Clinical trial NCT05867186: Fit to Fight Childhood Cancer
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Oncology
Keywords: Paediatric exercise oncology
Precision exercise training
Childhood cancer
Quality of life
Gait
Pain
Cardiorespiratory fitness
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in cancer-related fatigue score at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
Secondary outcomes:
measure: Change from baseline in the score of resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score of resilience (measured by the Brief Resilience Scale (BRS)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: 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
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in general self-efficacy score at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score of physical exercise self-efficacy at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the risk status of pain-related outcomes at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the subjective pain perception (measured with the face pain scale - revised (FPS-R)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the subjective pain perception (measured via visual analog scale (VAS)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the fear of pain (parents) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score of pain vigilance and awareness at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the physical activity level (measured by the Modified Children's Physical Activity Questionnaire (mCPAQ)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the physical activity level and behaviour (measured by half-structured interview) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the physical activity level and behaviour at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in peak oxygen uptake (VO2peak) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change in functional capacity at yearly intervals from baseline up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change in submaximal endurance performance (measured by the assisted 6-minute cycling test) at yearly intervals from baseline up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in motor function at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in lower limbs flexibility at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in hamstrings flexibility at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in functional strength at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in arm/ leg strength at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in static balance (measured by the Static Stand Test) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in functional/dynamic balance (measured by the Berg Balance Scale) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in phase angle by means of bioelectrical impedance analysis for the examination of body composition at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score of mental health (measured by WHO (Five) Well-Being Index) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score of mental health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score general health-related quality of life at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in the score cancer-related health-related quality of life at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in gait pattern at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in functional mobility (measured by the Gillette Functional Assessment Questionnaire - Walking Scale) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in functional mobility (measured by the Functional Gait Index) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Change from baseline in functional mobility (measured by the Timed-up-and-go test) at yearly intervals up to 5 years
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Information on comorbidities (including COVID-19 and its potential long-term effects)
timeFrame: baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years
measure: Composite multidimensional socioeconomic status index
timeFrame: baseline
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes-Gutenberg-University Medical Center
state: Rhineland-Palatinate
Study officials:
affiliation: Johannes-Gutenberg-University Medical Center
name: Joerg Faber, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: