Fit to Fight Childhood Cancer

NCT05867186 | Recruiting

• 1 other identifier: 22-02372
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Oncology

Keywords

Paediatric exercise oncology; Precision exercise training; Childhood cancer; Quality of life; Gait; Pain; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cancer-related fatigue score at yearly intervals up to 5 years

  Cancer-related fatigue measured by the Pediatric Quality of Life Inventory (PedsQL) 3.0 Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale is composed of 18 items comprising three dimensions. Scores are transformed on a scale from 0 to 100. Higher scores indicate lower fatigue.

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

Secondary Outcomes (36)

• Change from baseline in the score of resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) at yearly intervals up to 5 years

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

• Change from baseline in the score of resilience (measured by the Brief Resilience Scale (BRS)) at yearly intervals up to 5 years

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

• Change from baseline in the score of resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) at yearly intervals up to 5 years

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

• Change from baseline in general self-efficacy score at yearly intervals up to 5 years

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

• Change from baseline in the score of physical exercise self-efficacy at yearly intervals up to 5 years

  baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years

Interventions

Exercise training BEHAVIORAL

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

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Johannes-Gutenberg-University Medical Center

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joerg Faber, Univ.-Prof. Dr. med.

  Johannes-Gutenberg-University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias Dreismickenbecker

CONTACT

00496131178331; fortee@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr. med. Jörg Faber

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 19, 2023
• Study Start: June 20, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DE (1)