Marilyn Kirshbaum|John Dent|John Stephenson|Annie Topping|Veronica Allinson|Megan McCoy|S. Brayford
Open access follow-up care for early breast cancer: a randomised controlled quality of life analysis
Charles Darwin University|Calderdale and Huddersfield NHS Foundation Trust|University of Huddersfield|Hamad Medical Corporation|Calderdale and Huddersfield NHS Foundation Trust|Breast Cancer Care|Breast Cancer Care
european journal cancer carevolume 26 issue 4 e12577 original articleopen access open access followup care early breast cancer randomised controlled quality life analysis n kirshbaum phd corresponding author n kirshbaum phd professor marilynnekirshbaumcdueduau school health faculty engineering health science environment charles darwin university darwin casuarina northern territory australia correspondence marilynne n kirshbaum school health faculty engineering health science environment charles darwin university darwin casuarina northern territory australia email marilynnekirshbaumcdueduausearch papers authorj dent md j dent md oncology consultant calderdale huddersfield nhs foundation trust huddersfield west yorkshire uksearch papers authorj stephenson phd j stephenson phd senior lecturer health sciences university huddersfield huddersfield uksearch papers authora e topping phd e topping phd professor assistant director nursing nurse education hamad medical corporation doha qaatarsearch papers authorv allinson msc v allinson msc advanced nurse practitioner calderdale huddersfield nhs foundation trust huddersfield west yorkshire uksearch papers authorm mccoy mccoy assistant director services regional national development breast cancer care sheffield uksearch papers authors brayford brayford uk wide service cocoordinator breast cancer care sheffield uksearch papers author n kirshbaum phd corresponding author n kirshbaum phd professor marilynnekirshbaumcdueduau school health faculty engineering health science environment charles darwin university darwin casuarina northern territory australia correspondence marilynne n kirshbaum school health faculty engineering health science environment charles darwin university darwin casuarina northern territory australia email marilynnekirshbaumcdueduausearch papers authorj dent md j dent md oncology consultant calderdale huddersfield nhs foundation trust huddersfield west yorkshire uksearch papers authorj stephenson phd j stephenson phd senior lecturer health sciences university huddersfield huddersfield uksearch papers authora e topping phd e topping phd professor assistant director nursing nurse education hamad medical corporation doha qaatarsearch papers authorv allinson msc v allinson msc advanced nurse practitioner calderdale huddersfield nhs foundation trust huddersfield west yorkshire uksearch papers authorm mccoy mccoy assistant director services regional national development breast cancer care sheffield uksearch papers authors brayford brayford uk wide service cocoordinator breast cancer care sheffield uksearch papers author first published 26 september 2016 httpsdoiorg101111ecc12577citations 23 funding information yorkshire cancer network breast cancer care university bradford huddersfield university calderdale huddersfield nhs trust report study compared acceptability open access supportive model followup care women treated stage 1 stage 2 breast cancer innovative model presented feasible alternative hospitalbased followup provides reassurance selfmanagement education prompt access health care practitioners required quality life indicators used evaluate demonstrate feasibility supported aboutsectionspdf toolsrequest permissionexport citationadd favoritestrack citation shareshare give accessshare full text accessshare fulltext accessplease review terms conditions use check box share fulltext version articlei read accept wiley online library terms conditions useshareable linkuse link share fulltext version article friends colleagues learn morecopy url share linkshare onfacebooktwitterlinkedinredditwechat abstract study evaluated acceptability supportive model followup one hundred twelve women recovering breast cancer randomised receive standard breast clinic aftercare control n 56 demand open access aftercare breast care nurses intervention n 56 participants attended supportbased psychoeducational programme delivered four halfday group sessions three quality life questionnaires eortc qlqc30 qlqbr23 hads administered baseline 6monthly intervals 2 years multilevel linear regression modelling methods used evaluation age found statistically significant predictor quality life several subscales increasing age negatively associated sexual functioning systematic therapy side effects physical functioning positively associated future perspective aftercare assignment found statistically significant predictor women treated early breast cancer disadvantaged allocation open access supportive care model terms quality life experienced model followup demonstrated feasible alternative routinised hospitalbased followup adds evidence stratified followup lowrisk cancer patients incorporating selfmanagement education stratified followup pathways viewed preferable approach 1 introduction main purpose routine followup care potentially curative treatment early breast cancer monitor local recurrence manage late effects treatment provide information support reassurance patients past many women treated breast cancer received hospital followup life time study current practice across yorkshire cancer network uk provide followup 5 years completion primary therapy women may attend 7 17 appointments period value resource intensive practice questioned many years beaver luker 2005 gulliford opomu wilson hanham epstein 1997 moschetti cinuini lambertini levaggi liberati 2016 taggart donnelly dunn 2012 acknowledged routine hospital visits asymptomatic breast cancer patients stressful patients serve clinical benefit apart providing platform annual mammography puglisi et al 2014 symptoms attributable local recurrence commonly identified patient interval clinic visits montgomery 2009 general practice moschetti et al 2016 yet practice regular followup breast clinics essentially well women become entrenched practice uk contributing health service burden potentially lengthening waiting times new referrals followup breast cancer care addressed national institute clinical guidelines nice 2009 early locally advanced breast cancer diagnosis treatment recommendation followup treatment discussed patients agreed care plan documented guideline proposed mammograms offered annually 5 years every 3 years age 50 part national screening programme nice 2009 indicated clinical followup could provided primary secondary shared care guideline major breakthrough added weight growing belief amongst health care practitioners routine hospital followup failed meet selfmanagement informational needs breast cancer patients ncsi 2013 nice 2009 value routine hospital followup medical surveillance primary objective finding treating local recurrence new breast cancers questioned unsurprisingly given lack evidence significantly improved survival outcomes palliation result early detection metastatic disease lifetime risk local recurrence previously treated breast lowrisk disease reported 1 year 1 increasing 5 years 3 4 wheeler stenning negus picken metcalfe 1999 indicated intensive early followup provided little clinical gain women likely relapse within time period clinical examination shown detect relatively relapses conserved breast lower sensitivity mammography geurts et al 2012 however risk contralateral breast cancer 35 times greater general population risk developing breast cancer risks endorse need form surveillance detect treat disease survival compromised interestingly majority local recurrences interval cancer identified hospital visits detected women churn kelly 2001 jack kerr kunkler 1998 unsurprisingly studies demonstrated many patients willing often take responsibility seeking medical attention event symptoms gulliford et al 1997 omahony hegarty mccarthy 2011 perspective healthcare professional women breast cancer primarily concerned recurrence yet many may information support needs coexist armes et al 2009 elliott et al 2011 khan mant carpenter forman rose 2011 addressed well armes et al 2009 reported 6 months 20 women five unmet needs frequently fear recurrence psychological nature evidence patients want access advice symptoms concerns preferably clinician know durifbruckert et al 2015 patients experiencing symptoms necessitating urgent assessment andor treatment also access systems providing rapid access specialist breast oncology services specialist nurses skilled providing information support successfully provided telephone followup services cancer patients provided triage assess manage new symptoms cox wilson 2003 koinberg fridlund engholm holmberg 2004 recently shewbridge et al 2014 evaluated delivery nurseled end treatment consultation clinic women completed treatment early breast cancer reported favourable outcomes nurses developing new consultation skills confidence addressing previously unmet patient needs patient acceptability women access support beyond scope nhs provision eg complementary therapies peer support patients national cancer charities breast cancer care macmillan cancer support also providing wellreceived information support services aid selfmanagement breast cancer care 2011 scanlon reed wray fenlon 2011 scanlon tilki 2006 potentially could formally incorporated copartners providing recovery package recommended national cancer survivorship initiative ncsi endorsed government policy recent national cancer strategy independent cancer taskforce cancer research uk 2015 identified need nhs service providers provide cancer patients easier access information posttreatment support available followup also intended provide psychological assessment support women recovering breast cancer psychological morbidities anxiety depression common patient group clinic attendances associated increased anxiety revisits feelings engendered diagnosis enhance concerns threat recurrence particularly share waiting room women active advanced disease king brooks featherstone topping 2014 health reassurance commonly offered main benefit patients derive checkups anxious patients may counterproductive stark et al 2004 goal many patients get back normal soon possible cancer treatment harvey 2009 clinical psychologist wealth experience working people cancer believes period recuperation convalescence rehabilitation needed first postulates normal life cancer diagnosis patients need learn new skills help cope changes acquisition skills could facilitated attendance structured psychoeducational selfmanagement programme company women similar stage treatment breast cancer care experience running moving forward courses aim educate women illness related effects addition learning selfmanagement skills need reassurance psychological support forms key element courses many clinicians recognise shortfalls current services reluctant reduce followup less 5 years various reasons given restructuring challenges required transition routine mammography service breast cancer population including clinician resistance followup care essentially screening moschetti et al 2016 offering opportunity monitor patients undergoing tamoxifen treatment currently 5 years initiate change speedily current practice changes andor new endocrine therapies recommended less resource intensive approaches monitoring