalysedusingtheframeworkmethod
[46]toidentifyemergentthemes.Theconsolidatedcriteriaforreportingqualitativeresearch
(COREQ)wereusedtoguidethepresentationofthequalitativeanalyses.Findingsfromthe
quantitativeandqualitativeanalysesarepresentedconcurrentlyalthoughfullerdetailsofthe
methodologyfortheinterviewsandofthequalitativefindingshavebeenreportedelsewhere33.
Patientandpublicinvolvement
TheWorkPlaninterventionwasdevelopedfollowingaprospectivestudy,whichfollowedcancer
patientsforoneyearfollowingtheendoftreatmenttoidentifyfactorsthatinfluencedthelikelihood
10
ofnotreturningtowork.TheWorkPlaninterventionwasthenrefinedwithinputfrom15cancer
survivorswhoprovidedfeedbackonthecontentandwordingoftheworkbookandformatof
delivery(workbookorfacetofacesessions).Onesteeringgroupmemberandauthor(PR)wasa
patientrepresentativeandprovidedinputonrecruitment,studydesignandmaterials.Study
participantswereaskediftheywouldlikealaysummaryofthestudyfindingsattheendofthestudy
andthiswassenttoallwhoindicatedthattheywould.
Results
Eligibilityandrecruitment
Duringtherecruitmentperiod324patientswereidentifiedandassessedforeligibilityand170
participantswereineligible(reasonsincludednotworkingattimeofdiagnosis,olderthan70years
oralreadyreturnedtowork).Afurther154patientswereconsideredeligible(Figure1).Eighty-sixof
theseparticipantsdeclinedtoparticipateresultingin68participants(44%)beingconsentedand
randomisedintothestudy.Although68participantsconsentedtotakepartinthestudyonly58
returnedfullycompletedT0(baseline)questionnaires.Therewasnodifferencebetweenthosewho
returnedthequestionnairesandthosewhodidnotonanyofthedemographicorclinicalmeasures,
siteofrecruitment,sizeofemployer,orrandomizedgroup.Intheinterviewsparticipantsreported
thattherandomizationprocesswasacceptable.
Furthermore,23participantsintheinterventiongroupwereinterviewedatthepost-intervention
(T1)time-point,whichexceededourtargetof20.Atthe12-month(T3)follow-up22participants
fromtheinterventiongroupand20fromthecontrolgroupparticipatedinaninterview,which
exceededourtargetof40participantsintotal.
Samplecharacteristics
Wewereunabletocollectdemographicinformationofparticipantswhochosenottoconsentinto
thestudy.Themajorityofparticipantsself-identifiedasbeingWhite(88%);followedby
African/Afro-Caribbean(7%)andAsian(5%)(Table1).Therewassignificantlymorewoman(79%)
thanmen(21%)recruitedintothestudy.Thisreflectedthelargepercentageoftheparticipantswho
hadbeendiagnosedwithbreastcancer(50%)andgynaecologicalcancers(15%)comparedto
prostate(16%)andcolorectal(19%).Themajorityofparticipantsweremarriedorlivingwitha
partner(71%)andhalfwereeducatedtodegreelevelofabove(50%).Comorbidities(definedasany
concurrentdiagnosisofaphysicalorpsychologicaldisorderforwhichparticipantswerecurrently
receivingtreatment)weremorecommonamongtheusualcare(50%reportingoneormore
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comorbidities)thantheinterventiongroup(29%)andthiscouldbeexploredinafuturetrialasa
possiblemediatorofreturningtowork.
Datacollection
Attrition
Attritionrates(determinedbynonreturnofthequestionnaireatthattime-point)frompointof
randomisationtoonemonth(T1),sixmonths(T2)and12months(T3)follow-upwere24.5%(29%in
interventionand20%incontrolgroup),28%(29%ininterventionand27%incontrolgroup)and31%
respectively(32%ininterventionand30%incontrolgroup).Thiswasslightlyhigherthanthe
conservative25%estimatewehadforecastat12months.Attritionwashigherwhenparticipants
wererecruitedintothetrialbyresearchnurses(37%atT3)ratherthanthestudyresearchassistants
(19%atT3),potentiallyindicatingthatparticipantsaremorelikelytoremaininastudywhenthey
haddevelopedarelationship(throughtheinformationandconsentprocess)witharesearcheron
theproject.
Acceptabilityoftheoutcomemeasuresanddatacollectionmethods
Forthemostpart,theoutcomemeasureswereacceptableandnoparticipantsraisedstudyburden
asaconcernduringtheinterviews.Participantswhoreturnedthequestionnairesateachtime-point
mostlyreturnedfullycompletedquestionnairesanddidnotsystematicallyleavequestions
unanswered.Wetrialledusingatext-baseddatacollectionsystemforcollectingmonthlyworkdata
andGPvisits.Thiswasacceptabletothemajorityofparticipants;onlytwoparticipantsdidnothave
accesstoamobilephoneandsoweusedmonthlyemailstocollectthisdatawiththeseparticipants.
Adverseevents
Noadverseeventswerereportedduringthefeasibilitytrial.
Participantsviewsoftheintervention
Fromtheinterviews,itwasapparentthatoverallparticipantsenjoyedtakingpartintheintervention
andthatitprovidedafocusandclarityregardingtheprocessofreturningtoworkandoptionsthat
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theymightconsider.Theworkbookwasdescribedasausefultoolthatfacilitatedtheplanning
processforreturningtoworkandthattheexerciseswithintheworkbook“brokeit[theprocess]
downintosmallbits”.Itallowedparticipantstoimaginethepotentialproblemsaroundroles,tasks
andeventsthatcouldariseandplanhowtodealwiththese.Furthermore,byconsidering
interactionsintheworkplace,suchascopingwithco-workers’reactions,theywereabletoengagein
mentalroleplaytorehearsehowtorespond,gainingconfidenceinmanagingasuccessfulreturnto
work.
Theworkbookformatoftheinterventionwaswellreceivedbyparticipantsandpreferredbythe
majorityofparticipantstotheideaofusinganonlineorappversion.Thebookletwasseenas
convenient(easytoaccesscomparedtoanonlineversion),simpletotransportandcouldeasilybe
sharedwithothers.
Ithinkthebenefitofdoingthebookletwithapeninyourhandisthatyouactuallyfeelmore
engagedwithit.You’rewritingitandyou’rephysicallyowningyourwords.Whereasonthe
computerIthinkitwouldbealotmoreimpersonal(P24,aged54)
I’vebeenabletogotobedandI’vebeenabletoreadit.Withmyphoneit’ssmall,doyou
knowwhatImean?Thingscouldbemissed.Ifit’sabookwhereyoucomebacktoitnowand
again.It’sthereatthesideofmybedandkindofpromptsyoutodoit.(P10,aged44)
However,aminorityofintervieweesdidsuggestthatitwouldbemoresecure(requiringapassword)
andenvironmentallyfriendlytohaveanonlineversion.
Althoughtheinterventionwasperceivedasusefulsomeintervieweesdidhighlightareasthatcould
eitherhavebeenmoredetailedinthebookletorthathadnotbeenincluded.Themainareawhere
participantsrequiredgreaterdetailwasaboutmanagingfinancesduringsickleaveperiodsand
aboutfinancialsupportthatcouldbeavailabletothem.Thisisanareaofthecurrentintervention
thatwouldneedtobeadaptedbeforemovingtoafulltrial.Furthermore,duringtheinterviewsone
participantcommentedonthewordingofthebooklet,whichreferredtopatientshavingcompleted
treatment,whereasthepatientwasstillgoingthroughtreatmentandthismadeitdifficultforthem
toengagesuggestingthatthebookletmightneedrewording.
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Iwasstilltryingtogothroughtreatmentanditwastalkingabouttheprocesswhenithadall
finished.Iwasstillgoingthroughtreatment,soIrememberbeingquiteannoyedaboutthat
(P15).
Outcomesmeasures
Theprimaryoutcomesweretimetoreturntoworkandreturntoworkratesat6and12month
follow-ups.Therewerenosignificantdifferencesbetweentheusualcareandinterventiongroupin
termsofthenumberofdaysfromleavingworktoreturningtowork(usualcaremean308days(SD
74)comparedtointerventionmeanof333days(SD153)).Thegreaternumberofdaysobservedfor
theinterventiongroupwaslikelyinfluencedbythefactthatwithintheinterventiongroup(mean
190days,SD145)therewereagreaternumberofdays(non-significant)betweenleavingand
consentingintothestudy(sothisgrouphadalreadybeenoutofworkforalongerperiodoftime)
comparedtotheusualcaregroup(mean158days,SD100).Althoughtheinterventiongroup
reportedagreaternumberofdaysworkedpermonthat6and12-monthfollow-up(Table2),these
didnotreachsignificance,possiblyduetolackofpower.Inaddition,at6-monthfollow-up30%of
participantsintheusualcaregrouphadreturnedtofullorpart-timeworkcomparedto43%ofthe
interventiongroup.At12months,thepercentageswere47%(usualcare)and68%(intervention).
