Work Packages

• WP1 – Project Management (UMC-Mainz, concentris)

  The coordinator and concentris together form the project management office. The project management office at concentris is the first point of reference for researchers involved in FORTEe. The coordinator (UMC-Mainz) will be responsible for the tasks defined in the grant agreement and represents the consortium vis-à-vis the European Commission (EC).

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  Management tasks include:

  • Monitoring that the action is implemented properly
  • Acting as the intermediary for all communications between the beneficiaries and the EC
  • Requesting and reviewing any documents or information required by the EC and verify their completeness and correctness
  • Submitting the deliverables and reports to the EC in accordance with the timing and conditions set out in the grant agreement
  • Receiving payments from the EC and distributing the payments to the beneficiaries without unjustified delay
  • Informing the EC of the amounts paid to each beneficiary when requested by the EC
  • Providing any information relevant to checks, reviews, and audits or the evaluation of impact
  • Submitting any required ethical documents to the EC
• WP2 – Ethics and Legal Issues (UMC-Mainz)

  This WP will be led by UMC-Mainz together with all FORTEe recruiting centres. Children and adolescents with cancer represent a particularly vulnerable group whose interests, however, are usually defined through the eyes of adults.

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  Based on a pilot study funded within the DFG Research Training Group „Life Sciences – Life Writing“ (GRK 2015/2) at UMC-Mainz, WP2 will generate empirical data by the means of qualitative social research in order to better determine the children’s best interest regarding quality of life, bodily self-image and burden of disease as well as burden of study-specific intervention. Especially the long-standing experience in regulatory affairs enables the coordinator of WP2 to support the FORTEe-consortium as a one-stop agency for an ethically responsible, socially valuable, legally justifiable and clinically relevant research strategy. In this regard the WP2 will in particular:

  • Support the ethically and legally responsible implementation of research particularly by ongoing risk-benefit analysis of recruitment
  • Monitor the study with a focus on recruitment, communication with and participation of minors and their parents
  • Monitor case reports with regard to the children’s well-being and the quality of interaction with study participants and their proxies
  • Provide qualitative data on subjective self-assessment from random sample survey to better understand risks and benefits of intervention/exercise
  • Provide ethical expertise for external communication and publication activities together with WP6

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• WP3 – Clinical Trial (MBBM)

  The main objective of WP3 is to ensure the successful onset, execution and completion of the randomised clinical trial (RCT), aimed at the evaluation of the impact of a precision exercise program in children and adolescents with cancer. The leading expertise all over the European countries will pool their knowledge in order to generate a vast amount of data to demonstrate that “exercise is medicine”.

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  Our ambition is to demonstrate that precision exercise training can improve the patients’ physical performance, reduce their fatigue and improve their resilience and quality of life. This WP is strictly interfaced with WP2 (ethics) and WP5 (data management and analysis). By data emerging from the clinical trial, it will be possible to fulfil the goals presented in WP6 (dissemination). A new approach within FORTEe is the development of new technology tools (WP4) to improve the exercise programs executed during the clinical trial. Thus, the following objectives will be pursued by WP3:

  • Develop protocols for the exercise testing and intervention phases, to be used by all the recruitment centres during the experimental phase
  • Setup and design an innovative exercise App (FORTEe App), supporting the exercise professionals to monitor the patients’ exercise trainings
  • Support each recruiting centre to set up the randomised controlled trial protocol, standard operating procedures (SOP) and develop the patient recruitment, and data collection
  • Provide a full organisational support to the consortium in inserting the ongoing trial in the smoothest way into the daily clinical routine.
• WP4 – Development of novel Technology Applications in Rehabilitation (OBU)

  The importance of exercise for children and adolescents with cancer is not only obvious from a rehabilitation point of view, but also from a longer-term maturation and secondary prevention point of view. The main challenge in this context is the exercise provision when either resources are not available in the hospital in ever more stretched health services or when the patient is at home.

