SURfit - A Physical Activity Intervention for Childhood Cancer Survivors

University of Zurich151 enrolled

Overview

Exercise can play a major role to mitigate or even prevent late effects in cancer survivors, such as cardiovascular disease, obesity, osteoporosis, fatigue, depression, reduced quality of life, mental health and physical performance. The objective of this study is to assess the effect of an exercise program of 1 year on cardiovascular health, obesity and diabetes, osteoporosis, physical fitness, mental health and quality of life in childhood cancer survivors. The investigators will recruit childhood cancer survivors aged 16 years and above from three Swiss paediatric oncology clinics and randomize them into an intervention and a control group. The intervention group will be asked to increase physical activity for 1 year by at least 2.5 hours of intense physical activity weekly. Regular feedback will be given via a step counter, an online activity diary, and by the centre staff. The control group participants will keep their activity level constant. All participants will be seen after 3, 6 and 12 months to assess health and quality of life parameters over one year. After 1 year, the control group is offered to receive the same intervention to profit as well from an active lifestyle. If the program shows to be effective, a complete package will become available to interested centres treating paediatric cancer patients in Switzerland to promote exercise in all survivors. The program will allow clinicians without previous experience in exercise counselling to improve the care of their patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

151

Conditions

Late-effects of Childhood Cancer

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Registered in the Swiss Childhood Cancer Registry. * Age at cancer diagnosis \<16 years. * Diagnosed with a cancer classifiable within the International Classification of Childhood Cancer (ICCC-3) or diagnosed with a Langerhans Cell Histiocytosis. * Diagnosed and/or treated at the University Children's Hospital Basel, Cantonal Hospital of Aarau and/or Cantonal Hospital of Lucerne. * Survived ≥5 years since primary cancer diagnosis or any subsequent cancer event (relapse or further cancer diagnoses) * Age at the time of the study ≥16 years * Informed Consent as documented by signature Exclusion Criteria: * Participation in another clinical trial \<4 weeks prior to baseline assessment (eventually later re-enrolment) * Contradiction to one of the inclusion criteria mentioned above * Inability to exercise * Exercise potentially harmful * Women who are pregnant or breast feeding * Women who intend to become pregnant during the course of the study * Instable clinical condition (eventually later re-enrolment) * Under treatment for relapse or further cancer diagnoses * Cardiac arrhythmias under exercise (during baseline assessment or by history) * Diagnosis of diabetes \<3 months ago (eventually re-enrolment after 3 months if diabetes is under good control) * Detection of a clinical condition that needs immediate treatment during baseline assessments (eventually re-enrolment after 3 months if in stable clinical condition) * Planned relevant surgeries for the next 12 months * Major musculoskeletal injuries, fractures \<2 months ago (eventually later re-enrolment) * Recent change in medication that interfere with the parameters of the CVD risk score (primary outcome) \<1 month ago (eventually later re-enrolment) * \>4 hours of reported vigorous activities per week * Inability to follow the procedures and understand the intervention and assessments of the study e.g. due to cognitive impairment, language problems, psychological disorders etc.

Locations (1)

University Children's Hospital Basel (UKBB)

Basel, Basel, Switzerland

Outcomes

Primary Outcomes

Composite cardiovascular risk score [z-score]

summarized mean z-score of waist circumference, blood pressure, HOMA-IR, inverted high density lipoprotein cholesterol, triglycerides and cardiorespiratory fitness

Time frame: 12 months

Secondary Outcomes

Waist circumference [cm]

Time frame: 3, 6, and 12 months

Systolic and diastolic blood pressure [mmHg]

Time frame: 3, 6, and 12 months

Homeostasis Model Assessment Insulin Resistance (HOMA-IR)

calculated from insulin and glucose

Time frame: 6 and 12 months

HbA1C [mmol/mol]

Time frame: 6 and 12 months

Insulin resistance from response to oral glucose tolerance test (oGTT)

Assessment of fasting glucose \[mmol/l\] and insulin \[mIU/l\] and glucose 2 hours after drinking of a glucose solution

Time frame: 12 months

Inverted high-density lipoprotein cholesterol (HDL) [mmol/l]

Time frame: 6 and 12 months

Low-density lipoprotein cholesterol (LDL) [mmol/l]

Time frame: 6 and 12 months

Total cholesterol [mmol/l]

Time frame: 6 and 12 months

Triglycerides [mmol/l]

Time frame: 6 and 12 months

Body Mass Index (BMI) [z-score]

Calculated from height and weight

Time frame: 3, 6, and 12 months

Absolute [kg] and relative [%] body fat mass

Assessed with two methods: skinfold measurement (3, 6, and 12 months) and dual x-ray absorptiometry (DXA, 12 months only).

