Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-06-20
2029-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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 telemedical exercise sessions and/or combine their training with digital tools.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
21 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Joerg Faber
Univ. Prof. Dr. med. Jörg Faber
Principal Investigators
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Joerg Faber, Univ.-Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Johannes-Gutenberg-University Medical Center
Locations
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Johannes-Gutenberg-University Medical Center
Mainz, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Elias Dreismickenbecker
Role: primary
Joerg Faber, MD
Role: backup
Other Identifiers
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22-02372
Identifier Type: -
Identifier Source: org_study_id