Regardingsecondaryoutcomemeasures,theinterventiongroupreportedlessanxietyand
depression-relatedsymptomsalthoughthesedidnotreachsignificanceandwouldneedtobe
examinedaspartofafullypoweredRCT.TherewaspotentiallyaflooreffectwiththeEQ-5D(health
status)withfewsymptomsreportedateachtime-point,resultinginlowscoresacrossparticipants
withlimiteddispersionofthescores.
Discussion
ThisstudyaimedtoassessthefeasibilityandacceptabilityofanRCTofaworkbookinterventionto
supportcancerpatientsinreturningtowork.Ourresultsindicatethattheformatoftheworkbook
waswellreceivedandthattheexerciseswithintheworkbookwereengagingandusefulinthe
returntoworkprocess.However,itshouldbenotedthatthismaybeaconsequenceof
acquiescencebiasorlackofawarenessoftheutilityofanalternativetoformatusedwithinthetrial.
Anunexpectedoutcomewasthedegreetowhichparticipantsvaluedtheprocessofwritingwithina
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physicalworkbook.Theworkbookaidedtheminorganisingtheirthoughts,enablingthemtoplanfor
thefuture.Expressivewriting,ortheformationofawrittennarrativeexploringtheemotional
aspectsofapersonalexperience,allowsanindividualtoorganiseownthoughtsandemotionsintoa
coherentnarrative,orsummary,thatcanfacilitatemoreeffectivecoping34,35.UsingtheWorkPlan
workbookwasnotintendedtoactasanexpressivewritingtask,however,itenabledparticipantsto
explorethoughtsandemotionsrelatedtotheircancerandtoworkandtheworkenvironment
includingorganisational(support,shiftpatterns)aspectsoftheirwork;aprocesswhichparticipants
identifiedasbothsupportiveandenjoyable.Thereisaclearneedforanintervention,suchas
WorkPlan,tosupportpatientsinplanningtheirreturntoworkandtosupporttheminthinking
abouthowtheycouldovercomepotentialissuesassociatedwithworktasks,theirrole
(responsibilities)aswellaccommodatingongoingmedicalcareandtreatment(i.e.fittingwork
requirementsaroundmedicalconsultationsandtreatment).
Therecruitmentratewas44%,whichwasacceptableandin-linewithotherstudies.However,there
werefewermenrecruited(21%)thanwehadexpected,whichwasdueinparttothecancertypes
thatwerecruitedintothestudywithtwo-thirdsofparticipantshavingbeendiagnosedwithbreast
orgynaecologicalcancers.Inafuturetrial,wewouldwidentherangeofcancertypesthatwouldbe
eligibleforinclusionandstratifybygenderaswellasage.Themajorityofparticipantsalsoidentified
asbeingWhite(88%),however,withintheBirminghamarea(wherethemajorityofrecruitmenttook
place)around81%ofthepopulationwereclassifiedasWhite36andthereforethefindingsmaynot
berepresentativeofcancerpatientsreturningtoworkaftertreatment.Afuturetrialwillneedto
makemaleandminorityrecruitmentapriorityandrecruitmentmaterialsmayneedamendingtobe
morerelevanttothesegroups37.Inaddition,althoughwetranslatedrecruitmentmaterialsintofive
languagestosupportrecruitmentofnon-Englishspeakersintothestudywewereunsuccessfulin
recruitinganynon-Englishspeakers.However,themainbarriertorecruitingnon-Englishspeakers
wasnotnecessarilyalanguagebarrierbutratherthatthatthemajorityofthoseapproachedwere
notworkingatthetimeofdiagnosis.Finally,halfofstudyparticipantswereeducatedtodegreelevel
and,althoughthisisin-linewithnumbersofschoolleaversenteringtertiaryeducationintheUK
today,itishigherthanwouldhavebeenobservedamongtheagegroupsincludedinthisstudyand
thereforefurtherworkisneededtounderstandthereasonforlowuptakeintothestudyofpeople
leavingeducationatanearlierage.
