Periodic Reporting for period 1 - FORTEe (Get strong to fight childhood cancer: an exercise intervention for children and adolescents undergoing anti-cancer treatment)
Okres sprawozdawczy: 2021-03-01 do 2022-08-31
Cancer is the leading cause of death by non-communicable diseases in children in Europe. During cancer treatment, patients suffer from a wide range of disease related symptoms and side effects of chemo- and/or radiotherapy. One of the most debilitating and distressing side effects is cancer-related fatigue, an extreme feeling of tiredness, lack of energy or exhaustion. Physical inactivity is a further common problem for many cancer patients. Cancer treatment side effects and disease related symptoms can cause a vicious circle of fatigue and physical inactivity, which further negatively impacts physiological functional capacities as well as psychosocial functioning including mental health and health-related quality of life.
Previous studies in adult cancer patients have shown multiple beneficial effects of specific exercise training: An improvement in exercise capacity was associated to a reduced risk of morbidity and mortality in adult cancer patients. A similar effect has not been clearly demonstrated in children and adolescents yet, but personalised exercise training during the intensive phase of childhood cancer treatment seems to be a promising therapy to mitigate above-mentioned issues. However, evidence for using exercise to counteract cancer-related fatigue and improve health-related quality of life is still lacking in paediatric oncology. Until now, precision exercise training has not yet been part of standard care in paediatric oncology and does therefore not reach most patients.
This is where FORTEe steps in to promote exercise therapy, which aims to make young patients stronger for fighting childhood cancer. The overall goal of the FORTEe project is to create high-level evidence for the use of precision exercise interventions in childhood cancer by conducting the world’s largest randomised, controlled trial in this field. We intend to evaluate a personalised and standardised exercise intervention in 450 children, adolescents and young adults undergoing cancer treatment in nine centres across Europe in order to generate evidence for an innovative, patient-centred exercise treatment. Experiences and expertise in paediatric exercise oncology within Europe are merged to develop specific age-adapted and personalised exercise training as well as testing protocols, which are implemented with the help of digital, innovative technologies. During the project lifetime of 5.5 years, FORTEe aims to generate meaningful advances in clinical care for children and adolescents with cancer. This will enable future access to adapted exercise training to children with cancer all over the EU and increase the children’s health-related quality of life.
FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.
Previous studies in adult cancer patients have shown multiple beneficial effects of specific exercise training: An improvement in exercise capacity was associated to a reduced risk of morbidity and mortality in adult cancer patients. A similar effect has not been clearly demonstrated in children and adolescents yet, but personalised exercise training during the intensive phase of childhood cancer treatment seems to be a promising therapy to mitigate above-mentioned issues. However, evidence for using exercise to counteract cancer-related fatigue and improve health-related quality of life is still lacking in paediatric oncology. Until now, precision exercise training has not yet been part of standard care in paediatric oncology and does therefore not reach most patients.
This is where FORTEe steps in to promote exercise therapy, which aims to make young patients stronger for fighting childhood cancer. The overall goal of the FORTEe project is to create high-level evidence for the use of precision exercise interventions in childhood cancer by conducting the world’s largest randomised, controlled trial in this field. We intend to evaluate a personalised and standardised exercise intervention in 450 children, adolescents and young adults undergoing cancer treatment in nine centres across Europe in order to generate evidence for an innovative, patient-centred exercise treatment. Experiences and expertise in paediatric exercise oncology within Europe are merged to develop specific age-adapted and personalised exercise training as well as testing protocols, which are implemented with the help of digital, innovative technologies. During the project lifetime of 5.5 years, FORTEe aims to generate meaningful advances in clinical care for children and adolescents with cancer. This will enable future access to adapted exercise training to children with cancer all over the EU and increase the children’s health-related quality of life.
FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.
We successfully completed all scientific and regulatory requirements for the start of the clinical trial. As one major achievement, the study design was established and a final study protocol was consented. Moreover, we developed detailed protocols for exercise training and testing that are used as teaching materials to support and provide guidance to the exercise professionals who are carrying out the intervention during the clinical trial. The elaborated protocols are standardised to enable adapted personalised exercise training. The intensity, time and volume of exercise are adjusted to the cancer treatment intensity and to each patient´s clinical condition and response. These FORTEe protocols will serve as the basis for guidelines that will be developed and disseminated during the further course of the project.
The patient recruitment within the FORTEe clinical trial started in April 2022 and is ongoing. To be able to analyse the effects of the exercise intervention, a smart data base was set up and is used by the clinical partners.
So far, various digital, innovative technologies were implemented within the FORTEe project: We developed novel applications and tools in exercise oncology and rehabilitation aiming to increase the patient’s motivation to participate in the exercise training and to run remote exercise sessions with childhood cancer patients (e.g. usable for home training sessions or exercise training during isolation). An augmented reality (AR) app was designed to allow patients to perform child- as well as age- and condition-specific exercises with an avatar.
Already at this early stage of the project, we set up mechanisms for the rapid transfer of expert knowledge between sports and exercise science, sports medicine and paediatric oncology expertise across European countries.
The FORTEe project is promoted via the project website, the project brochure, patient flyers and various social media channels
The patient recruitment within the FORTEe clinical trial started in April 2022 and is ongoing. To be able to analyse the effects of the exercise intervention, a smart data base was set up and is used by the clinical partners.
So far, various digital, innovative technologies were implemented within the FORTEe project: We developed novel applications and tools in exercise oncology and rehabilitation aiming to increase the patient’s motivation to participate in the exercise training and to run remote exercise sessions with childhood cancer patients (e.g. usable for home training sessions or exercise training during isolation). An augmented reality (AR) app was designed to allow patients to perform child- as well as age- and condition-specific exercises with an avatar.
Already at this early stage of the project, we set up mechanisms for the rapid transfer of expert knowledge between sports and exercise science, sports medicine and paediatric oncology expertise across European countries.
The FORTEe project is promoted via the project website, the project brochure, patient flyers and various social media channels
Although exercise training has shown benefits in adult as well as childhood cancer patients during and after cancer treatment, no international common standards for the implementation of paediatric exercise oncology have been established so far. Furthermore, only a few hospitals offer exercise programs as an optional add-on to the standard of care. To date, there are no multicentre randomised controlled clinical trials investigating paediatric exercise oncology during intensive cancer therapy. With FORTEe, the scientific basis for optimizing exercise interventions and its establishment as a routine treatment will be provided.
The FORTEe consortium will pool their knowledge and expertise in order to create a vast amount of data to demonstrate that “exercise is medicine” and should be an integral part of clinical practice.
In future, paediatric exercise oncology should be considered as a viable enrichment alongside the already established supportive treatments in cancer.
Moreover, precision exercise therapy is a personalised, but simultaneously highly-standardised treatment concept and thus comparable to drug therapies. Analogous to the correct choice and dosage of a pharmaceutical agent (e.g. antiemetics, analgetics, etc.), the exercise type and training load have to be individually adapted to the patient’s condition and needs. Prescribing exercise like a “pill” in the right “dosage”, might become a highly effective instrument in childhood cancer care for the prevention, treatment and management of the acute side-effects of cancer treatment and its sequelae.
Moreover, FORTEe develops adapted exercise technology supporting the digital transformation of health and care. Using digital tools and applications, FORTEe has started to elaborate common standards that enable exercise training in the patient's home during cancer treatment and during isolation or physical distancing measurements.
Consequently, results will be transferrable to further populations and not only childhood cancer patients could benefit from the results of the FORTEe trial, but also patients suffering from other non-communicable diseases or chronic (paediatric) health conditions such as asthma, diabetes mellitus, obesity, congenital heart disease etc.
FORTEe will provide a basis for the development of clinical practice guidelines in paediatric exercise oncology. The establishment of a comprehensive and standardised exercise therapy for childhood cancer patients all over Europe would be an essential step towards improving and equalizing the standards in patient care and a breakthrough for all children suffering from cancer.
The FORTEe consortium will pool their knowledge and expertise in order to create a vast amount of data to demonstrate that “exercise is medicine” and should be an integral part of clinical practice.
In future, paediatric exercise oncology should be considered as a viable enrichment alongside the already established supportive treatments in cancer.
Moreover, precision exercise therapy is a personalised, but simultaneously highly-standardised treatment concept and thus comparable to drug therapies. Analogous to the correct choice and dosage of a pharmaceutical agent (e.g. antiemetics, analgetics, etc.), the exercise type and training load have to be individually adapted to the patient’s condition and needs. Prescribing exercise like a “pill” in the right “dosage”, might become a highly effective instrument in childhood cancer care for the prevention, treatment and management of the acute side-effects of cancer treatment and its sequelae.
Moreover, FORTEe develops adapted exercise technology supporting the digital transformation of health and care. Using digital tools and applications, FORTEe has started to elaborate common standards that enable exercise training in the patient's home during cancer treatment and during isolation or physical distancing measurements.
Consequently, results will be transferrable to further populations and not only childhood cancer patients could benefit from the results of the FORTEe trial, but also patients suffering from other non-communicable diseases or chronic (paediatric) health conditions such as asthma, diabetes mellitus, obesity, congenital heart disease etc.
FORTEe will provide a basis for the development of clinical practice guidelines in paediatric exercise oncology. The establishment of a comprehensive and standardised exercise therapy for childhood cancer patients all over Europe would be an essential step towards improving and equalizing the standards in patient care and a breakthrough for all children suffering from cancer.