D1.3 - Material for education and clinical implementation

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 – D1.3 2 Deliverable Report WP1: Material for education and clinical implementation Deliverable D1.3 Due date of deliverable: 31/03/24 Actual submission date: 27/03/2024 Project: STRONG-AYA Lead Contributor Nicole Collaço, Anne-Sophie Darlington Email [email protected] [email protected] Other Contributors The Patient Advisory Board STRONG AYA consortium Emails Due date 31.3.24 Delivery date 27.3.24 Deliverable type R Dissemination level PU Description of Work Version Date V1.0 27/03/2024 STRONG AYA – No. 101057482 – D1.3 3 Description: This report includes an overview of the educational leaflets and recommendations for patient recruitment, healthcare professional and strategic leaders/commissioners engagement. Publishable summary The aim of Work Package 1 (WP1) of STRONG AYA is to develop a Core Outcome Set (COS) for adolescents and young adults (AYAs) with cancer. With the initial COS domains and metrics nearing finalisation, WP1 is turning its attention to deliverable 1.3: data collection and implementation. To encourage participation in this next phase of the project, clear and concise educational materials (e.g. leaflets) are essential. We describe the development of educational leaflets to support recruitment to the STRONG AYA project and recommendations for engagement with patients, healthcare professionals (HCPs) and strategic leaders/commissioners. Developed collaboratively with input from patients, HCPs and strategic leaders, these leaflets are designed with an informal tone for patients, a professional tone for healthcare professionals, and a strategic perspective for leaders/commissioners, ensuring appropriate communication with each stakeholder group. Our recommendations for patient recruitment emphasise the importance of concise communication materials, and information sessions aimed at reaching a diverse audience. The use of social media platforms fosters a sense of community, while the active involvement of the Patient Advisory Board personalizes outreach efforts. Incentives, including gift cards and recognition in publications, could be used to thank participants for their invaluable contributions. In engaging healthcare professionals, we recommend ensuring that data collection processes can be well integrated into existing workflows to minimize burden on busy HCPs. Professional development opportunities, and the importance of clinical champions to advocate for the initiative and encourage their colleagues to get involved could enhance engagement. Our recommendations for securing support from strategic leaders and commissioners emphasise the project's alignment with organisational goals and financial viability. Regular updates and facilitated stakeholder meetings are key components in gaining buy-in and sustained commitment from these key stakeholders. Together, these initiatives can encourage active participation and support, and ultimately contribute to meeting STRONG AYA’s aim to improve patient-centred health research and outcomes for young people with cancer. STRONG AYA – No. 101057482 – D1.3 4 1 Table of Contents PUBLISHABLE SUMMARY ............................................................................................................................................ 3 1 TABLE OF CONTENTS .......................................................................................................................................... 4 2 DEFINITIONS....................................................................................................................................................... 5 3 ABBREVIATIONS ................................................................................................................................................. 6 4 INTRODUCTION .................................................................................................................................................. 7 PROJECT BACKGROUND ........................................................................................................................................... 7 DELIVERABLE INTRODUCTION .................................................................................................................................... 8 5 EDUCATIONAL LEAFLETS .................................................................................................................................... 9 6 RECOMMENDATIONS FOR PATIENT RECRUITMENT, HCP AND STRATEGIC LEADERS/ COMMISSIONERS’ ENGAGEMENT ...........................................................................................................................................................10 7 CONCLUSION .....................................................................................................................................................12 8 APPENDICES ......................................................................................................................................................13 STRONG AYA – No. 101057482 – D1.3 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 – D1.3 6 3 Abbreviations Acronym/Abbreviation Meaning HCP Healthcare Professional 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) KPI Key Performance Indicator OA Open Access PAB Patient Advisory Board EC European Commission HADEA European Health and Digital Executive Agency SC Steering Committee MT Management Team STRONG AYA – No. 101057482 – D1.3 7 4 Introduction Project background STRONG AYA is an EU-funded project that started in October 2022 and will run for 5 years, until 2027. The project aims to create a new, interdisciplinary, multi-stakeholder European network around an innovative data ecosystem to improve health care services, research, outcomes and policies for AYAs with cancer, which are defined for the project as individuals aged 15-39 years at cancer diagnosis. Cancer at adolescent and young adult (AYA) age is rare; 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, 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 age-appropriate and high-quality healthcare. 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. 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 AYAs14. There is a lack of data standardisation, 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 STRONG AYA – No. 101057482 – D1.3 8 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 (WP1). • 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. 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 WP1 (developing a Core Outcome Set): The overall aim of WP1 is to develop a Core Outcome Set for AYAs with cancer. We aim to assess which outcomes including patient-reported outcomes, clinical, and treatment data, are most important to assess for AYAs with cancer, from the point of view of AYAs with cancer, healthcare professionals and other stakeholders, to arrive at a consensus. This will be done through three phases; 1) a review of the literature to identify relevant outcomes for AYAs with cancer, 2) qualitative interviews with AYAs with cancer/who have had a diagnosis of cancer, parents/partners/siblings and healthcare professionals who provide care to AYAs to generate a complete list of outcomes of relevance to AYAs with cancer, and 3) conducting a Delphi study. The Delphi technique is used for achieving convergence of opinion from all stakeholders (with equal contributions) on the importance of different outcomes in multiple anonymised prioritisation rounds. A three-round survey will be sent to stakeholders asking questions around outcomes relevant to AYAs cancer care ranking them based on perceived level of importance. STRONG AYA – No. 101057482 – D1.3 9 With the initial COS domains and metrics nearing finalisation, WP1 is turning its attention to D1.3: data collection and implementation. To encourage participation in this next phase of the project, clear and concise educational materials (e.g. leaflets) are essential. This report outlines the purpose of the educational leaflets, why they were developed and how they were produced. We also report on recommendations for patient recruitment and engagement of clinicians and strategic leaders/commissioners. 5 Educational leaflets In this report, we describe the development and purpose of three sets of educational leaflets designed to improve recruitment to the data collection and implementation phase of the STRONG AYA project. Designed with an informal tone, these leaflets underwent a collaborative design process involving patients from the Patient Advisory Board (PAB), researchers and healthcare providers (HCPs) within the STRONG AYA consortium. Initially created using Canva and enhanced with the help of a graphic designer, these leaflets are designed to complement existing Patient Information Form (PIF) documents to be provided by individual participating centres. The leaflets explain STRONG AYA, what data will be collected, how the data will be used, and the benefits to participants who take part. Development Process The three sets of educational leaflets, tailored for patients, healthcare professionals and strategic leaders/commissioners, were initially created on Canva (https://www.canva.com/). The leaflet is split into eight short sections of text; What is STRONG AYA, What are we doing?, What information are we collecting?, Why are we collecting your information?, How will we use your information?, How you can get involved?, Data Privacy and ethics and How will this benefit me? The writing style maintains a patient-friendly tone for patient leaflets, a professional tone for HCPs and a strategic perspective for leaders/commissioners, ensuring it's relevance for all intended audiences. A collaborative approach was taken to the development of these leaflets, seeking insights from patients, HCPs and strategic leaders/commissioners within the STRONG AYA consortium. Feedback from this extensive review process has been incorporated into subsequent revisions. Content of leaflets Patient leaflet (see appendix 1) The patient leaflets explain the importance of contributing their data for this project. The review process, involving the Patient Advisory Board, ensures that the content of the leaflet resonates with the intended audience. In addition, a dedicated section in the patient leaflet only encourages patients not only to participate in data collection, but also to actively co-design the digital platform. The digital platform serves as a tool of data collection of patient reported outcomes. Therefore, patients' involvement in shaping its features ensures that it meets their unique needs and preferences. HCP (see appendix 2) Leaflets for healthcare providers focus on encouraging engagement of young people taking part in this research initiative. What is STRONG AYA? STRONG AYA is an international project that aims to improve healthcare services, research and outcomes for adolescents and young Adults (AYA) with cancer, defined as individuals aged 15-39 years at cancer diagnosis. What do we do? We've been talking to young people with cancer, their families, doctors, and researchers worldwide to find out what's most important in understanding and treating cancer for this age group. They told us about things like wanting to socialize, managing fertility concerns, dealing with 'chemo brain,' and feeling heard by their doctors. We've put all this info into a simple list we call a Core Outcome Set (COS). We’re using the COS to help us with the next steps. We're collecting information from young people across healthcare systems in five European countries. Check out the 'what information are we collecting' and ‘how you can get involved’ sections to understand what information we’re collecting and how you can help. Our goal is to share what we've learned, encourage collaboration between different groups, and use smart tools to make sure healthcare professionals and researchers have the best information for deciding on age-appropriate care. By understanding the specific needs of young people with cancer, we want to make sure the care provided really meets what they truly need. What information are we collecting? We are gathering information from AYAs, about their experience with cancer after diagnosis (e.g. symptoms), overall health and wellbeing. Why are we collecting this information? To improve cancer care services and quality of life after diagnosis and treatment for AYAs. Healthcare professionals We’re gathering information from AYAs through a secure digital platform. This platform