Fit to Fight Childhood Cancer

Trial Title: Fit to Fight Childhood Cancer

NCT ID: NCT05867186

Condition: Pediatric Oncology

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Paediatric exercise oncology
Precision exercise training
Childhood cancer
Quality of life
Gait
Pain
Cardiorespiratory fitness

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Exercise training
Description: 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 telemedical exercise sessions and/or combine their training with digital tools.

Summary: 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.

Criteria for eligibility:

Study pop:
Eligible are children or adolescents from 3 to 21 years of age with a cancer diagnosis according to the International Classification of Childhood Cancer (ICCC). The term "childhood cancer" is most commonly used to designate cancer that arises in children before the age of 18 years. Since patients older than 18 years (especially in the transition phase from adolescence to young adulthood) can also have paediatric tumour entities, the upper age limit for study inclusion was set at 21 years. The Kolibri study includes patients for whom oncological treatment (regardless of the type of therapy) at the Paediatric Oncology Centre of the University Medical Centre Mainz is planned or already being carried out and who are not in the final stage of the disease.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 3 Years

Maximum age: 21 Years

Healthy volunteers: No

Locations:

Facility:
Name: Johannes-Gutenberg-University Medical Center

Address:
City: Mainz
Zip: 55131
Country: Germany

Status: Recruiting

Contact:
Last name: Elias Dreismickenbecker

Phone: 00496131178331
Email: fortee@unimedizin-mainz.de

Investigator:
Last name: Joerg Faber, MD
Email: Principal Investigator

Start date: June 20, 2023

Completion date: July 31, 2029

Lead sponsor:
Agency: Johannes Gutenberg University Mainz
Agency class: Other

Source: Johannes Gutenberg University Mainz

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05867186