Fit to Fight Childhood Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise training.
- Who it may be relevant to
- Registry conditions: Pediatric Oncology. Basic parameters: 3 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fit to Fight Childhood Cancer: An Explorative Long-term Study on Exercise and Its Influence on Physical Performance and Psychosocial Aspects in Childhood Cancer Patients During and After Cancer Treatment.
Overview
The aim of the study is to investigate the influence of exercise on physical performance and psychosocial aspects in children and adolescents with cancer during and after treatment.
Detailed description
The longitudinal, prospective and monocentric cohort study at the University Medical Centre Mainz is based on the Europe-wide, multicentre FORTEe study \[NCT05289739\]. The Kolibri study aims to complement the FORTEe trial. Kolibri allows the inclusion of patients who are not receiving chemotherapy and/or radiotherapy or who are undergoing oncological aftercare.
The longitudinal design of the study will allow the effects of exercise therapy on cancer-related fatigue, health-related quality of life and other psychosocial outcomes, as well as on physical function, to be monitored over the course of oncological treatment, and will provide conclusions about the effectiveness and benefits of exercise therapy. This will enable the establishment and improvement of exercise therapy protocols, as the effects of the exercise dose applied can be observed and compared over time.
The project will also validate and test the reliability of the Mainz Resilience Score in childhood cancer (MRScc) developed in the FORTEe project. The aim is to establish a validated questionnaire to assess resilience in children and adolescents with cancer, as no questionnaires are currently available.
Interventions
- Behavioral Exercise training
Exercise training during intensive cancer treatment, maintenance therapy and aftercare. Training mainly consists of age-appropriate and personalised endurance, strength, flexibility, balance/coordination and gait training. Exercise is provided 3 to 5 times a week lasting for 45 to 60 minutes under supervision during inpatient and outpatient stays, as well as at home. At home, patients train independently according to the exercise recommendations of the exercise professionals, receive supervised
Primary outcome measures
- Change from baseline in cancer-related fatigue score at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
Secondary outcome measures (12)
- Change from baseline in the score of resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the score of resilience (measured by the Brief Resilience Scale (BRS)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the score of resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in general self-efficacy score at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the score of physical exercise self-efficacy at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the risk status of pain-related outcomes at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the subjective pain perception (measured with the face pain scale - revised (FPS-R)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the subjective pain perception (measured via visual analog scale (VAS)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the fear of pain (parents) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the score of pain vigilance and awareness at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
- Change from baseline in the physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) at yearly intervals up to 5 years [Time frame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years]
Eligibility criteria
Inclusion criteria
- Oncological disease according to the International Classification of Childhood Cancer.
- Planned or started anti-cancer treatment (chemo- and/or radiotherapy and/or surgery) at the Clinic and Polyclinic for Paediatrics and Adolescent Medicine of the University Medical Centre of the Johannes Gutenberg University Mainz or connection to the Paediatric Oncology Centre Mainz within the framework of aftercare.
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
- Existing informed consent (or assent) to participate in the study.
- The patient is not in a terminal phase of the disease.
Exclusion criteria
- The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
- After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial. In the case of minor patients (<16 years of age): The legal guardians do not assume that the child/adolescent is able to freely decide on participation or to consent to participation on the basis of the information received, and do not consent to this themselves.
- The patient (and the legal guardians) has/have insufficient knowledge of the German or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
- The patient is in a terminal phase of the disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Johannes-Gutenberg-University Medical Center — Mainz
Identifiers
NCT: NCT05867186 · 22-02372