D2.4 - STRONG AYA ethics report, with interim reports following ethics workshops

1 A new, in e disciplina y, mul i-s akeholde Eu opean ne wo k o imp o e heal hca e se ices, esea ch and ou comes o Adolescen s and Young Adul s wi h cance . STRONG-AYA – No. 101057482 – D2.4 2 Deli e able Repo WP2– Go e nance, Da a Secu i y and E hics Deli e able D2.4 STRONG AYA e hics epo , wi h in e im epo s ollowing e hics wo kshops Due da e o deli e able: 30/09/2023 Ac ual submission da e: 20/12/2023 P ojec : STRONG-AYA Lead Con ibu o S ephane Lejeune (EORTC) Email s ephane[email p o ec ed] O he Con ibu o s Emails Due da e 30 09 2023 Deli e y da e 20 12 2023 Deli e able ype R Dissemina ion le el PU Desc ip ion o Wo k Ve sion Da e Final e sion o epo a e app o al o ERAB V1.0 19/12/2023 STRONG-AYA – No. 101057482 – D2.4 3 Desc ip ion: STRONG - AYA E hics epo , wi h in e im epo s ollowing E hics wo kshops (yea 1) Publishable summa y (max ½ page) This deli e able is he epo o he i s mee ing (3 d No 2023) o he STRONG-AYA E hics and Regula o y Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on he e hics and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he conso ium. The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB mee s each yea oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou independen expe s and by he p ojec ep esen a i es who a ended he mee ing. STRONG-AYA – No. 101057482 – D2.4 4 1 Table o Con en s PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................... 3 1 TABLE OF CONTENTS .......................................................................................................................................... 4 2 DEFINITIONS....................................................................................................................................................... 5 3 ABBREVIATIONS ................................................................................................................................................. 6 4 INTRODUCTION .................................................................................................................................................. 7 PROJECT BACKGROUND ........................................................................................................................................... 7 DELIVERABLE INTRODUCTION .................................................................................................................................... 9 5 RESULTS ......................................................................................................... ERROR! BOOKMARK NOT DEFINED. 6 CONCLUSION .................................................................................................. ERROR! BOOKMARK NOT DEFINED. 7 REPOSITORY FOR PRIMARY DATA (ANNEX) .................................................... ERROR! BOOKMARK NOT DEFINED. STRONG-AYA – No. 101057482 – D2.4 5 2 De ini ions STRONG AYA conso ium membe s a e e e ed o as ollowing wi hin his ex : 1. NKI-AVL – S ich ing he Nede lands Kanke Ins i uu – An oni an Leeuwenhoek Ziekenhuis (NL) 2. YCE – You h Cance Eu ope (RO) 3. INT – Fondazione IRCCS Ins i u o Nazionale dei Tumo i (IT) 4. FFUND – FFUND BV (NL) 5. CLB – Cen e de Lu e Con e le Cance Leon Be a d (FR) 6. ECO – Eu opean Cance O ganisa ion (BE) 7. UNIMAAS – Uni e si ei Maas ich (NL) 8. IKNL – S ich ing In eg aal Kanke cen um Nede land (NL) 9. EORTC – Eu opean O ganisa ion o Resea ch and T ea men o Cance AISBL (BE) 10. IGR – Ins i u Gus a e Roussy (FR) 11. MSCNRIO – Na odowy Ins y u Onkologii im. Ma ii Sklodowskiej-Cu ie – Pans wowy Ins y u Badawczy (Ma ie Sklodowska-Cu ie Na ional Resea ch Ins i u e o Oncology) (PL) 12. UOM – Uni e si y o Manches e (UK) 13. UOL – Uni e si y o Leeds (UK) 14. LTHT – Leeds Teaching Hospi als Na ional Heal h Se ice T us (UL) 15. SOUTHAMPTON – Uni e si y o Sou hamp on (UK)  G an Ag eemen (including i s annexes and amendmen s): he ag eemen signed be ween he bene icia ies o he HORIZON Resea ch and Inno a ions Ac ions (he ea e e e ed o as Ho izon) and he Eu opean Heal h and Digi al Execu i e Agency (he ea e e e ed o as HADEA) o he unde aking o he STRONG AYA p ojec (G an Ag eemen no. 101057482).  Bene icia y: Signa o ies o he G an Ag eemen  Associa ed Pa ne : En i ies which pa icipa e in he ac ion bu wi hou he igh o cha ge cos s o claim con ibu ions.  P ojec : he sum o all ac i i ies ca ied ou in he amewo k o he G an Ag eemen .  Conso ium: he STRONG AYA conso ium, including all he a o emen ioned pa ne s.  Conso ium Ag eemen : The ag eemen made be ween STRONG AYA membe s o he implemen a ion and execu ion o he ac ion ou lined in he G an Ag eemen . The ag eemen shall no a ec he pa ies’ obliga ions o HADEA on behal o he Eu opean Union, and/o o one ano he a ising om he G an Ag eemen . STRONG-AYA – No. 101057482 – D2.4 6 3 Abb e ia ions Ac onym/Abb e ia ion Meaning HCP Heal h Ca e P o ide PRO Pa ien Repo ed Ou come PROM Pa ien Repo ed Ou come Measu e COS Co e Ou come Se WP Wo k Package WPL Wo k Package Lead(s) WP1 Wo k Package 1 (De elopmen Co e Ou come Se AYA wi h cance & da a collec ion) WP2 Wo k Package 2 (Go e nance, Da a Secu i y and E hics) WP3 Wo k Package 3 (In as uc u e and In e ope abili y) WP4 Wo k Package 4 (Ope a ion o STRONG AYA ecosys ems, s akeholde and pa ien in ol emen , dissemina ion, exploi a ion, communica ion) WP5 Wo k Package 5 (Scien i ic coo dina ion and p ojec managemen ) KPI Key Pe o mance Indica o OA Open Access PAB Pa ien Ad iso y Boa d EC Eu opean Commission HADEA Eu opean Heal h and Digi al Execu i e Agency SC S ee ing Commi ee MT Managemen Team ERAB E hics and Regula o y Ad iso y Commi ee STRONG-AYA – No. 101057482 – D2.4 7 4 In oduc ion P ojec backg ound Cance a adolescen and young adul (AYA) age is a e, al hough 4-6 imes mo e equen han paedia ic cance (i.e. p epubescen pe iod). Howe e , his a i y does no e lec he signi ican pe sonal and socie al cos s o cance in his popula ion, as e lec ed in he po en ial yea s o li e los o sa ed, he dec eased p oduc i i y and quali y-o -li e due o he impac o he disease du ing o ma i e yea s, and he long- e m complica ions o disabili ies1. AYAs wi h cance o m a unique g oup; hey ace age-speci ic issues (e.g. In e ili y, unemploymen , inancial p oblems) and dec eased quali y o li e due o cance and i s ea men . Unlike dedica ed heal hca e and ials o paedia ic cance pa ien s, AYA-speci ic heal hca e se ices a e sca ce and a y ac oss Eu ope. AYAs who a e a he co e o socie y and economy need access o age- app op ia e and high-quali y heal hca e. De ining AYAs wi h cance as 15 o 39 yea s a ini ial cance diagnosis2, hei annual cance incidence is 42.2/100.000, wi h 156.431 cases in Eu ope and 1.231.007 cases wo ldwide epo ed in 2018 ( oge he 6.8% o all cance s)3. Popula ion-based da a om 27 Eu opean coun ies suppo s ha AYAs ha e lowe su i al han child en bu highe han adul s a ec ed by cance . Ad ances in cance ea men ha e led o inc eased su i al a es o AYAs wi h cance , imp o ing by 82% o all cance s be ween 1990 and 20074. Howe e , su i al imp o emen in AYA is mo e challenging han o child en and olde cance su i o s, which migh be due o he ac ha AYA ha e he highes absolu e excess isk o second p ima y malignan neoplasms5. AYA ace some dis inc challenges gi en ha hey do no belong o nei he paedia ic no adul oncology g oups. Cha ac e is ic ea u es o his popula ion g oup include unique spec um o cance ypes, di e en umou biology, unique complex psychological needs, dis inc la e sequelae, including impai ed e ili y, and pallia i e ca e. These ai s imply ha clinical managemen , ea men , diagnosis, psychological suppo will need o be designed and de eloped o AYA’s speci ic needs. Fo example, AYAs diagnosed wi h b eas and p os a e ca cinomas ha e wo se su i al han olde pa ien s because o he biological di e ences be ween hem, highligh ing he need o a ge sc eening me hodologies, ea men and policies o hei needs6. AYAs wi h cance also ace signi ican psychological challenges, including subs ance abuse, men al heal h issues, suicidal idea ions and inc eased emo ional bu den om cance and cance - ela ed mo bidi y. Finally, ailo ing cance ca e o AYA’s needs is di icul and due o many di e en complex ac o s including he low a e o pa icipa ion by AYAs in clinical ials and cance esea ch7. Despi e he inc easing awa eness and a g owing body o he scien i ic li e a u e, hese unique issues emain o be ully ecognised and add essed by he Eu opean heal h sys ems and AYAs wi h cance a e equen ly unde se ed. In pa , his may ha e esul ed om he adi ional dicho omy be ween he in eg a ed paedia ic (“pa ien / amily-cen ed”) ca e se ices e sus dispe sed (“disease- cen e ed”) adul oncology 1 S oneham SJ. AYA su i o ship: The nex challenge. Cance 2020; 126: 2116-2119. 2 Adolescen and Young Adul Oncology Re iew G oup. Closing he gap: Resea ch and Ca e Impe a i es o Adolescen s and Young Adul s wi h Cance . Na ional Ins i u e o Heal h, Na ional Cance Ins i u e, and Li es ong Young Aul Alliance: Be hesda, MD, USA, 2006. 3 T ama A, Bo a L, S elia o a-Fouche E. Cance Bu den in Adolescen s and Young Adul s: A Re iew o Epidemiological E idence. Cance J 2018; 24: 256-266 4 T ama A, Bo a L, Foschi R e al. Su i al o Eu opean adolescen s and young adul s diagnosed wi h cance in 2000-07: popula ion-based da a om EUROCARE- 5. Lance Oncol 2016; 17: 896-906. 5 Keegan THM, Bleye A, Rosenbe g AS e al. Second P ima y Malignan Neoplasms and Su i al in Adolescen and Young Adul Cance Su i o s. JAMA Oncol 2017; 3: 1554-1557. 6 S a k D, Bielack S, B ugie es L e al. Teenage s and young adul s wi h cance in Eu ope: om na ional p og ammes o a Eu opean in eg a ed coo dina ed p ojec . Eu opean Jou nal o Cance Ca e, 25(3), 419–427. 