Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT05539794
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2022-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessment staff will be blinded to participant randomisation assignment. Yet, because of the nature of the study, it will not be possible to conceal the group assignment from the staff (i.e., fitness specialists, psycho-oncologists and nutritionists) involved in the different intervention (physical exercise and health counselling) sessions. Participants will be explicitly informed on the group to which they will be assigned as well as on the study hypotheses and will be reminded not to discuss their randomisation assignments with assessment staff and/or other patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will apply a two-arm RCT design, following the Consolidated Standards of Reporting Trials recommendations (1:1 randomisation ratio using a computer-generated random allocation sequence with a block on gender and main tumour type \\[leukaemias/solid tumours\\])'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left-ventricular (LV) function (LV ejection fraction) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined LV ejection fraction (unit = %)'}, {'measure': 'Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined LV ejection fraction (unit = %)'}, {'measure': 'Change in left-ventricular (LV) function (LV fractional shortening) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined LV fractional shortening (unit = %)'}, {'measure': 'Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]', 'description': 'Echocardiography-determined LV fractional shortening (unit = %)'}, {'measure': 'Change in global longitudinal strain (GLS) of the left ventricle from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined GLS (%)'}, {'measure': 'Change in global longitudinal strain (GLS) of the left ventricle from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined GLS (%)'}], 'secondaryOutcomes': [{'measure': "Change in 'clinic' arterial blood pressure from baseline to end of treatment", 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis', 'description': 'Arterial blood pressure (BP) (units = mmHg)'}, {'measure': "Change in 'clinic' arterial blood pressure from baseline to follow-up", 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Arterial blood pressure (BP) (units = mmHg)'}, {'measure': 'Change in serum lipid profile (cholesterol) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]', 'description': 'Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in serum lipid profile (cholesterol) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]', 'description': 'Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in serum lipid profile (triglycerides) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]', 'description': 'Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in serum lipid profile (triglycerides) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]', 'description': 'Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in adiposity index from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Waist-to-hip ratio (no units)'}, {'measure': 'Change in adiposity index from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)', 'description': 'Waist-to-hip ratio (no units)'}, {'measure': 'Change in DXA measures of lean mass from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'DXA-determined total lean mass (grams)'}, {'measure': 'Change in DXA measures of lean mass from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'DXA-determined total lean mass (grams)'}, {'measure': 'Change in DXA measures of fat mass from baseline to end of tratment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'DXA-determined total fat mass (grams)'}, {'measure': 'Change in DXA measures of fat mass from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'DXA-determined total fat mass (grams)'}, {'measure': 'Change in DXA measure of bone health from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'DXA-determined bone mineral density (unit = g/m2)'}, {'measure': 'Change in DXA measure of bone health from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)', 'description': 'DXA-determined bone mineral density (unit = g/m2)'}, {'measure': 'Change in cardiorespiratory fitness (VO2peak) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': "VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle-ergometer test (units = mL/kg/min)"}, {'measure': 'Change in cardiorespiratory fitness (VO2peak) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': "VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle-ergometer test (units = mL/kg/min)"}, {'measure': 'Change in muscle strength from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': '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).'}, {'measure': 'Change in muscle strength from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)', 'description': '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).'}, {'measure': 'Change in inspiratory muscle strength (PImax) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': '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.'}, {'measure': 'Change in inspiratory muscle strength (PImax) from baseline to follow-up', 'timeFrame': 'Assessed at three time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': '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.'}, {'measure': 'Survival from baseline to follow-up', 'timeFrame': 'Assessed from baseline (diagnosis) until 3 months after end of treatment (follow-up)', 'description': 'Number of days elapsed from diagnosis until the end of the study (or death, tumor recurrence, or transplant)'}, {'measure': 'Treatment tolerability from baseline to end of treatment', 'timeFrame': 'Assessed from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Number of days of treatment interruption/delay'}, {'measure': 'Change in clinical variables (days of hospitalization) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis', 'description': 'Total hospitalisation length (number of days)'}, {'measure': 'Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) from baseline to end of treatment', 'timeFrame': 'Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis.', 'description': 'Common Toxicity Criteria for Adverse Events \\[CTCAE, global score, 1 (low toxicity) to 5 (highest)\\]. Units: 1 to 5'}, {'measure': 'Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Common Toxicity Criteria for Adverse Events \\[CTCAE, global score, 1 (low toxicity) to 5 (highest\\])'}, {'measure': 'Change in metabolic markers (glucose) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis', 'description': 'Serum fasting glycaemia (mg/dL)'}, {'measure': 'Change in metabolic markers (glucose) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Serum fasting glycaemia (mg/dL)'}, {'measure': 'Metabolic markers (insulin) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Serum fasting insulinaemia (pmol/L)'}, {'measure': 'Metabolic markers (insulin) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Serum fasting insulinaemia (pmol/L)'}, {'measure': 'Change in metabolic markers (HOMA-IR) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)'}, {'measure': 'Change in metabolic markers (HOMA-IR) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)'}, {'measure': 'Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'High-sensitivity C-reactive protein (mg/L)'}, {'measure': 'Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'High-sensitivity C-reactive protein (mg/L)'}, {'measure': 'Change in plasma cardiometabolic-related targeted proteome from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': "Olink® cardiometabolic reagent kit, which measures 92 cardiometabolic related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)"}, {'measure': 'Change in plasma cardiometabolic-related targeted proteome from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (i.e., follow-up)', 'description': "Olink® cardiometabolic reagent kit, which measures 92 cardiometabolic related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)"}, {'measure': 'Change in gut microbiome (alpha-diversity) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'α-diversity'}, {'measure': 'Change in gut microbiome (alpha-diversity) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'α-diversity'}, {'measure': 'Change in gut microbiome (beta-diversity) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'beta-diversity'}, {'measure': 'Change in gut microbiome (beta-diversity) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Beta-diversity'}, {'measure': 'Change in gut microbiome (specific bacteria) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Changes in bacteria abundance'}, {'measure': 'Change in gut microbiome (specific bacteria) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Changes in bacteria abundance'}, {'measure': 'Change in Immune phenotype (lymphocyte subpopulations) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis', 'description': 'Lymphocyte subpopulations (%)'}, {'measure': 'Change in Immune phenotype (lymphocyte subpopulations) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Lymphocyte subpopulations (%)'}, {'measure': 'Change in Immune phenotype (natural killer (NK) cells) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'NK cell subsets (%)'}, {'measure': 'Change in Immune phenotype (NK cells) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'NK cell subsets (%)'}, {'measure': 'Change in Immune function from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'NK cell receptors'}, {'measure': 'Change in immune function from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'NK cell receptors'}, {'measure': 'Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to end of treatment', 'timeFrame': ': Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'NT-proBNP (units = pg/mL)'}, {'measure': 'Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': ': Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'NT-proBNP (units = pg/mL)'}, {'measure': 'Change in cardiac troponin I from baseline to end of treatment', 'timeFrame': ': Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Cardiac troponin I (units = ng/mL)'}, {'measure': 'Change in cardiac troponin I from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': ': Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Cardiac troponin I (units = ng/mL)'}, {'measure': 'Change in left-ventricular (LV) mass from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined LV mass (unit = grams)'}, {'measure': 'Change in left-ventricular (LV) mass from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined LV mass (unit = grams)'}, {'measure': 'Change in relative wall thickness (RWT) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined RWT (units = cm)'}, {'measure': 'Change in relative wall thickness (RWT) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined RWT (units = cm)'}, {'measure': 'Change in DXA measures of visceral adipose tissue (VAT) from baseline to end of tratment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'DXA-determined VAT (unit = grams)'}, {'measure': 'Change in DXA measures of visceral adipose tissue (VAT) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'DXA-determined VAT (grams)'}, {'measure': 'Change in serum lipid profile (apolipoprotein B) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in serum lipid profile (apolipoprotein B) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]', 'description': 'Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).'}, {'measure': 'Change in DXA measure of bone health from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'DXA-determined bone mineral content (unit = grams)'}, {'measure': 'Change in DXA measure of bone health from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)', 'description': 'DXA-determined bone mineral content (unit = grams)'}, {'measure': 'Change in handgrip strength from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).'}, {'measure': 'Change in handgrip strength from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)', 'description': 'Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).'}, {'measure': 'Change in interventricular septum thickness (IVS) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined IVS (units = mm)'}, {'measure': 'Change in interventricular septum thickness (IVS) from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined IVS (mm)'}, {'measure': 'Change in left-ventricular end-diastolic diameter (LVEDD) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined LVEDD (mL)'}, {'measure': 'Change in left-ventricular LV end-diastolic diameter (LVEDD) from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined LVEDD (mL)'}, {'measure': 'Change in left-ventricular posterior wall thickness (LVPW) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Echocardiography-determined LVPW (mm)'}, {'measure': 'Change in left-ventricular posterior wall thickness (LVPW) from baseline to 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)', 'description': 'Echocardiography-determined LVPW (mm)'}, {'measure': 'Change in functional mobility (Timed Up and Go (TUG)) test) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in TUG test (seconds)'}, {'measure': 'Change in functional mobility (Timed Up and Go (TUG)) test) from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in TUD test (seconds)'}, {'measure': 'Change in functional mobility (Timed Up and Down Stairs (TUDS)) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in TUDS test (units = seconds)'}, {'measure': 'Change in functional mobility (Timed Up and Down Stairs (TUDS) test) from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in TUDS test (seconds)'}, {'measure': 'Change in functional mobility (30-second chair stand test) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in 30-second chair stand test (unit = number of repetitions)'}, {'measure': 'Change in functional mobility (in 30-second chair stand test) from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Performance in in 30-second chair stand test (units = number of repetitions)'}, {'measure': 'Change in health-related quality of life (HRQoL) from baseline to end of treatment.', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.'}, {'measure': 'Change in health-related quality of life (HRQoL) from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.'}, {'measure': 'Change in fatigue from baseline to end of treatment.', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.'}, {'measure': 'Change in fatigue from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale) (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.'}, {'measure': 'Change in energy and nutrient intake from baseline to end of treatment.', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': "Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in %) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires"}, {'measure': 'Change in energy and nutrient intake from baseline 3 months after the end of treatment (follow-up)', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': "Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in %) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires"}, {'measure': 'Change in body mass index (BMI) from baseline to end of treatment', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)', 'description': 'BMI (weight (kg)/height squared (m2))'}, {'measure': 'Change in body mass index (BMI) from baseline to follow-up', 'timeFrame': 'Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)', 'description': 'BMI (weight (kg)/height squared (m2))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'lifestyle', 'cardiac function'], 'conditions': ['Adolescent Cancer']}, 'descriptionModule': {'briefSummary': "The investigators will study the effects of an inhospital exercise intervention combined with lifestyle--including diet--counselling along the duration of treatment (neoadjuvant \\[solid tumours\\]/intense chemotherapy \\[leukemias\\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial. In addition to usual care, the control group will be informed of the benefits of a healthy lifestyle. The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium, except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include inspiratory muscle training. Health counselling will include a psychological intervention based on motivational interviewing techniques, guidance by a nutritionist, and support sessions with survivors who will share their experiences with the study participants. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiography-determined variables, cardiac biomarkers, blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory markers, plasma proteome, gut microbiome, and immune function).", 'detailedDescription': "Background. Health promotion interventions are needed during adolescent cancer treatment to facilitate the acquisition of good health practices as patients transition to survivorship. Although meta-analytical evidence supports the health benefits of exercise in the context of childhood cancer, there is scant data focusing solely on adolescents.\n\nHypothesis and objectives. The investigators hypothesise that an inhospital exercise intervention combined with lifestyle counselling during treatment for adolescent cancer will provide several health benefits, particularly related to the cardiometabolic profile. Thus, the investigators will study the effects of an inhospital exercise intervention combined with lifestyle--including diet--counselling along the duration of treatment (neoadjuvant \\[solid tumours\\]/intense chemotherapy \\[leukaemias\\], expected median duration 5-6 months) on several health-related variables.\n\nSetting and Methods. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial (1:1 ratio randomisation with a block on gender and tumour type \\[leukaemias/lymphomas\\]). In addition to usual care, the control group will be informed of the benefits of a healthy lifestyle. The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium (3 sessions/week of aerobic and resistance exercises), except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include inspiratory muscle training (5 days/week). Health counselling will include a psychological intervention (1 session/week) based on motivational interviewing techniques, guidance by a nutritionist (2 sessions/month), and support sessions (1/month) with survivors (≥5-year survivorship) who will share their experiences with the study participants. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiographic variables, cardiometabolic biomarkers, blood pressure, blood lipids, dual-energy X-ray absorptiometry-determined body composition (fat \\[including visceral adipose tissue\\]/lean mass, bone mineral content/density), energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables (survival, treatment tolerability, hospitalisation length), and potential biological underpinnings of exercise multisystemic benefits (cardiometabolic and inflammatory biomarkers, gut microbiome, and immune function \\[lymphocyte subpopulations, natural killer cell cytotoxicity\\]) (secondary outcomes)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with a malignant extracranial tumour\n* Not having received any therapy--except surgery--at diagnosis\n* Adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2)\n* To understand Spanish language and provide written informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\<3 months\n* Comorbidity/acute condition contraindicating exercise practice'}, 'identificationModule': {'nctId': 'NCT05539794', 'acronym': 'HEALTHYADOL', 'briefTitle': 'Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Exercise and Lifestyle Intervention for Patients With Adolescent Cancer: a Randomised Controlled Trial (HEALTHYADOL)', 'orgStudyIdInfo': {'id': 'Universidad Europea de Madrid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention group will follow a physical exercise and lifestyle counselling program.', 'interventionNames': ['Behavioral: lifestyle and physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'lifestyle and physical exercise', 'type': 'BEHAVIORAL', 'description': "the intervention group will follow a physical exercise and health counselling intervention--see below.\n\nThe exercise program will be performed in the hospital gymnasium (3 supervised sessions/week of aerobic and muscle strength exercises) or in the patients' room (during phases of treatment-induced immunodepression, where isolation is needed to prevent infections). It will also include specific training of the respiratory ('inspiratory') muscles (e.g., diaphragm) on 5 days/week. The counselling program will include psychological (once weekly), nutritional (twice monthly), support (with survivors of adolescent cancer, twice/month) and educational (for relatives/caregivers, once monthly) sessions.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'UEM', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28670', 'city': 'Villaviciosa de Odón', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'phone': '+34661393101'}], 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}], 'centralContacts': [{'name': 'Alejandro Lucia', 'role': 'CONTACT', 'email': 'alejandro.lucia@universidadeuropea.es', 'phone': '+34661393101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As per Spanish regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}