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  One solution to this is technology in the form of mobile augmented reality devices that could be used to bridge the gap between hospital and community-based rehabilitation. Complimenting this community-based technology intervention, screen-based technology has come to the fore as an effective way of providing functional training with exercise instructions and direct feedback in real-time using camera systems. This technology already exists in the form of the Pixformance device with an in-unit camera that scans 26 body points for precise motion capture. However, there is currently no children-specific application. Pixformance will help to support health and exercise professionals delivering exercise to larger groups of patients and/or give patients independent access to exercise (e.g. within rural areas or during physical distancing respectively during recovery periods at patients’ homes). Moreover, Pixformance aims to improve the exercise provision for this population significantly while hospitalised – especially when human resources are scarce. The aims of WP4 are therefore the development of an augmented reality software with age and condition-specific exercises as well as a children-specific exercise application for the Pixformance device in order to offer additional exercise provision options during the hospitalised phase and at home.

  • Develop an age and condition-specific augmented reality software including an avatar.
  • Provide other centres of the FORTEe project with the augmented reality devices and technology. Managing the exercise training and data collection of this part of the project.
  • Develop an age and condition-specific software for the Pixformance device in collaboration with the company.
  • Manage the training and data collection of this part of the project
• WP5 – Smart Data Management and Analytics (UKHD)

  WP5 will build an appropriate data infrastructure within FORTEe by creating a smart electronic database. Further, WP5 will develop a mechanism to export pseudonymised data for further analysis with external tools. This will be realised in close cooperation with UMC-Mainz in WP2 to ensure personal and health data protection.

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  Moreover, WP5 will develop a statistical analysis plan and standard operating procedures for each clinical site. In close collaboration with WP3, the WP5 will carry out data exploration, visualisation and statistics in a way that uncovers new insights into the research questions being asked. The data management in WP5 will be conducted at UKHD with the support of the Coordination Centre for Clinical Trials (KKS) Heidelberg, which is certified as highly qualified data centre by the European Clinical Research Infrastructure Network (ECRIN). The statistical analysis in WP5 will be performed by a well experienced statistician of the Interdisciplinary Centre for clinical Studies (IZKS) at UMC-Mainz. NURO as expert in media and software development will work together with UKHD in WP5 to assure a proper and easy-to-use data transfer of the FORTEe app to the database. NURO bundles high design and software competence as well as know-how related to the market and communication.

• WP6 – Dissemination, Exploitation, Knowledge Management (concentris)

  Concentris is specialised in the management of EU-funded research projects and highly experienced in supporting dissemination and outreach activities. Their science communication team has experience in medical writing, public relations and organisation of press conferences, social media and web-design.

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  The Universitätsmedizin der Johannes Gutenberg-Universität Mainz (UMC-Mainz) is a centre for medical innovation, committed to the advancement of health care and aims to play a nationally and internationally recognised leading role in improving the quality of health care including E-health. As such, the UMC-Mainz is experienced in education and dissemination of knowledge among the different stakeholders. The Foundation Youth Cancer Europe (YCE) is a patient organisation that incorporates youth cancer networks across Europe and is –as a stakeholder- already actively involved in the outreach of the European Commission on Europe’s Beating Cancer Plan. Thus, YCE is essential for the promotion of FORTEe results in collaboration with the health professionals among young people with childhood cancer across Europe and to help promote awareness of childhood cancer-related complications and positive effects of exercise training. The information provided by the YCE will reach members in 31 countries in European Union including Israel. The coordinator of the nationwide ActiveOncoKids network in Germany (UKESSEN) as a FORTEe partner and the European College of Sport Science (ECSS) as member of the FORTEe Scientific and Ethical Advisory Board (SEAB) will support FORTEe with dissemination to their established communication channels (e.g. the network ActiveOncoKids, NAOK, as part of Society for Paediatric Oncology and Haematology, GOPH). With more than 250 direct contacts and several thousand indirect contacts (with around 20 locations in the network, each with paediatric oncology clinics) per year within the childhood cancer community, UKESSEN will greatly facilitate uptake of new knowledge by the scientific community, the general public and patients in Europe.

• WP7 – Ethics requirements (UMC-Mainz)

  The objective of WP7 is to set out and ensure compliance with the ethics requirements of the individual partner institutions and of the European Union.

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  Important topics addressed by WP7 include:

  • Regulatory and ethical compliance (e.g. regulatory and ethical approvals for the FORTEe trial, including requirements for research involving biomaterials)
  • Data protection and privacy (e.g. data protection compliant processing of personal data of FORTEe trial participants)
  • Regular external review of the FORTEe trial by the Scientific Ethics Advisory Board (SEAB) (e.g. management and evaluation of the annual SEAB reports)