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Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined LV ejection fraction (unit = %)
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Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Echocardiography-determined LV fractional shortening (unit = %)
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Change in global longitudinal strain (GLS) of the left ventricle from baseline to 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined GLS (%)
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Change in 'clinic' arterial blood pressure from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Arterial blood pressure (BP) (units = mmHg)
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Change in 'clinic' arterial blood pressure from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Arterial blood pressure (BP) (units = mmHg)
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Change in serum lipid profile (cholesterol) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in serum lipid profile (cholesterol) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in serum lipid profile (triglycerides) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in serum lipid profile (triglycerides) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in adiposity index from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Waist-to-hip ratio (no units)
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Change in adiposity index from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)
Waist-to-hip ratio (no units)
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Change in DXA measures of lean mass from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
DXA-determined total lean mass (grams)
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Change in DXA measures of lean mass from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
DXA-determined total lean mass (grams)
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Change in DXA measures of fat mass from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
DXA-determined total fat mass (grams)
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Change in DXA measures of fat mass from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
DXA-determined total fat mass (grams)
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Change in DXA measure of bone mineral density of the total body (less head) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
DXA-determined subtotal bone mineral density (unit = g/cm2)
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Change in DXA measure of bone mineral density of the total body (less head) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)
DXA-determined subtotal bone mineral density (unit = g/cm2)
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Change in cardiorespiratory fitness (VO2peak) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
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Change in cardiorespiratory fitness (VO2peak) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank -for those participants missing a lower limb- ergometer test (units = mL/kg/min).
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Change in muscle strength from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press, as well as for seated lateral row, lateral pull down and knee extension (units = kg).
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Change in muscle strength from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)
The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press, as well as for seatead lateral row, lateral pull down and knee extension (units = kg).
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Change in inspiratory muscle strength (PImax) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of ≥1 min-duration) taken.
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Change in inspiratory muscle strength (PImax) from baseline to follow-up
Time frame: Assessed at three time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of ≥1 min-duration) taken.
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Survival from baseline to follow-up
Time frame: Assessed from baseline (diagnosis) until 3 months after end of treatment (follow-up)
Number of days elapsed from diagnosis until the end of the study (or death, tumor recurrence, or transplant)
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Treatment tolerability from baseline to end of treatment
Time frame: Assessed from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Number of days of treatment interruption/delay
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Change in clinical variables (days of hospitalization) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Total hospitalisation length (number of days)
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Change in clinical variables (global score of Common Terminology Criteria for Adverse Events [CTCAE]) from baseline to end of treatment
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis.
Common Terminology Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest)]
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Change in clinical variables (global score of Common Terminology Criteria for Adverse Events [CTCAE]) from baseline to follow-up
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment (follow-up)
Common Terminology Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest])
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Change in metabolic markers (glucose) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Serum fasting glycaemia (mg/dL)
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Change in metabolic markers (glucose) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Serum fasting glycaemia (mg/dL)
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Change in metabolic markers (insulin) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Serum fasting insulinaemia (pmol/L)
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Change in metabolic markers (insulin) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Serum fasting insulinaemia (pmol/L)
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Change in metabolic markers (HOMA-IR) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
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Change in metabolic markers (HOMA-IR) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
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Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
High-sensitivity C-reactive protein (mg/L)
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Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
High-sensitivity C-reactive protein (mg/L)
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Change in plasma cardiovascular-related targeted proteome from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Olink® cardiovascular II reagent kit, which measures 92 cardiovascular related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)
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Change in plasma cardiovascular-related targeted proteome from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (i.e., follow-up)
Olink® cardiovascular II reagent kit, which measures 92 cardiovascular related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)
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Change in gut microbiome (alpha-diversity) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
-
Change in gut microbiome (alpha-diversity) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
-
Change in gut microbiome (beta-diversity) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
-
Change in gut microbiome (beta-diversity) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
-
Change in gut microbiome (specific bacteria) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Changes in bacteria abundance
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Change in gut microbiome (specific bacteria) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Changes in bacteria abundance
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Change in Immune phenotype (lymphocyte subpopulations) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Lymphocyte subpopulations (%)
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Change in Immune phenotype (lymphocyte subpopulations) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Lymphocyte subpopulations (%)
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Change in Immune phenotype (natural killer (NK) cells) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
-
Change in Immune phenotype (NK cells) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
-
Change in Immune function from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
-
Change in immune function from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
-
Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to end of treatment
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
NT-proBNP (units = pg/mL)
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Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to 3 months after the end of treatment (follow-up)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
NT-proBNP (units = pg/mL)
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Change in cardiac troponin I from baseline to end of treatment
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Cardiac troponin I (units = ng/mL)
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Change in cardiac troponin I from baseline to 3 months after the end of treatment (follow-up)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Cardiac troponin I (units = ng/mL)
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Change in left-ventricular (LV) mass from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Echocardiography-determined LV mass (unit = grams)
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Change in left-ventricular (LV) mass from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined LV mass (unit = grams)
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Change in relative wall thickness (RWT) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Echocardiography-determined RWT (units = cm)
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Change in relative wall thickness (RWT) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined RWT (units = cm)
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Change in DXA measures of visceral adipose tissue (VAT) from baseline to end of tratment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
DXA-determined VAT (unit = grams)
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Change in DXA measures of visceral adipose tissue (VAT) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
DXA-determined VAT (grams)
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Change in serum lipid profile (apolipoprotein B) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in serum lipid profile (apolipoprotein B) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).
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Change in handgrip strength from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).
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Change in handgrip strength from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)
Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).
