Clinical trial NCT02730767: SURfit - A Physical Activity Intervention for Childhood Cancer Survivors
Official title: Effects of a 1-year Partially Supervised Exercise Program in Childhood Cancer Survivors - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Late-effects of Childhood Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2016-04-06
Enrollment: 151
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite cardiovascular risk score [z-score]
timeFrame: 12 months
Secondary outcomes:
measure: Waist circumference [cm]
timeFrame: 3, 6, and 12 months
measure: Systolic and diastolic blood pressure [mmHg]
timeFrame: 3, 6, and 12 months
measure: Homeostasis Model Assessment Insulin Resistance (HOMA-IR)
timeFrame: 6 and 12 months
measure: HbA1C [mmol/mol]
timeFrame: 6 and 12 months
measure: Insulin resistance from response to oral glucose tolerance test (oGTT)
timeFrame: 12 months
measure: Inverted high-density lipoprotein cholesterol (HDL) [mmol/l]
timeFrame: 6 and 12 months
measure: Low-density lipoprotein cholesterol (LDL) [mmol/l]
timeFrame: 6 and 12 months
measure: Total cholesterol [mmol/l]
timeFrame: 6 and 12 months
measure: Triglycerides [mmol/l]
timeFrame: 6 and 12 months
measure: Body Mass Index (BMI) [z-score]
timeFrame: 3, 6, and 12 months
measure: Absolute [kg] and relative [%] body fat mass
timeFrame: 3, 6, and 12 months
measure: Areal bone mineral density [g/cm2 and z-scores]
timeFrame: 12 months
measure: Bone mineral content [g/cm and z-scores]
timeFrame: 12 months
measure: Total cross sectional bone area [mm2 and z-scores]
timeFrame: 12 months
measure: Cortical cross sectional bone area [mm2 and z-scores]
timeFrame: 12 months
measure: Total and trabecular bone mineral density [g/cm3 and z-scores]
timeFrame: 12 months
measure: Cortical bone mineral density [g/cm3 and z-scores]
timeFrame: 12 months
measure: Muscle cross-sectional area [cm2 and z-scores]
timeFrame: 12 months
measure: Peak oxygen uptake (VO2max) [ml/(kg*min) and % predicted]
timeFrame: 6 and 12 months
measure: Peak performance [watt/kg and % predicted]
timeFrame: 6 and 12 months
measure: Heart rate recovery [delta beats/min]
timeFrame: 6 and 12 months
measure: Hand grip strength in the left and right hand [kg]
timeFrame: 6 and 12 months
measure: Leg strength and endurance [repetitions/min]
timeFrame: 6 and 12 months
measure: Total physical activity [counts/min]
timeFrame: 6 and 12 months
measure: Moderate to vigorous physical activities [minutes/day]
timeFrame: 6 and 12 months
measure: High impact activities with ground forces >3.9 G [n/day]
timeFrame: 6 and 12 month
measure: Sedentary behaviour [minutes/day]
timeFrame: 6 and 12 months
measure: Number of steps per day [steps/day]
timeFrame: 6 and 12 months
measure: Health related quality of life [T-score with mean=50, standard deviation=10 and range=0-100]
timeFrame: 6 and 12 months
measure: Psychological distress [T-score with mean=50, standard deviation=10 and range=0-100]
timeFrame: 6 and 12 months
measure: Fatigue on a visual analogue scale (VAS) [mm]
timeFrame: 3, 6 and 12 months
measure: Fatigue
timeFrame: 3, 6 and 12 months
measure: Number of adverse events and serious adverse events [n]
timeFrame: 3, 6 and 12 months
measure: Proportion of aimed physical activity reached [%]
timeFrame: 12 months
measure: Number of weeks where physical activity aim was reached [n/year]
timeFrame: 12 months
measure: Number of missing days in the online diary [n/year]
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel (UKBB)
Study officials:
affiliation: University Children's Hospital Basel, UKBB
name: Nicolas X von der Weid, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rueegg CS, Zurcher SJ, Schindera C, Jung R, Deng WH, Banteli I, Schaeff J, Hebestreit H, von der Weid NX, Kriemler S. Effect of a 1-year physical activity intervention on cardiovascular health in long-term childhood cancer survivors-a randomised controlled trial (SURfit). Br J Cancer. 2023 Oct;129(8):1284-1297. doi: 10.1038/s41416-023-02410-y. Epub 2023 Aug 31.
citation: Deng WH, Zurcher SJ, Schindera C, Jung R, Hebestreit H, Banteli I, Bologna K, von der Weid NX, Kriemler S, Rueegg CS. Effect of a 1-year physical activity intervention on quality of life, fatigue, and distress in adult childhood cancer survivors-A randomized controlled trial (SURfit). Cancer. 2024 May 15;130(10):1869-1883. doi: 10.1002/cncr.35207. Epub 2024 Feb 5.
citation: Schindera C, Zurcher SJ, Jung R, Boehringer S, Balder JW, Rueegg CS, Kriemler S, von der Weid NX. Physical fitness and modifiable cardiovascular disease risk factors in survivors of childhood cancer: A report from the SURfit study. Cancer. 2021 May 15;127(10):1690-1698. doi: 10.1002/cncr.33351. Epub 2021 Jan 6.
citation: Jung R, Zurcher SJ, Schindera C, Braun J, Deng WH, von der Weid NX, Rueegg CS, Kriemler S. Adherence and contamination in a 1-year physical activity program in childhood cancer survivors: A report from the SURfit study. Cancer Med. 2023 Jul;12(13):14731-14741. doi: 10.1002/cam4.6096. Epub 2023 May 18.
citation: Jung R, Zurcher SJ, Schindera C, Eser P, Meier C, Schai A, Braun J, Deng WH, Hebestreit H, Neuhaus C, Schaeff J, Rueegg CS, von der Weid NX, Kriemler S. Effect of a physical activity intervention on lower body bone health in childhood cancer survivors: A randomized controlled trial (SURfit). Int J Cancer. 2023 Jan 15;152(2):162-171. doi: 10.1002/ijc.34234. Epub 2022 Aug 26.
citation: Zurcher SJ, Jung R, Monnerat S, Schindera C, Eser P, Meier C, Rueegg CS, von der Weid NX, Kriemler S. High impact physical activity and bone health of lower extremities in childhood cancer survivors: A cross-sectional study of SURfit. Int J Cancer. 2020 Oct 1;147(7):1845-1854. doi: 10.1002/ijc.32963. Epub 2020 Mar 25.
citation: Rueegg CS, Kriemler S, Zuercher SJ, Schindera C, Renner A, Hebestreit H, Meier C, Eser P, von der Weid NX. A partially supervised physical activity program for adult and adolescent survivors of childhood cancer (SURfit): study design of a randomized controlled trial [NCT02730767]. BMC Cancer. 2017 Dec 5;17(1):822. doi: 10.1186/s12885-017-3801-8.
citation: Schindera C, Usemann J, Zuercher SJ, Jung R, Kasteler R, Frauchiger B, Naumann G, Rueegg CS, Latzin P, Kuehni CE, von der Weid NX. Pulmonary Dysfunction after Treatment for Childhood Cancer. Comparing Multiple-Breath Washout with Spirometry. Ann Am Thorac Soc. 2021 Feb;18(2):281-289. doi: 10.1513/AnnalsATS.202003-211OC.