15
Overall,thestudydesign,usinganestedqualitativeevaluation,wasfoundtobefeasible. Akeystrengthofthisstudywasthemixed-methodsapproach,whichallowedfortriangulationof
experiencesoftheparticipants.Qualitativemethodsprovideddepthofunderstandingandthe
findings,particularlyexplorationoftrialacceptability,suggestedthatparticipantsweregenerally
satisfiedwiththeprocessandfoundtheexperienceacceptableandinformative.However,patients
mayhavebeeninclinedtoproducesociallydesirableresponses,althoughwithattritionrateswithin
tolerablelimitsthereisadditionalsupportfortheacceptabilityofthestudyprocess.Finally,the
insightsemergingfromthisstudyreliedonin-depthqualitativeinvestigation,however,itshouldbe
notedthatthefindingsarelimitedtopredominatelyfemale,Caucasianparticipants.
Thiswasafeasibilitystudyandsoefficacytestingwasnotanaimofthestudyandthesmallsample
sizewaslikelyinsufficienttodetectsubtledifferencesbetweengroups.Theprimaryoutcome
measureswerereturntoworkratesat6and12monthfollow-upsandinafuturetrialwewouldalso
usethetextbaseddatacollectionsystemtocollectinformationaboutactualreturntoworkdate.
Determiningtheeconomiccostoftheinterventionisimportantgiventhatalthoughthereisstrong
evidenceofreturntoworkinterventionsprovidingcostsavingsfromasocietalperspectivethereisa
needtoensurethatactualinterventioncostswouldbemanageableoncetheinterventionwas
implemented38.Theoutcomesforuseinaneconomicanalysisinafulltrialwerefoundtobe
feasibleandacceptable.Inparticular,thetoolforcollectingdataonworkbehaviourandGP
attendancewassuccessful,andtheburdenonparticipantsdidnotappeartobeexcessive.Ina
futuretrialwewouldalsocollectinformationaboutadditionalservicesthatwereutilised(e.g.outof
hoursprimarycareservices,minorinjuryunitsandcounsellingservices),thenumberofhours/days
ofworkthataremissed(inthistrialwecollecteddataonthenumberofdaysworked),asthese
couldcontributetosocietalcosts.Furthermore,theaimofthestudywastoexplorethefeasibilityof
undertakinganRCToftheWorkPlaninterventionandthis,alongwiththesmallsamplesize,meant
thatwedidnotexaminetheroleofsocioeconomicfactorsortypeofemploymentasamediatorof
returningtoworkineachofthegroups.However,thisdata(includingjobtitleandpostcode)was
collectedandcouldbeutilisedinafuturetrial.
Followingonfromthefindingsofthefeasibilitystudythereareanumberofadaptationsproposed
forafuturestudy.AlimitationofthecurrentstudyisthattheviewsofBlackandethnicminority
groupsareunder-represented.Therecruitmentmaterialsandhowpatientsareidentifiedand
approachedwillneedrefiningtoincreasethenumberofmenandBlackandethnicminority
16
participants.Attritionwashigheramongparticipantsrecruitedfromsiteswithresearchnurses
ratherthansiteswherethestudyresearchassistantsrecruited,whichmaybepartlyduetorapport
andknowledgeoftheproject,bothofwhichhavebeenreportedtoimpactrecruitment39.To
improveretention,particularlyfromsiteswheretheparticipantsarenotrecruitedbythestudy
researchassistants,thereneedstobegreaterefforttobuildrapportwithparticipantsand
encourageretentioninthetrial.Inaddition,althoughweusedincentivestoencourageparticipation
(includinga£20voucherforcompletingtheassessmentinterview)itmaybethatgreater
considerationneedstobegiventocompensatingparticipantsfortheirtimethroughoutthe12-
monthstudy.Afurtherlimitationisthatthestudydidnotincludetheviewsandexperiencesof
employers,whomayholdnegativebeliefsabouttheabilityofcancersurvivorstoreturntowork25
andthereforeimpactontheprocessofreturningtowork.Finally,althoughweexamined
engagementandacceptabilityoftheintervention(throughtheinterviews)wedidnottestthe
fidelityoftheinterventionaspartofthisfeasibilitytrial.Therefore,inafullRCTwewould
systematicallyassessinterventionfidelityand,wherepossible,incorporatefidelitydatainthe
analysisofoutcomes40.
