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NCT05867186 | Recruiting | Pediatric Oncology

Fit to Fight Childhood Cancer
Sponsor:

Johannes Gutenberg University Mainz

Information provided by (Responsible Party):

George Faber

Brief 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.

Condition or disease

Pediatric Oncology

Intervention/treatment

Exercise training

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.}}

Study Type : Observational
Estimated Enrollment : 100 participants
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.
Actual Study Start Date : June 20, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2029

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Fit to Fight Childhood Cancer

Location Details

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Fit to Fight Childhood Cancer

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Locations

Recruiting

Germany, Rhineland-Palatinate

Johannes-Gutenberg-University Medical Center

Mainz, Rhineland-Palatinate, Germany, 55131