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Late-effects of Childhood CancerSURfitNCT02730767

SURfit - A Physical Activity Intervention for Childhood Cancer Survivors

A study testing partially supervised exercise intervention in people with Late-effects of Childhood Cancer, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Late-effects of Childhood Cancer
What is being tested?
partially supervised exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteSwitzerland
Study dates
Aug 2015to Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Children's Hospital Basel (UKBB)

    Basel, Basel, 4056

Other trials in Switzerland

About this study

Official title: Effects of a 1-year Partially Supervised Exercise Program in Childhood Cancer Survivors - a Randomized Controlled Trial

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.

Being tested
partially supervised exercise intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • partially supervised exercise interventionBehavioural

    Also called physical activity intervention

Study groups in NCT02730767
Study groupRoleWhat they receive
Intervention GroupExperimentalPartially supervised exercise intervention: Survivors in the intervention group will be asked to add at least 2.5 hours of intense physical activities per week. These should include at least 30 min of strength building exercises and 2 hours of aerobic exercises per week. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.
Receives: Behavioral: partially supervised exercise intervention
Control GroupNo interventionThe control group will keep their physical activity level constant over the 1 year of the study. Thereafter, they will have the opportunity to receive the same intervention than the intervention group had received (off-trial) to benefit in the same way from an active lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (36)
  1. Waist circumference [cm]

    Measured: 3, 6, and 12 months

  2. Systolic and diastolic blood pressure [mmHg]

    Measured: 3, 6, and 12 months

  3. Homeostasis Model Assessment Insulin Resistance (HOMA-IR)

    calculated from insulin and glucose

    Measured: 6 and 12 months

  4. HbA1C [mmol/mol]

    Measured: 6 and 12 months

  5. 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

    Measured: 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

  8. Total cholesterol [mmol/l]

    Measured: 6 and 12 months

  9. Triglycerides [mmol/l]

    Measured: 6 and 12 months

  10. Body Mass Index (BMI) [z-score]

    Calculated from height and weight

    Measured: 3, 6, and 12 months

  11. 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).

    Measured: 3, 6, and 12 months

  12. 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)

    Measured: 12 months

  13. 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)

    Measured: 12 months

  14. 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)

    Measured: 12 months

  15. 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)

    Measured: 12 months

  16. 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)

    Measured: 12 months

  17. 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)

    Measured: 12 months

  18. 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)

    Measured: 12 months

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

    Assessed with maximal spiroergometry test

    Measured: 6 and 12 months

  20. Peak performance [watt/kg and % predicted]

    Assessed with maximal spiroergometry test

    Measured: 6 and 12 months

  21. 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.

    Measured: 6 and 12 months

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

    Assessed with a hydrolic hand grip dynamometer.

    Measured: 6 and 12 months

  23. Leg strength and endurance [repetitions/min]

    Assessed with the 1 minute sit-to-stand test

    Measured: 6 and 12 months

  24. Total physical activity [counts/min]

    Assessed by accelerometer

    Measured: 6 and 12 months

  25. Moderate to vigorous physical activities [minutes/day]

    Assessed by accelerometer

    Measured: 6 and 12 months

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

    Assessed by accelerometer

    Measured: 6 and 12 month

  27. