D4.5 - Leaflets explaining outcomes in lay terms

1 A new, interdisciplinary, multi-stakeholder European network to improve healthcare services, research and outcomes for Adolescents and Young Adults with cancer. STRONG-AYA – No. 101057482 – D4.5 2 Deliverable Report WP4 – Operation of STRONG AYA ecosystems, stakeholder and patient involvement, dissemination, exploitation, communication Deliverable D4.5 Leaflets explaining outcomes in lay terms Due date of deliverable: 31/12/2023 (pending amendment approval) Actual submission date: 11/01/2023 Project: STRONG-AYA Lead Contributor Urska Kosir (YCE) Email Other Contributors Tomaž Deželak (PAB member) Mariana Coutinho (PAB member) Ana Amariutei (PAB member) Erik Sturesson (PAB member) Nicola Unterecker (PAB member) Florin Barnea (PAB member) Emails Due date 31 12 2023 Delivery date 21 12 2023 Deliverable type R Dissemination level PU Description of Work Version Date STRONG-AYA – No. 101057482 – D4.5 3 V1.0 21/12/2023 Description: Training material for PAB members to enable their informed participation in decisions on indicator selection and interpreting outcome findings Publishable summary (max ½ page) The attached pamphlet is a training tool developed by the STRONG AYA Patient Advisory Board (PAB members) to inform their understanding of the STRONG AYA project and its outcomes for the duration of the project. As co-creation is an integral part of the project’s ethos, the PAB was involved, alongside the work package leads, in the creation of their training pamphlets. These pamphlets can serve a dual use in educating various stakeholders on the project in general. STRONG-AYA – No. 101057482 – D4.5 4 1 Table of Contents 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 – D4.5 5 2 Definitions STRONG AYA consortium members are referred to as following within this text: 1. NKI-AVL – Stichting het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NL) 2. YCE – Youth Cancer Europe (RO) 3. INT – Fondazione IRCCS Instituto Nazionale dei Tumori (IT) 4. FFUND – FFUND BV (NL) 5. CLB – Centre de Lutte Contre le Cancer Leon Berard (FR) 6. ECO – European Cancer Organisation (BE) 7. UNIMAAS – Universiteit Maastricht (NL) 8. IKNL – Stichting Integraal Kankercentrum Nederland (NL) 9. EORTC – European Organisation for Research and Treatment of Cancer AISBL (BE) 10. IGR – Institut Gustave Roussy (FR) 11. MSCNRIO – Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie – Panstwowy Instytut Badawczy (Marie Sklodowska-Curie National Research Institute of Oncology) (PL) 12. UOM – University of Manchester (UK) 13. UOL – University of Leeds (UK) 14. LTHT – Leeds Teaching Hospitals National Health Service Trust (UL) 15. SOUTHAMPTON – University of Southampton (UK)  Grant Agreement (including its annexes and amendments): the agreement signed between the beneficiaries of the HORIZON Research and Innovations Actions (hereafter referred to as Horizon) and the European Health and Digital Executive Agency (hereafter referred to as HADEA) for the undertaking of the STRONG AYA project (Grant Agreement no. 101057482).  Beneficiary: Signatories of the Grant Agreement  Associated Partner: Entities which participate in the action but without the right to charge costs or claim contributions.  Project: the sum of all activities carried out in the framework of the Grant Agreement.  Consortium: the STRONG AYA consortium, including all the aforementioned partners.  Consortium Agreement: The agreement made between STRONG AYA members for the implementation and execution of the action outlined in the Grant Agreement. The agreement shall not affect the parties’ obligations to HADEA on behalf of the European Union, and/or to one another arising from the Grant Agreement. STRONG-AYA – No. 101057482 – D4.5 6 3 Abbreviations Acronym/Abbreviation Meaning HCP Health Care Provider PRO Patient Reported Outcome PROM Patient Reported Outcome Measure COS Core Outcome Set WP Work Package WPL Work Package Lead(s) WP1 Work Package 1 (Development Core Outcome Set AYA with cancer & data collection) WP2 Work Package 2 (Governance, Data Security and Ethics) WP3 Work Package 3 (Infrastructure and Interoperability) WP4 Work Package 4 (Operation of STRONG AYA ecosystems, stakeholder and patient involvement, dissemination, exploitation, communication) WP5 Work Package 5 (Scientific coordination and project management) PAB Patient Advisory Board EC European Commission HADEA European Health and Digital Executive Agency STRONG-AYA – No. 101057482 – D4.5 7 4 Introduction Project background Cancer at adolescent and young adult (AYA) age is rare, although 4-6 times more frequent than paediatric cancer (i.e. prepubescent period). However, this rarity does not reflect the significant personal and societal costs of cancer in this population, as reflected in the potential years of life lost or saved, the decreased productivity and quality-of-life due to the impact of the disease during formative years, and the long-term complications or disabilities1. AYAs with cancer form a unique group; they face age-specific issues (e.g. Infertility, unemployment, financial problems) and decreased quality of life due to cancer and its treatment. Unlike dedicated healthcare and trials for paediatric cancer patients, AYA-specific healthcare services are scarce and vary across Europe. AYAs who are at the core of society and economy need access to ageappropriate and high-quality healthcare. Defining AYAs with cancer as 15 to 39 years at initial cancer diagnosis2, their annual cancer incidence is 42.2/100.000, with 156.431 cases in Europe and 1.231.007 cases worldwide reported in 2018 (together 6.8% of all cancers)3. Population-based data from 27 European countries supports that AYAs have lower survival than children but higher than adults affected by cancer. Advances in cancer treatment have led to increased survival rates for AYAs with cancer, improving by 82% for all cancers between 1990 and 20074. However, survival improvement in AYA is more challenging than for children and older cancer survivors, which might be due to the fact that AYA have the highest absolute excess risk of second primary malignant neoplasms5. AYA face some distinct challenges given that they do not belong to neither paediatric nor adult oncology groups. Characteristic features of this population group include unique spectrum of cancer types, different tumour biology, unique complex psychological needs, distinct late sequelae, including impaired fertility, and palliative care. These traits imply that clinical management, treatment, diagnosis, psychological support will need to be designed and developed for AYA’s specific needs. For example, AYAs diagnosed with breast and prostate carcinomas have worse survival than older patients because of the biological differences between them, highlighting the need to target screening methodologies, treatment and policies to their needs6. AYAs with cancer also face significant psychological challenges, including substance abuse, mental health issues, suicidal ideations and increased emotional burden from cancer and cancer-related morbidity. Finally, tailoring cancer care to AYA’s needs is difficult and due to many different complex factors including the low rate of participation by AYAs in clinical trials and cancer research7. Despite the increasing awareness and a growing body of the scientific literature, these unique issues remain to be fully recognised and addressed by the European health systems and AYAs with cancer are frequently underserved. In part, this may have resulted from the traditional dichotomy between the integrated paediatric (“patient/family-centred”) care services versus dispersed (“diseasecentered”) adult oncology 1 Stoneham SJ. AYA survivorship: The next challenge. Cancer 2020; 126: 2116-2119. 2 Adolescent and Young Adult Oncology Review Group. Closing the gap: Research and Care Imperatives for Adolescents and Young Adults with Cancer. National Institute of Health, National Cancer Institute, and Livestrong Young Ault Alliance: Bethesda, MD, USA, 2006. 3 Trama A, Botta L, Steliarova-Foucher E. Cancer Burden in Adolescents and Young Adults: A Review of Epidemiological Evidence. Cancer J 2018; 24: 256-266 4 Trama A, Botta L, Foschi R et al. Survival of European adolescents and young adults diagnosed with cancer in 2000-07: population-based data from EUROCARE5. Lancet Oncol 2016; 17: 896-906. 5 Keegan THM, Bleyer A, Rosenberg AS et al. Second Primary Malignant Neoplasms and Survival in Adolescent and Young Adult Cancer Survivors. JAMA Oncol 2017; 3: 1554-1557. 6 Stark D, Bielack S, Brugieres L et al. Teenagers and young adults with cancer in Europe: from national programmes to a European integrated coordinated project. European Journal of Cancer Care, 25(3), 419–427. 7 Hayashi RJ. Adolescent and young adult cancer survivorship: The new frontier for investigation. Cancer 2019; 125: 1976-1978. STRONG-AYA – No. 101057482 – D4.5 8 services8,9,10. Up to half of AYAs with cancer report unmet informational and service needs, impacting their direct (survival rates) and indirect (long term effects and mental health) recovery to participate in society11. Furthermore, aligned with this barrier is the low rate of health care utilisation by AYAs, especially primary care, given their challenges to sustain health insurance coverage12. According to a survey conducted through the networks of the AYA Working Group of the European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOP Europe), 67% of practitioners do not have access to specialised centres for AYA with cancer, 67% had no access to a specialist cancer service for late effects management and 38% had no access to fertility specialists. Under-provision and inequality of AYA cancer care is common across Europe and especially in the Eastern and Southern-East. Furthermore, the Working Group also reported an absence of outcome measures for monitoring and evaluating AYA cancer care programs and control13. Among the recommended future steps, it has been identified that one of the most important contributions to AYA research would be to pool data (e.g. patient-reported outcomes, clinical and treatment data) across institutions and countries and create large cohorts for researchers to Address the burden of cancer in AYA14. There is a lack of data standardization, data interoperability and (prospective) collection of outcomes of relevance for AYAs with cancer. The STRONG-AYA project aims to tackle the underrepresentation of AYA’s experiences and outcomes when navigating the healthcare system and in clinical care by developing national infrastructures for outcome data management and clinical decision-making within a pan-European ecosystem and establishing communication feedback for AYAs with cancer