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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
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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
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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
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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
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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
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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
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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
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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
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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