Time frame: 3, 6, and 12 months

Areal bone mineral density [g/cm2 and z-scores]

Bone mineral density for total body, lumbar spine, and femoral neck assessed with dual x-ray absorptiometry (DXA)

Time frame: 12 months

Bone mineral content [g/cm and z-scores]

Bone mineral content for total body, lumbar spine, and femoral neck assessed with dual x-ray absorptiometry (DXA)

Time frame: 12 months

Total cross sectional bone area [mm2 and z-scores]

Cross sectional area of the distal and proximal sites of radius and tibia assessed with peripheral quantitative computer tomography (pQCT)

Time frame: 12 months

Cortical cross sectional bone area [mm2 and z-scores]

Cross sectional area of the proximal site of radius and tibia assessed with peripheral quantitative computer tomography (pQCT)

Time frame: 12 months

Total and trabecular bone mineral density [g/cm3 and z-scores]

Bone mineral density of the distal site of radius and tibia assessed with peripheral quantitative computer tomography (pQCT)

Time frame: 12 months

Cortical bone mineral density [g/cm3 and z-scores]

Bone mineral density of the proximal site of radius and tibia assessed with peripheral quantitative computer tomography (pQCT)

Time frame: 12 months

Muscle cross-sectional area [cm2 and z-scores]

Muscle cross-sectional area of the proximal site of radius and tibia assessed with peripheral quantitative computer tomography (pQCT)

Time frame: 12 months

Peak oxygen uptake (VO2max) [ml/(kg*min) and % predicted]

Assessed with maximal spiroergometry test

Time frame: 6 and 12 months

Peak performance [watt/kg and % predicted]

Assessed with maximal spiroergometry test

Time frame: 6 and 12 months

Heart rate recovery [delta beats/min]

Assessed at the end of the maximal spiroergometry test: delta beats/min between peak heart rate and heart rate 1 minute post exercise.

Time frame: 6 and 12 months

Hand grip strength in the left and right hand [kg]

Assessed with a hydrolic hand grip dynamometer.

Time frame: 6 and 12 months

Leg strength and endurance [repetitions/min]

Assessed with the 1 minute sit-to-stand test

Time frame: 6 and 12 months

Total physical activity [counts/min]

Assessed by accelerometer

Time frame: 6 and 12 months

Moderate to vigorous physical activities [minutes/day]

Assessed by accelerometer

Time frame: 6 and 12 months

High impact activities with ground forces >3.9 G [n/day]

Assessed by accelerometer

Time frame: 6 and 12 month

Sedentary behaviour [minutes/day]

Assessed by accelerometer

Time frame: 6 and 12 months

Number of steps per day [steps/day]

Assessed by accelerometer

Time frame: 6 and 12 months

Health related quality of life [T-score with mean=50, standard deviation=10 and range=0-100]

Health related quality of life assessed by the self-reported questionnaire short form 36 (SF-36).

Time frame: 6 and 12 months

Psychological distress [T-score with mean=50, standard deviation=10 and range=0-100]

Psychological distress assessed by the self-reported questionnaire Brief Symptom Inventory (BSI).

Time frame: 6 and 12 months

Fatigue on a visual analogue scale (VAS) [mm]

Time frame: 3, 6 and 12 months

Fatigue

Fatigue assessed with the self-reported questionnaire Checklist of Individual Strength (CIS).

Time frame: 3, 6 and 12 months

Number of adverse events and serious adverse events [n]

Number of participants with adverse events and exercise related complications categorized into seriousness of the event (adverse event \[AE\] or severe adverse event \[SAE\]).

Time frame: 3, 6 and 12 months

Proportion of aimed physical activity reached [%]

Only intervention participants: compliance with intervention

Time frame: 12 months

Number of weeks where physical activity aim was reached [n/year]

Only intervention participants: compliance with intervention

Time frame: 12 months

Number of missing days in the online diary [n/year]

Only intervention participants: compliance with intervention

Time frame: 12 months

Data from ClinicalTrials.gov

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SURfit - A Physical Activity Intervention for Childhood Cancer Survivors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes