Pediatric Cancer Patients

The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment. A total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group. Children in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment. In addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program. The exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness. The main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects. In addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications. Overall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.

This observational study aims to describe changes in the functional abilities of children, adolescents and young adults with cancer who are undergoing physiotherapy or neuropsychomotor rehabilitation. This is real-world study aiming to describe normal rehabilitation pathways in many different hospitals or rehabilitation centres in Italy. The primary research question is: 1\) What are the longitudinal changes in functional abilities among these patients receiving physiotherapy or neuropsychomotor rehabilitation? The secondary research questions are: 1. What types of rehabilitation practices are implemented across AIEOP centres? 2. What are the rehabilitation needs among patients undergoing physiotherapy or neuropsychomotor rehabilitation? 3. How does health-related quality of life differ across the various stages of the rehabilitation pathway? Participants undergoing usual rehabilitation treatment are evaluated on their functional abilities on a monthly basis. If they agree to participate in this study, the main characteristics of the rehabilitation treatment and the monthly evaluation are collected.

Physical activity and play in early childhood are positively associated with healthy growth and gross motor, social, and cognitive development. Preschool children with cancer are at risk of impairments or delays in these interdependent developmental areas. Therefore, it is imperative to find new rehabilitation approaches to ensure preschool children's development during and after treatment. This study is based on the RePlay trial, where results highlight a demand from families for physical activity during cancer treatment and show that preschoolers want to participate. However, there is a need for a more flexible and accessible physical activity initiative at the hospital and greater support and collaboration with parents, also at home. The purpose of this randomized controlled study is to investigate the effect of 9 months of physical activity at the hospital and at home for 82 preschool children with cancer, aged 1-5 years. The rehabilitation program includes the following components: 1. Facilitated structured active play as group sessions at the hospital 2. A parent education program 3. Online facilitated structured active play in the families' homes The included children will be randomized to either a group only receiving structured active play at the hospital (part 1), or a group receiving both structured active play at the hospital, the parent education program, and online structured active play in the families' homes (parts 1-3). We will measure the children's in gross motor function 9 months after the start of treatment (primary outcome), as well as parents' attitudes towards physical activity and the children's general physical function (secondary outcomes). We will measure at treatment initiation, and 6, 9, and 12 months after treatment initiation. Additionally, we will qualitatively investigate the parents and children's experiences, the potential of the rehabilitation program for the children's social development, and the importance of the professional in facilitating structured active play.