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Filter by:This study protocol describes the design and methods of the PanCareSurPass (PCSP) multi-country implementation study of the Survivorship Passport v2.0 (short: PCSP implementation study), which is part of the PCSP project that has received funding through the European Union (EU) Horizon 2020 Programme. The cohort study will inform researchers and stakeholders on the process and outcomes of implementing the Survivorship Passport (SurPass) v2.0 in the Electronic Health Information Systems (EHIS) of six clinics in the EU countries Austria (CCRI), Belgium (KU Leuven), Germany (UMC-Mainz/UzL), Italy (IGG), Lithuania (VULSK) and Spain (HULAFE). The SurPass comprises two main components, the Treatment Summary (TS) including demographic, diagnosis and treatment data and the personalized Survivorship Care Plan (SCP) including individual follow-up care recommendations. The SCP is based on internationally approved, organ-specific follow-up care recommendations. The SurPass is used as a tool to assist both Childhood Cancer Survivors (CCS) and Health Care Providers (HCPs) to improve Long-Term Follow-Up (LTFU) care, in a care partnership, supporting CCS empowerment and satisfaction with care, as well as shared decision-making by CCS and HCPs. People-centred care is important in CCS since they are a vulnerable population known to be at higher risk of developing chronic conditions as compared to their peers in the general population. The overall aim of the cohort study is to evaluate the implementation of the SurPass v2.0 in the six centres by testing the feasibility of test wise implementation of the SurPass v2.0 in different health system scenarios and assessing the people-centred LTFU care for CCS with the SurPass as a tool and the cost effectiveness. Six long term follow-up clinics across Europe will enrol eligible, consented CCS and generate personalised digital SurPass. Eligible participants for the main study cohort will be CCS more than 5 years after diagnosis and with an identified treatment burden based on actual exposure to respective treatments (Cumulative Treatment Doses (CTD) of chemotherapy, immunotherapy, radiotherapy). In preparation of the clinic visit, HCPs/local data monitors will use the SurPass v2.0 platform to generate the TS (semi-automated or manual data entry) from which, in turn, the preliminary SCP is automatically created using the built-in algorithms for each consented survivor. During the clinic visit the preliminary SCP is discussed with the Survivor, and tailored to meet the CCS personal needs and a final SCP will be generated. The SCP will include detailed country-specific recommendations, where applicable. The SurPass v2.0 (TS + SCP) will then be integrated into the institutional EHIS, as well as in the survivor's national/regional Electronic Health Platform (EHP) where available. CCS who give informed consent will complete (online) study questionnaires at two measuring points: before the visit to the clinic, and after they received the SurPass during the clinical visit. HCPs will also provide study data: the TS which went into the SurPass (clinical data) and data to monitor the implementation and assess the barriers and facilitators of implementing the SurPass. In addition, data will be collected from both survivors and health care providers to assess the cost-effectiveness of implementing the SurPass. Regarding the outcome evaluation, the main outcome is the change in levels of activation of survivor or caregiver, as assessed using the Patient Activation Measure (PAM) prior and after clinic visit. Further measurements will be made related to: empowerment, satisfaction with the digital SurPass tool, emotional impacts, quality of life and additional costs of CCS. The main outcome will be analysed by multivariable logistic regression. Analysis for the secondary outcomes will be mostly descriptive. The economic assessment will be analysed by cost analysis, cost utility analysis and multi-criteria decision analysis. The study will be conducted in accordance with the guidelines of good clinical practice (ICH/GCP) and the Helsinki Declaration. The investigators will carefully address all ethical, legal and safety aspects of the study and fully comply with prevailing national and EU regulations and legislation.
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population. In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group. Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood. The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition. If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.