would seem reasonable given availability acceptability specialist nurses information technology telephony systems support manage recall routine screening trigger alerts patients general practice recommendations regarding adjuvant hormonal therapies change evidence preference intensive minimalist followup among wellinformed women patients trials comparing different types followup tend express satisfaction allocation model likewise limited evidence regarding universal patient preference involvement decisionmaking treatments collins bekker dodwell 2004 although studies found patients increased involvement decisionmaking followup care reported better quality life andersen bowen morea stein baker 2009 andersen urban 1999 fallowfields 2001 work area indicated important patients understand participate clinicians decisionmaking process make treatment decisions concurs nice guidelines recommend patient specialist agree written followup care plan together part holistic needs assessment care plan locally agreed measures developed support womans transition unit ncsi 2010 risk recurrence associated stage disease diagnosis according breast cancer report cheung et al 2009 64 28462 invasive breast cancers diagnosed uk stage 17 stage ii 47 groups 5year survival rates 99 90 respectively followup practice could stratified according individual risk moreover would seem unreasonable offer women low risk earlystage disease alternative models followup whilst reserving hospital followup highrisk patients within context model followup based promoting supportive open access self management approach followup care developed regard previous work patients views needs 2 methods 21 aim design aim study test acceptability open access supportive care model followup women early lowrisk breast cancer embedded psychoeducational selfmanagement programme moving forward longitudinal singlecentre open randomised controlled design used measure detect trends quality life indicators 22 sample setting women newly diagnosed ajcc stage 1 stage 2 breast cancer treated curative intent considered clinically low risk recurrence invited participate study potential participants recruited breast cancer nurse following surgery staging possible prior planned radiotherapy treatment women excluded study stage 3 4 breast cancer receiving received adjuvant chemotherapy identified multidisciplinary team requiring followup due increased risk factors young age significant family history bilateral cancers taking part breast cancer clinical trials required followup per trial protocol informed consent obtained individual participants included study eligible women invited attend psychoeducational selfmanagement programme designed uk charity breast cancer care called living breast cancer known moving forward comprised halfday sessions delivered four consecutive weeks addressed topics included management breast cancer impact breast cancer breast reconstruction lymphoedema exercise breast awareness surgery healthy eating management menopausal symptoms programme originally designed breast cancer survivors aim enhancing health literacy selfconfidence supporting selfmanagement reducing isolation following attendance course women randomised one two groups 1 standard hospital aftercare control group 2 open access aftercare intervention group result nature intervention possible blind participants type aftercare received women intervention group routinely followedup provided resource pack designed complement course details access breast surgical services telephone helpline run breast cancer nurses experience breast cancer related concerns following open access supportive model followup patients care consultant usual duration appointment times setting 5 years time concerned worried patient return clinic immediately without gp referral diagnostic investigations booked problems resolved sooner reducing stressful waiting times starting treatment required minimal delay open access supportive model recognises role breast cancer nurse extended advanced practitioner able instigate investigations complete breast examinations biopsies gps informed patient attended course informed open appointments system works communications patient communicated gps patient mammography annually 5 years receive results post gps receive copy report 23 ethics statement procedures performed study involving human participants accordance ethical standards national research committee 1964 declaration helsinki later amendments comparable ethical standards study protocol approved national local ethics research panels informed consent obtained individual participants included study conflict interest linked authors associated study research conducted benefit lives breast cancer survivors without financial benefit authors 24 data collection three quality life questionnaires eortc quality life qlqc30 aaronson et al 1993 eortc qlqbr23 sprangers et al 1996 hospital anxiety depression scale hads zigmond snaith 1983 administered participant baseline t0 6 t1 12 t2 18 t3 24 months t4 first five questions qlqbr23 questionnaire relevant current analysis responses questions elicited participants 25 analysis questionnaires scored according qlq hads scoring manuals fayers aaronson bjordal curran bottomley 2001 qlqc30 questionnaire generates scores following functional scales global health status ql2 physical functioning pf2 role functioning rf2 emotional functioning ef cognitive functioning cf social functioning sf following symptom scales fatigue fa nausea vomiting nv pain pa dyspnoea dy insomnia sl appetite loss ap constipation co diarrhoea di financial difficulties fi questionnaire high scores functional subscales represent higher levels functioning low score symptom subscales represent higher level functioning qlqbr23 questionnaire generates scores following functional scales body image brbi sexual functioning brsef sexual enjoyment brsee future perspective brfu following symptom scales systematic therapy side effects brst breast symptoms brbs arm symptoms bras additional symptom scale upset hair loss brhl generated br23 questionnaire considered current analysis based questions br23 responses elicited questionnaire high scores functional subscales represent higher levels functioning low score symptom subscales represent higher level functioning hads questionnaire generated scores characteristics anxiety depression questionnaire low scores subscales represent higher levels functioning small proportion questions three questionnaires left unanswered data imputation undertaken following recommended methods questionnaire scoring manuals hence mean values imputed missing values scales response recorded least half items missing values imputed descriptive statistics means standard deviations calculated subscales considered subscale scores inspected individually presence trends multilevel model formulation utilised indicate relationships variables interest allow variation trends time different individuals model facilitates appropriate treatment variables patient measurementlevels total eight series models univariate multivariate derived hads scale series multivariate models derived using scores depression anxiety subscales hads instrument qlqbr23 questionnaire significantly lower number responses received brsef brsee subscales could imputed inclusion scale scores response variables may compromised accuracy multivariate model considering responses arising functional subscales hence subscales analysed individually series univariate models remaining functional subscales qlqbr23 questionnaire brbi brfu analysed series multivariate models three symptom subscales br23 questionnaire analysed together series multivariate models global health status subscale analysed individually series univariate models 5 functional scales excluding global health status subscale qlqc30 questionnaire analysed together series multivariate models nine symptom scales qlqc30 questionnaire analysed together series multivariate models 26 model selection strategy set outcome measures considered total 5 nested models derived null model including constant term explanatory variables model additionally including age covariate model additionally including grouping factor model including variables model including variables interaction model deviance likelihood ratio statistic determined statistically significant reduction deviance two nested models degrees freedom 1 2 approximate 2 distribution 12 degrees freedom taken indicative parameter remain model way likelihood ratio considerations determined five models associated set responses measures provided best summary data analyses performed using mlwin software version 225 using iterated generalised least squares igls procedure parameter estimation 3 results 31 descriptive summary data one hundred twelve women aged 296859 years baseline t0 recovering breast cancer recruited study fiftysix participants randomised control group 56 intervention group one participant failed complete baseline data recruitment 29 individuals lost followup baseline 24 months hence full set followup data received 82 patients 73 mean age patients control group baseline 605 years sd 979 years mean age patients intervention group baseline 607 years sd 1086 years means standard deviations transformed scores obtained subscales three questionnaires baseline 6 12 18 24 months given tables 13 table 1 hads questionnaire subscale scores mean sd control intervention groups subscale control group intervention group baseline 6 months 12 months 18 months 24 months baseline 6 months 12 months 18 months 24 months depressiona 353 345 358 370 359 403 346 318 394 412 319 272 299 289 344 309 373 339 371 324 anxietya 571 443 553 412 547 480 583 452 574 500 659 342 639 405 632 372 701 421 700 460 low score subscale represents higher level functioning table 2 qlqbr23 questionnaire subscale scores mean sd control intervention groups subscale control group intervention group baseline 6 months 12 months 18 months 24 months baseline 6 months 12 months 18 months 24 months brbia 757 286 738 312 770 303 790 272 804 262 787 211 820 167 805 209 820 203 794 259 brsefa 276 290 230 233 207 247 201 220 184 237 280 262 333 285 247 289 247 289 247 250 brseea 727 250 727 250 727 291 727 327 727 327 778 272 833 183 778 272 667 211 611 251 brfua 657 303 574 305 593 289 620 266 583 312 615 241 552 262 573 284 604 299 552 301 brstb 289 211 296 235 275 246 250 215 255 224 260 221 226 168 224 187 250 222 264 207 brbsb 209 183 168 189 155 225 134 168 93 112 232 202 172 146 154 181 126 137 115 128 brasb 133 182 154 227 145 236 111 161 154 208 145 143 118 159 121 153 108 153 120 150 bras arm symptoms brbi body image brbs breast symptoms brfu future perspective brsee sexual enjoyment brsef sexual functioning brst systematic therapy side effects high score subscale represents higher level functioning b low score subscale represents higher level functioning table 3 qlqc30 questionnaire subscale scores mean sd control intervention groups subscale control group intervention group baseline 6 months 12 months 18 months 24 months baseline 6 months 12 months 18 months 24 months ql2a 729 188 714 224 750 203 714 248 750 198 707 181 742 167 694 215 707 240 699 205 pf2a 861 140 854 171 872 130 863 147 861 153 865 175 865 170 847 179 857 207 867 193 rf2a 782 276 824 293 838 234 815 287 856 236 756 258 889 160 794 213 839 253 822 227 efa 779 177 788 242 783 256 788 225 754 274 758 179 761 204 775 244 755 224 753 248 cfa 795 249 765 285 791 270 803 209 803 244 785