C00-C97
Conditions
Interventions
Group 1: Experimental: Exercise group
Usual medical care + supervised exercise training during intensive medical treatment (over an intervention period of 8-10 weeks with 3-5 sessions/ week)
Group 2:
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
4 Years to 21 Years
Inclusion criteria
Inclusion criteria: - First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy - Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial - 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 (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language). - The patient is not in a terminal phase of the disease.
Exclusion criteria
Exclusion criteria: - Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery - Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre) - 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. - The patient (and the legal guardians) has/have insufficient knowledge of the respective national 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer-related fatigue Health-Related Quality of Life measured by the PedsQLTM 4.0 Generic Core Scales questionnaire and PedsQLTM 3.0. Cancer Modul time of measurement: - T0: pre-test - T0-T1: bi-weekly - T1: post-test - T2: 12 weeks after T1 - T3: after intensive cancer treatment - T4: 12 months after T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-Related Quality of Life, HRQoL Health-Related Quality of Life measured by the PedsQLTM 4.0 Generic Core Scales questionnaire and PedsQLTM 3.0. Cancer Modul time of measurement: T0: pre-test; T0-T1: bi-weekly; T1: post-test; T2: 12 weeks after T1; T3: after intensive cancer treatment; T4: 12 months after T2 2. Mental Health The Warwick–Edinburgh Mental Well-being Scale (WEMWBS) & WHO (Five) Well-Being Index time of measurement: T0: pre-test; T0-T1: bi-weekly; T1: post-test; T2: 12 weeks after T1; T3: after intensive cancer treatment; T4: 12 months after T2 3. Resilience (including stress reactivity, self efficacy and physical literacy) Stress reactivity measured by the Mainz Resilience Score for childhood cancer (MRScc) Resilience measured by the Brief Resilience Scale (BRS), CYRM-R (child and youth resilience measure) Self-efficacy measured by the General self-efficacy scale (GSE) time of measurement: T0: pre-test; T0-T1: bi-weekly; T1: post-test; T2: 12 weeks after T1; T3: after intensive cancer treatment; T4: 12 months after T2 4. Physical activity level and behaviour • Physical activity questionnaire: Modifed versions of the Recent Physical Activity Questionnaire (mRPAQ), Youth Physical Activity Questionnaire (mYPAQ), Children's Physical Activity Questionnaire (mCPAQ) - Parents Questionnaire • Semi-structured physical activity interview concerning motivational factors and barriers for physical activity time of measurement: pre-test; T0-T1: bi-weekly; T1: post-test; T2: 12 weeks after T1; T3: after intensive cancer treatment; T4: 12 months after T2 5. Exercise capacity/performance e.g. cardiopulmonary exercise testing, walking test, leg and arm muscle strength, muscle oxygenation, balance and flexibility evaluation, motor function, flexibility, posture control time of measurement: T0: pre-test; T1: post-test; T2: 12 weeks after T1 6. Body composition Bioelectrical impedance, skinfold, dual-energy absorptiometry (DEXA), anthropo | — |
Countries
Denmark, France, Germany, Italy, Slovenia, Spain, United Kingdom
Contacts
Public ContactJörg Faber
Zentrum für Kinder- und Jugendmedizin der Universitätsmedizin MainzAbteilung Pädiatrische Hämatologie/ Onkologie/ Hämostaseologie
Outcome results
None listed