Conclusion
ThisstudyinvestigatedthefeasibilityofundertakinganRCTofaworkbookbasedinterventionto
supportcancerpatientsinreturningtotheworkplace.Theinitialresultsareencouragingand
suggestthattheinterventionwasbothwellreceivedandconveyedbenefittoparticipantsin
supportingreturntoworkaftercancertreatment.Thefindingssuggestthat,withminor
modifications,aneffectivenessRCTiswarranted.
Contributors
EAGconceivedtheideaforthestudy.EAG,AJS,SSScontributedtothestudydesign,randomizationandanalysisplan.EAGwrotethefirstdraft.LS,MA,PLW,PR,AJS,AZ,SSSwereinvolvedinmultiplerevisions.Thefinalversionofthemanuscriptwasapprovedbyallco-authors.
Fundingstatement:ThisworkwassupportedbytheNationalInstituteforHealthResearch(ResearchforPatientBenefitProgramme)grantnumberPB-PG-0613-31088.
TheviewsexpressedarethoseoftheauthorsandnotnecessarilythoseoftheNHS,theNIHRortheDepartmentofHealth.
17
Competinginterests
Theauthorsdeclarethattheyhavenocompetinginterests
Ethicsapproval:EthicalapprovalforthisstudywasobtainedfromtheNationalResearchEthicsService(Reference:15/WM/0166)andresearchgovernanceapprovalwasobtainedfromallfourparticipatingNHSTrusts.
Datasharingstatement:Additionalunpublisheddataarenotpubliclyavailable.
18
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Figurelegends
Figure1:Flowofparticipantsthroughthestudy(showingcumulativeattritionateachtime-pointfrompointofrandomization)
Excluded(n=256) Notmeetinginclusioncriteria(n=170) Declinedtoparticipate(n=86)
Assessedforeligibility(n=324)
Intervention(n=34) Non-response:(n=3)
Allocatedtointervention(n=38)
UsualCare(n=24) Losttofollow-up(n=6)
Allocatedtousualcare(n=30)
Randomisation
T0(Baseline)
Randomized(n=68)44%ofeligibleparticipants
Intervention(n=27) Non-response(n=6)PatientWithdrew(n=1)
UsualCare(n=24) T1(1Month)
T2(6Months) Intervention(n=27) UsualCare(n=22) PatientDied:(n=1);Non-response(n=1)
Intervention(n=26) PatientWithdrew:(n=1)
UsualCare(n=21) PatientDied:(n=1);Non-response:(n=1)
T3(12Months)
Withdrew(n=1)(n=37)
23
Table1.ParticipantDemographics
Usualcare(n=30)
Interventiongroup(n=38)
All(n=68)
Age,mean(range)
51.2(35-63) 50.4(25-65) 50.8(25-65)
Gendern(%) Female Male
26(87)4(13)
28(74)10(26)
54(79)14(21)
MaritalStatusn(%) MarriedorLivingwithPartner DivorcedorSeparated SingleandNeverMarried
20(67)6(20)4(13)
28(74)6(16)4(10)
48(71)12(18)8(11)
Dependentchildrenlivingathomen(%)
13(43) 13(34) 26(38)
Ethnicityn(%)WhiteAsianAfrican/Afro-Caribbean
25(83)2(8.5)2(8.5)
35(90)
1(3)3(7)
60(88)
3(5)5(7)
Highesteducationleveln(%)DidnotcompletesecondaryeducationSecondaryeducation(to16years)Furthereducation(to18years)Highereducation(degreeorhigher)
0(0)
14(47)3(10)
13(43)
1(3)
9(24)7(18)
21(55)
1(1)
23(34)10(15)34(50)
CancerDiagnosisn(%) Breast Urological Bowel Gynaecological
16(53)
2(7)7(23)5(17)
18(46)9(24)6(16)5(14)
34(50)11(16)13(19)10(15)
Comorbiditiesn(%)123ormore
8(27)1(3)
6(20)
8(21)0(0)
5(13)
16(24)
1(1)11(16)
Flexibleworkingallowedn(%)
7(23) 18(48) 25(37)
Numberofmonthsentitledtofullsickpay;mean(SD)
3.9(2.7) 4.8(3.2) 4.4(2.9)
Workstatusat6monthfollow-upn(%) Workingfull/parttime*
9(30)
16(43)
25(37)
Workstatusat12monthfollow-upn(%) Workingfull/parttime*
14(47)
26(68)
40(59)
*Includingphasedreturntowork
24
Table2Outcomemeasuresbyassessmenttimepointandgroup
Studygroup T0baselinemean(SD)
T1postinterventionmean(SD)
T26-monthfollow-upmean(SD)
T312monthfollow-upmean(SD)
Emotion(IPQ-R) Usualcare 2.7(0.6) 2.6(0.7) 2.4(0.5) 2.6(0.6)Intervention 2.9(0.6) 2.6(0.7) 2.6(0.5) 2.7(0.7)
Timeline(IPQ-R) Usualcare 3.3(0.1) 3.3(0.6) 3.1(0.5) 3.0(0.5)Intervention 2.9(0.1) 3.1(0.7) 3.1(0.6) 3.0(0.8)
Illnesscoherence(IPQ-R) Usualcare 3.3(0.5) 3.3(0.6) 3.4(0.6) 3.5(0.6)Intervention 3.1(0.7) 3.1(0.7) 3.1(0.7) 3.2(0.8)
Illnessconsequences(IPQ-R) Usualcare 3.9(0.7) 3.9(0.5) 3.9(0.3) 3.9(0.3)Intervention 3.9(0.7) 4.0(0.4) 3.8(0.4) 3.9(0.4)
Personalcontrol(IPQ-R) Usualcare 3.4(0.8) 3.4(0.4) 3.4(0.4) 3.2(0.4)Intervention 3.3(0.8) 3.3(0.6) 3.3(0.4) 3.2(0.7)
Treatmentcontrol(IPQ-R) Usualcare 3.5(0.4) 3.5(0.4) 3.5(0.4) 3.4(0.4)Intervention 3.5(0.4) 3.4(0.4) 3.5(0.3) 3.5(0.4)
Briefillnessperceptionatworkscale
Usualcare 3.6(0.5) 3.7(0.9) 3.6(0.9) 3.4(0.5)Intervention 4.0(0.9) 3.6(0.7) 3.4(1.1) 3.6(0.9)
EQ-5D-5L(healthstatus) Usualcare 2.1(0.1) 1.8(0.6) 1.7(0.5) 1.6(0.5)Intervention 1.7(0.8) 1.6(0.5) 1.6(0.4) 1.5(0.4)
Visualanaloguescalemeasureofqualityoflife
Usualcare 56.2(18.7) 59.3(20.7) 71.6(17.9) 75.0(19.5)Intervention 61.6(19.3) 68.0(22.6) 73.7(14.7) 77.8(17.1)
Anxiety(HADS) Usualcare 8.3(4.3) 7.9(4.4) 7.2(4.5) 6.7(3.4)Intervention 7.2(4.3) 7.3(4.5) 6.3(3.5) 6.1(4.2)
Depression(HADS) Usualcare 5.8(3.0) 5.0(3.8) 4.9(3.6) 4.5(4.3)Intervention 6.1(4.1) 5.6(4.2) 4.7(3.5) 3.9(3.1)
Workabilityindex(overall) Usualcare 4.3(0.7) 4.4(3.1) 6.7(2.8) 7.6(2.6)Intervention 2.7(0.5) 5.4(3.7) 6.6(3.4) 7.8(3.0)
Workabilityindex(physicaldemandsofrole)
Usualcare 2.5(0.3) 2.8(1.1) 3.2(1.0) 3.8(1.0)Intervention 2.3(0.5) 3.2(1.2) 3.3(1.3) 3.9(1.2)
Workabilityindex(cognitivedemandsofrole)
Usualcare 2.7(0.2) 2.9(1.2) 3.1(1.3) 3.7(1.2)Intervention 2.5(0.2) 3.0(1.3) 3.2(1.2) 3.9(1.2)
Satisfactionwithworkscale Usualcare 3.7(0.7) 3.5(0.6) 3.5(0.7) 3.4(0.6)Intervention 3.4(0.9) 3.3(1.0) 3.3(1.1) 3.3(1.0)
Numberofdaysworkedthatmonth
Usualcare - 3.5(7.7) 5.7(8.7) 11.5(10.1)Intervention - 3.4(6.5) 8.9(9.2) 12.4(7.9)