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Adverse events during supervised sports therapy interventions
An Adverse Event (AE), or in German 'unerwünschtes Ereignis' (undesired event), is an undesirable incident that occurs in a special situation such as cancer during a sports session for children and young people.
In recent decades, the survival rates of children and adolescents with cancer have improved, with an increased focus on improving quality of life and reducing side effects. Supervised sports therapy interventions are considered a promising approach to promoting health-related quality of life and reducing therapy-related burdens. Initial studies show positive effects on physical performance, fatigue, and quality of life, but the evidence base is still limited and information on adverse events (AEs) is largely lacking. In Germany, many pediatric oncology centers already have supplementary exercise programs, and the ActiveOncoKids network is working on the nationwide expansion of such programs as well as the qualification of specialist personnel. The long-term goal is to have detailed knowledge of the risk-benefit potential and to develop and deepen prevention recommendations.
Phase 1
In 2020, a retrospective survey was conducted in which data from various sports therapy programs at 24 pediatric oncology centers in Germany were collected, which had offered sports therapy interventions in the previous year. A total of 35,110 documented units were analyzed. The evaluation revealed an AE incidence of 17 per 100,000 interventions, with serious adverse events (Grade 2-3) being extremely rare with only six cases. Mild AEs (Grade 1), such as muscle soreness, circulatory problems, or stomach aches, occurred less frequently than in healthy children and adolescents.
Phase 2
The prospective, multicenter observational study for the recording and classification of AEs during supervised sports therapy interventions, with the objective of developing recommendations for the prevention of AEs, was conducted from January 2022 to December 2024. Evaluated by a multi-professional working group, the data is currently being evaluated and subsequently published.
Multicenter Working Group
Reports
Phase 3
From May 2025, following a positive ethics vote, supplementary detailed information on adverse events of CTCAE Grade 2 and above will be systematically collected in a total of 17 pediatric oncology centers.
This includes basic data such as gender, date of birth, state, and information about previous sports experience. In addition, medical parameters will be recorded, including the main diagnosis, the date of the initial diagnosis, the therapy protocol used, possible secondary diagnoses, exercise-related medical complications, as well as information on medication. Furthermore, psychosomatic abnormalities are to be documented and the contact details of the legal guardians (phone number and email address) will be stored for possible queries.
Spontaneous Reporting System
NAOK offers a Spontaneous Reporting System that you, as a family or exercise professional, can use anonymously to report undesirable events that occur during sports in the clinic or in aftercare. Please fill out the form, and if you give your consent, we will contact you to clarify any questions.