will help AYAs and healthcare professionals like yourself share information and insights into the AYA’s health (e.g. symptoms) and overall wellbeing from diagnosis and beyond. Patient’s individual information is combined with those of other patient’s to create collective information so that no one is identifiable. This collective information helps us understand trends, discuss improvements and provide evidence for clinical, research, and policy purposes. Healthcare professionals play a vital role in our work. You can encourage patients to complete the survey evaluating outcomes. This can be done as many times as needed, but at least once a year. The survey covers different aspects such as symptoms, quality of life, sleep, diet, and daily activities, to improve healthcare understanding and support. Patient data can be collected in a variety of ways: by email, by telephone or at an appointment. STRONG AYA is spread across five different healthcare systems so practice may vary between hospitals. For more details, please see the patient information provided. STRONG AYA aims to equips healthcare professionals by providing essential data for optimizing AYA cancer care. This intends to support shared decision-making, monitor healthcare quality, enhance research data sharing, and delivers real-world evidence. By sharing insights with policymakers, we collectively work to address and reduce inequalities in AYA cancer care across Europe. We take privacy seriously. In STRONG-AYA, we strictly adhere to data protection, privacy and patient rights, following regulations such as EU GDPR and national guidelines. The use of this platform has been checked and approved by the relevant health service and academic research ethics committees in the participating centres. How will we use this information? How you can get involved? Data privacy and ethics How will this benefit me? https://strongaya.eu strong_aya [email protected] strong_aya_eu STRONG AYA is funded by the European Union (Grant Agreement No. 101057482). The views expressed are solely those of the author(s) and do not necessarily reflect the opinions of the European Union or the Health and Digital Executive Agency (HADEA). The European Union and the granting authority cannot be held responsible for these views. This project is further supported by Innovate UK under grants 10038931, 10039273, 10041045, and 10044189. What is STRONG AYA? STRONG AYA is an international project that aims to improve healthcare services, research and outcomes for adolescents and young Adults (AYAs) with cancer, defined as individuals aged 15-39 years at cancer diagnosis. What do we do? What information are we collecting? Why are we collecting this information? To improve cancer care services and quality of life after diagnosis and treatment. Commissioners and policymakers We are collecting information from AYAs (aged 15-39 years), about their cancer experiences after diagnosis (e.g. symptoms), their health, and overall wellbeing. We've been talking to young people with cancer, their families, doctors, and researchers worldwide to find out what's most important in understanding and treating cancer for this age group. They told us about things like wanting to socialise, managing fertility concerns, dealing with 'chemo brain,' and feeling heard by their doctors. We've put all this info into a simple list we call a Core Outcome Set (COS). We’re using the COS to help us with the next steps. We're collecting information from young people across healthcare systems in five European countries. Check out the 'what information are we collecting' and ‘how you can get involved’ sections to understand what information we’re collecting and how you can help. Our goal is to share what we've learned, encourage collaboration between different groups, and use smart tools to make sure healthcare professionals and researchers have the best information for deciding on ageappropriate care. By understanding the specific needs of young people with cancer, we want to make sure the care provided really meets what they truly need. We’re collecting information from patients through a secure digital platform. This platform will help AYAs and healthcare professionals have the option to share information and get a better understanding into the AYA’s health (e.g. symptoms) and overall wellbeing from diagnosis and beyond, should they wish. Patient’s individual information is combined with those of other patient’s to create collective information so that no one is identifiable. This collective information helps us understand health trends, discuss improvements and provide evidence for clinical, research, and policy purposes. Encourage healthcare providers to facilitate patient participation in our annual survey, accessible online, on paper, or with assistance from our team in person, over the phone, or via secure video-chat. This survey focuses on various aspects of health and wellbeing. STRONG AYA aims to provide crucial insights into patient experiences and needs. This data aids in informed decision making for resource allocation, service improvement, and strategic planning. The survey data will contribute to more effective and tailored healthcare services. This strategic approach ensures a more sustainable healthcare system that aligns with both patient needs and economic considerations. We take privacy seriously. In STRONG-AYA, we strictly adhere to data protection, privacy and patient rights, following regulations such as EU GDPR and national guidelines. The use of this platform has been checked and approved by the relevant health service and academic research ethics committees in the participating centres. How will we use this information? How you can get involved? Data privacy and ethics How will this benefit me? https://strongaya.eu strong_aya [email protected] strong_aya_eu STRONG AYA is funded by the European Union (Grant Agreement No. 101057482). The views expressed are solely those of the author(s) and do not necessarily reflect the opinions of the European Union or the Health and Digital Executive Agency (HADEA). The European Union and the granting authority cannot be held responsible for these views. This project is further supported by Innovate UK under grants 10038931, 10039273, 10041045, and 10044189.