INTRODUCTION: Long-term survival after childhood cancer often comes at the expense of late, adverse health conditions. However, survivorship care is frequently not available for adult survivors in Europe. The PanCareFollowUp Consortium therefore developed the PanCareFollowUp Care Intervention, an innovative person-centred survivorship care model based on experiences in the Netherlands. This paper describes the protocol of the prospective cohort study (Care Study) to evaluate the feasibility and the health economic, clinical and patient-reported outcomes of implementing PanCareFollowUp Care as usual care in four European countries. METHODS AND ANALYSIS: In this prospective, longitudinal cohort study with at least 6 months of follow-up, 800 childhood cancer survivors will receive the PanCareFollowUp Care Intervention across four study sites in Belgium, Czech Republic, Italy and Sweden, representing different healthcare systems. The PanCareFollowUp Care Intervention will be evaluated according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Clinical and research data are collected through questionnaires, a clinic visit for multiple medical assessments and a follow-up call. The primary outcome is empowerment, assessed with the Health Education Impact Questionnaire. A central data centre will perform quality checks, data cleaning and data validation, and provide support in data analysis. Multilevel models will be used for repeated outcome measures, with subgroup analysis, for example, by study site, attained age, sex or diagnosis. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the guidelines of Good Clinical Practice and the Declaration of Helsinki. The study protocol has been reviewed and approved by all relevant ethics committees. The evidence and insights gained by this study will be summarised in a Replication Manual, also including the tools required to implement the PanCareFollowUp Care Intervention in other countries. This Replication Manual will become freely available through PanCare and will be disseminated through policy and press releases. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NL8918; https://www.trialregister.nl/trial/8918).

Childhood Cancer International Europe Vienna Austria

Childhood Cancer Research Group Danish Cancer Society Research Center Copenhagen Denmark

Department of Clinical Medicine and Faculty of Health Aarhus Universitet Aarhus Denmark

Department of Clinical Sciences Lund Oncology Lund University Skane University Hospital Lund Sweden

Department of Clinical Sciences Lund Paediatrics Lund University Skane University Hospital Lund Sweden

Department of Health and Social Care Management University of Eastern Finland Kuopio Campus Kuopio Finland

Department of Health Sciences and Medicine University of Lucerne Lucerne Switzerland

Department of Hematology Radboudumc Nijmegen The Netherlands

Department of Paediatric Haematology and Oncology KU Leuven University Hospitals Leuven Leuven Belgium

Department of Paediatrics Emma Children's Hospital Amsterdam UMC University of Amsterdam Amsterdam The Netherlands

DOPO Clinic Department of Hematology Oncology IRCCS Istituto Giannina Gaslini Genoa Italy

European Society for Pediatric Oncology Brussels Belgium

International Clinical Research Centre at St Anne's University Hospital Masaryk University Faculty of Medicine Brno Czech Republic

Netherlands Institute for Health Services Research Utrecht The Netherlands

PanCare Bussum The Netherlands

Pintail Limited Dublin Ireland

Princess Maxima Center for Pediatric Oncology Utrecht The Netherlands

Royal Victoria Infirmary Great North Children's Hospital Newcastle upon Tyne UK

Scientific Institute for Quality of Healthcare Radboudumc Nijmegen The Netherlands

Wolfson Childhood Cancer Research Centre Newcastle University Centre for Cancer Newcastle upon Tyne UK

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