and the healthcare systems. This will be key to improving healthcare services, research, outcomes and policies for AYAs and to ultimately better cancer care for this patient group. To this aim, STRONG-AYA brings together an international multi-disciplinary consortium across seven European countries, led by the Netherlands Cancer Institute (NKI) and composed of academic research organisations (European Organisation for Research and Treatment of Cancer (EORTC), University of Southampton, University of Leeds, University of Manchester, Maastricht University, Netherlands Comprehensive Cancer Organisation (IKNL)), clinical partners (Italian National Tumour Institute, Léon Bérard Centre, Gustave Roussy Institute, Maria Sklodowska-Curie National Research Institute of Oncology, the Leeds Teaching Hospitals National Health Service Trust), stakeholder and patient organisations (Youth Cancer Europe, European Cancer Organisation) and a consulting company (FFUND). Building on previous initiatives, a STRONG-AYA data ecosystem will be set up for value-based care, research and policy for AYA with cancer by: 1. Developing a Core Outcome Set (COS) specifically for AYAs with cancer, via a participative consensus process defining most important aspects for those directly affected by AYA cancer, including patients and healthcare professionals. 8 Ferrari A, Stark D, Peccatori FA et al. Adolescents and young adults (AYA) with cancer: a position paper from the AYA Working Group of the European Society for Medical Oncology (ESMO) and the European Society for Paediatric Oncology (SIOPE). ESMO Open 2021; 6: 100096. 9 Osborn M, Johnson R, Thompson K et al. Models of care for adolescent and young adult cancer programs. Pediatr Blood Cancer 2019; 66: e27991. 10 Fardell JE, Patterson P, Wakefield CE et al. A Narrative Review of Models of Care for Adolescents and Young Adults with Cancer: Barriers and Recommendations. J Adolesc Young Adult Oncol 2018; 7: 148-152. 11 Keegan TH, Lichtensztajn DY, Kato I et al. Unmet adolescent and young adult cancer survivors information and service needs: a population-based cancer registry study. J Cancer Surviv 2012; 6: 239-250. 12 Hayashi RJ. Adolescent and young adult cancer survivorship: The new frontier for investigation. Cancer 2019; 125: 1976-1978. 13 Saloustros E, Stark D, Michailidou K et al. Report on ESMO/SIOPE European Landscape project key results: Mapping the status and needs in AYA cancer care. Late-breaking and deferred publication abstracts public health 2017; 28, 5: V643. 14 Smith AW, Seibel NL, Lewis DR et al. Next steps for adolescent and young adult oncology workshop: An update on progress and recommendations for the future. Cancer 2016; 122: 988-999. STRONG-AYA – No. 101057482 – D4.5 9 2. Implementing the COS across several national European healthcare systems. Data will be collected at local level and will then be included in a data integration platform. An overall ecosystem framework for data analytics and output will be created supporting federated analyses and the creation of reports across clinical and patient-reported data and making national repositories of (patient-reported) health data, available to individual patients, patient organisations, regulatory authorities, as well as the patients’ health care providers to inform clinical decision-making. The five resulting national ecosystems will be connected to each other into the pan-European ecosystem using a federated approach also utilizing the overall ecosystem framework. 3. Disseminating the COS to a wide range of local as well as pan-European stakeholders, in particular by developing analytical tools to process and present patient outcome data and establish feedback loops that inform patients and clinicians. Implementing these project objectives are five work packages within the STRONG-AYA project:  WP1: Development Core Outcome Set AYA with cancer and Data Collection (Lead: SOUTHAMPTON)  WP2: Governance, Data Security and Ethics (Lead: EORTC)  WP3: Infrastructure and Interoperability (Lead: UNIMAAS)  WP4: Operation of STRONG-AYA ecosystems, Stakeholder and Patient involvement, Dissemination, Exploitation, Communication (Lead: E.C.O.)  WP5: Scientific Coordination and Project Management (Lead: NKI) STRONG-AYA will enable AYA care and research to benefit from collection and pooling of patient-centered data and collaboration among all stakeholders: patients, healthcare professionals, scientists, and policymakers. More widely, the project will leverage the network of interested organisations and networks established under STRONG-AYA for long-term strengthened promotion of the necessary implementation of specialist AYA cancer services across Europe. This will ultimately bring novel insights into AYA cancer care, research and policy, contributing to the long-term improvement of outcomes for people with AYA cancer. Deliverable introduction The Patient Advisory Board, plays an integral role in the STRONG AYA project by providing patient voices, feedback and co-creation involvement to ensure that the project meets the needs of the very people it intends to serve. The purposes of the attached pamphlet is to provide a comprehensive overview of the project in lay language to support the PAB’s understanding of the project and its outcomes over the course of the project, whilst also serving as a possible resource to provide the public as well.