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Change in interventricular septum thickness (IVS) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Echocardiography-determined IVS (units = mm)
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Change in interventricular septum thickness (IVS) from baseline to 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined IVS (mm)
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Change in left-ventricular end-diastolic diameter (LVEDD) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Echocardiography-determined LVEDD (mL)
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Change in left-ventricular LV end-diastolic diameter (LVEDD) from baseline to 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined LVEDD (mL)
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Change in left-ventricular posterior wall thickness (LVPW) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Echocardiography-determined LVPW (mm)
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Change in left-ventricular posterior wall thickness (LVPW) from baseline to 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Echocardiography-determined LVPW (mm)
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Change in functional mobility (Timed Up and Go (TUG)) test) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in TUG test (seconds)
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Change in functional mobility (Timed Up and Go (TUG)) test) from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in TUG test (seconds)
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Change in functional mobility (Timed Up and Down Stairs (TUDS)) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in TUDS test (units = seconds)
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Change in functional mobility (Timed Up and Down Stairs (TUDS) test) from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in TUDS test (seconds)
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Change in functional mobility (30-second chair stand test) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in 30-second chair stand test (unit = number of repetitions)
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Change in functional mobility (in 30-second chair stand test) from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Performance in in 30-second chair stand test (units = number of repetitions)
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Change in health-related quality of life (HRQoL) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Patient's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in health-related quality of life (HRQoL) from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Patient's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in fatigue from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Patient's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in fatigue from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Patient's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in energy and nutrient intake from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in grams) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires
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Change in energy and nutrient intake from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in grams) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires
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Change in body mass index (BMI) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
BMI (weight (kg)/height squared (m2))
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Change in body mass index (BMI) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)
BMI (weight (kg)/height squared (m2))
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Change in DXA measure of bone mineral density of the femoral neck from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment).
DXA-determined bone mineral density of the femoral neck (unit = g/cm2)
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Change in DXA measure of bone mineral density of the femoral neck from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)
DXA-determined total bone mineral density of the femoral neck (unit = g/cm2)
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Change in peak power output (also known was 'peak work capacity') from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Peak power output will be determined using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
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Change in in peak power output (also known was 'peak work capacity') from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Peak power output will be determined using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
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Change in the power output eliciting the 'ventilatory threshold' from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)]
The ventilatory threshold will be visually determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
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Change in the power output eliciting the 'ventilatory threshold' from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
The ventilatory threshold will be visually determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
-
Change in health-related quality of life (HRQoL) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Parent's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
-
Change in health-related quality of life (HRQoL) from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Parent's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in fatigue from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Parent's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in fatigue from baseline 3 months after the end of treatment (follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Parents' version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
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Change in the range of movement (ROM) of the ankle in the relaxed position from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Ankle's ROM in the relaxed position will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
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Change in the range of movement (ROM) of the ankle in the relaxed position from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow- up)
Ankle's ROM in the relaxed position will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
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Change in the range of movement (ROM) of the ankle at dorsiflexion from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Ankle's ROM at dorsiflexion will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
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Change in the range of movement (ROM) of the ankle at dorsiflexion from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Ankle's ROM at dorsiflexion will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
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Change in the physical activity levels from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Physical activity levels will be measured with the 'Youth Activity Profile' (YAP) questionnaire
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Change in the physical activity levels from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Physical activity levels will be measured with the 'Youth Activity Profile' (YAP) questionnaire
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Change in the physical activity levels from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Physical activity levels will be measured with the 'Assessment of Physical Activity Levels' (APAL) questionnaire (units = score from 5 to 20)
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Change in the physical activity levels from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Physical activity levels will be measured with the 'Assessment of Physical Activity Levels' (APAL) questionnaire (units = score from 5 to 20)
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Change in the number of viral/bacterial/fungal infections from baseline to end of treatment
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
The number of viral/bacterial/fungal infections will be retrieved from medical records
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Change in the number of viral/bacterial/fungal infections from baseline to follow-up
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
The number of viral/bacterial/fungal infections will be retrieved from medical records
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Change in metabolic markers (glycated hemoglobin) from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Serum fasting glycated hemoglobin (mmol/mol)
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Change in metabolic markers (glycated hemoglobin) from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Serum fasting glycated hemoglobin (mmol/mol)
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Change in left-ventricular (LV) hypertrophy from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Age-specific >95th percentile for LV mass
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Change in left-ventricular (LV) hypertrophy from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Age-specific >95th percentile for LV mass
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Change in VO2 at the ventilatory threshold from baseline to end of treatment
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
VO2 at the ventilatory threshold will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
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Change in VO2 at the ventilatory threshold from baseline to follow-up
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
VO2 at the ventilatory threshold will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
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Change in toxicity grade from baseline to end of treatment
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Toxicity grade will be assessed using the formula from Langlais et al (2022), where using the 5 adverse events of higher grade, provides a score from 5 (more toxicity) to 0 (less toxicity)
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Change in toxicity grade from baseline to follow-up
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
Toxicity grade will be assessed using the formula from Langlais et al (2022), where using the 5 adverse events of higher grade, provides a score from 5 (more toxicity) to 0 (less toxicity)
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Change in the duration of viral/bacterial/fungal infections from baseline to end of treatment
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
The duration of viral/bacterial/fungal infections will be retrieved from medical records
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Change in the duration of viral/bacterial/fungal infections from baseline to follow-up
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
The duration of viral/bacterial/fungal infections will be retrieved from medical records
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Adherence to the exercise intervention from baseline to end of treatment
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
The number of attended exercise sessions