7 Hayashi RJ. Adolescen and young adul cance su i o ship: The new on ie o in es iga ion. Cance 2019; 125: 1976-1978. STRONG-AYA – No. 101057482 – D2.4 8 se ices8,9,10. Up o hal o AYAs wi h cance epo unme in o ma ional and se ice needs, impac ing hei di ec (su i al a es) and indi ec (long e m e ec s and men al heal h) eco e y o pa icipa e in socie y11. Fu he mo e, aligned wi h his ba ie is he low a e o heal h ca e u ilisa ion by AYAs, especially p ima y ca e, gi en hei challenges o sus ain heal h insu ance co e age12. Acco ding o a su ey conduc ed h ough he ne wo ks o he AYA Wo king G oup o he Eu opean Socie y o Medical Oncology (ESMO) and he Eu opean Socie y o Paedia ic Oncology (SIOP Eu ope), 67% o p ac i ione s do no ha e access o specialised cen es o AYA wi h cance , 67% had no access o a specialis cance se ice o la e e ec s managemen and 38% had no access o e ili y specialis s. Unde -p o ision and inequali y o AYA cance ca e is common ac oss Eu ope and especially in he Eas e n and Sou he n-Eas . Fu he mo e, he Wo king G oup also epo ed an absence o ou come measu es o moni o ing and e alua ing AYA cance ca e p og ams and con ol13. Among he ecommended u u e s eps, i has been iden i ied ha one o he mos impo an con ibu ions o AYA esea ch would be o pool da a (e.g. pa ien - epo ed ou comes, clinical and ea men da a) ac oss ins i u ions and coun ies and c ea e la ge coho s o esea che s o Add ess he bu den o cance in AYA14. The e is a lack o da a s anda diza ion, da a in e ope abili y and (p ospec i e) collec ion o ou comes o ele ance o AYAs wi h cance . The STRONG-AYA p ojec aims o ackle he unde ep esen a ion o AYA’s expe iences and ou comes when na iga ing he heal hca e sys em and in clinical ca e by de eloping na ional in as uc u es o ou come da a managemen and clinical decision-making wi hin a pan-Eu opean ecosys em and es ablishing communica ion eedback o AYAs wi h cance and he heal hca e sys ems. This will be key o imp o ing heal hca e se ices, esea ch, ou comes and policies o AYAs and o ul ima ely be e cance ca e o his pa ien g oup. To his aim, STRONG-AYA b ings oge he an in e na ional mul i-disciplina y conso ium ac oss se en Eu opean coun ies, led by he Ne he lands Cance Ins i u e (NKI) and composed o academic esea ch o ganisa ions (Eu opean O ganisa ion o Resea ch and T ea men o Cance (EORTC), Uni e si y o Sou hamp on, Uni e si y o Leeds, Uni e si y o Manches e , Maas ich Uni e si y, Ne he lands Comp ehensi e Cance O ganisa ion (IKNL)), clinical pa ne s (I alian Na ional Tumou Ins i u e, Léon Bé a d Cen e, Gus a e Roussy Ins i u e, Ma ia Sklodowska-Cu ie Na ional Resea ch Ins i u e o Oncology, he Leeds Teaching Hospi als Na ional Heal h Se ice T us ), s akeholde and pa ien o ganisa ions (You h Cance Eu ope, Eu opean Cance O ganisa ion) and a consul ing company (FFUND). Building on p e ious ini ia i es, a STRONG-AYA da a ecosys em will be se up o alue-based ca e, esea ch and policy o AYA wi h cance by: 1. De eloping a Co e Ou come Se (COS) speci ically o AYAs wi h cance , ia a pa icipa i e consensus p ocess de ining mos impo an aspec s o hose di ec ly a ec ed by AYA cance , including pa ien s and heal hca e p o essionals. 8 Fe a i A, S a k D, Pecca o i FA e al. Adolescen s and young adul s (AYA) wi h cance : a posi ion pape om he AYA Wo king G oup o he Eu opean Socie y o Medical Oncology (ESMO) and he Eu opean Socie y o Paedia ic Oncology (SIOPE). ESMO Open 2021; 6: 100096. 9 Osbo n M, Johnson R, Thompson K e al. Models o ca e o adolescen and young adul cance p og ams. Pedia Blood Cance 2019; 66: e27991. 10 Fa dell JE, Pa e son P, Wake ield CE e al. A Na a i e Re iew o Models o Ca e o Adolescen s and Young Adul s wi h Cance : Ba ie s and Recommenda ions. J Adolesc Young Adul Oncol 2018; 7: 148-152. 11 Keegan TH, Lich ensz ajn DY, Ka o I e al. Unme adolescen and young adul cance su i o s in o ma ion and se ice needs: a popula ion-based cance egis y s udy. J Cance Su i 2012; 6: 239-250. 12 Hayashi RJ. Adolescen and young adul cance su i o ship: The new on ie o in es iga ion. Cance 2019; 125: 1976-1978. 13 Salous os E, S a k D, Michailidou K e al. Repo on ESMO/SIOPE Eu opean Landscape p ojec key esul s: Mapping he s a us and needs in AYA cance ca e. La e-b eaking and de e ed publica ion abs ac s public heal h 2017; 28, 5: V643. 14 Smi h AW, Seibel NL, Lewis DR e al. Nex s eps o adolescen and young adul oncology wo kshop: An upda e on p og ess and ecommenda ions o he u u e. Cance 2016; 122: 988-999. STRONG-AYA – No. 101057482 – D2.4 9 2. Implemen ing he COS ac oss se e al na ional Eu opean heal hca e sys ems. Da a will be collec ed a local le el and will hen be included in a da a in eg a ion pla o m. An o e all ecosys em amewo k o da a analy ics and ou pu will be c ea ed suppo ing ede a ed analyses and he c ea ion o epo s ac oss clinical and pa ien - epo ed da a and making na ional eposi o ies o (pa ien - epo ed) heal h da a, a ailable o indi idual pa ien s, pa ien o ganisa ions, egula o y au ho i ies, as well as he pa ien s’ heal h ca e p o ide s o in o m clinical decision-making. The i e esul ing na ional ecosys ems will be connec ed o each o he in o he pan-Eu opean ecosys em using a ede a ed app oach also u ilizing he o e all ecosys em amewo k. 3. Dissemina ing he COS o a wide ange o local as well as pan-Eu opean s akeholde s, in pa icula by de eloping analy ical ools o p ocess and p esen pa ien ou come da a and es ablish eedback loops ha in o m pa ien s and clinicians. Implemen ing hese p ojec objec i es a e i e wo k packages wi hin he STRONG-AYA p ojec :  WP1: De elopmen Co e Ou come Se AYA wi h cance and Da a Collec ion (Lead: SOUTHAMPTON)  WP2: Go e nance, Da a Secu i y and E hics (Lead: EORTC)  WP3: In as uc u e and In e ope abili y (Lead: UNIMAAS)  WP4: Ope a ion o STRONG-AYA ecosys ems, S akeholde and Pa ien in ol emen , Dissemina ion, Exploi a ion, Communica ion (Lead: E.C.O.)  WP5: Scien i ic Coo dina ion and P ojec Managemen (Lead: NKI) STRONG-AYA will enable AYA ca e and esea ch o bene i om collec ion and pooling o pa ien -cen e ed da a and collabo a ion among all s akeholde s: pa ien s, heal hca e p o essionals, scien is s, and policymake s. Mo e widely, he p ojec will le e age he ne wo k o in e es ed o ganisa ions and ne wo ks es ablished unde STRONG-AYA o long- e m s eng hened p omo ion o he necessa y implemen a ion o specialis AYA cance se ices ac oss Eu ope. This will ul ima ely b ing no el insigh s in o AYA cance ca e, esea ch and policy, con ibu ing o he long- e m imp o emen o ou comes o people wi h AYA cance . Deli e able in oduc ion This deli e able is he epo o he i s mee ing (3 d No 2023) o he STRONG-AYA E hics and Regula o y Ad iso y Boa d (ERAB). The ERAB aims o p o ide he conso ium wi h an independen iew on he e hics and legal challenges as well as he mi iga ion ac ions planned o al eady implemen ed by he conso ium. The ERAB is composed o ou independen expe s in e hics and/o legal aspec s. The ERAB mee s each yea oge he wi h conso ium ep esen a i es. This epo has been app o ed by he ou independen expe s and by he p ojec ep esen a i es who a ended he mee ing. 5 STRONG-AYA E hics and Regula o y Ad iso y Boa d (ERAB) - Repo o he 1s Mee ing ( i ual), 3 No embe 2023 A endees: - ERAB membe s  F ancesco Ta a, UK  F ancis P. C awley, BE  Ma hias B aun, DE