Fit to Fight Childhood Cancer
ConditionPediatric Oncology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-21
SponsorJohannes Gutenberg University Mainz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Exercise training
BehavioralExercise 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 yearsSecondary outcomes
1
Change from baseline in the score of resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) at yearly intervals up to 5 years
Stress reactivity measured by the Mainz Resilience Score for childhood cancer (MRScc). The MRScc consists of 4 dimensions on mental health problems and 6 dimensions on stressor exposure. For both categories mental health problems and stressor exposure 4 - 400 points can be achieved. To calculate the resilience score, the category mental health problems is divided by the category stressor exposure. A score \>0 means low resilience, a score \< 0 means high resilience.
Time frame
baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years2
Change from baseline in the score of resilience (measured by the Brief Resilience Scale (BRS)) at yearly intervals up to 5 years
Resilience will be evaluated using the Brief Resilience Scale (BRS). BRS is a 6 item scale, the items are rated from 1 to 5. A total score is calculated by determining the sum of the individual items which result in a total score ranging from 6 to 30. A higher score means a higher resilience.
Time frame
baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years3
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
Resilience will be evaluated using the Child \& Youth Resilience Measure-Revised (CYRM-R). The items within the measures can be directly summed to gain a total score of an individual's resilience. For the unmodified 5-point measure (with responses going from 1-5), the minimum score is 17 and the maximum score is 85. For the overall measure and subscales, higher scores indicate characteristics associated with resilience.
Time frame
baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 years4
Change from baseline in general self-efficacy score at yearly intervals up to 5 years
General self-efficacy will be evaluated using the General self-efficacy scale (GSE). The total score is calculated by finding the sum of the 10 items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time frame
baseline, after 1 year, after 2 years, after 3 years, after 4 years, after 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov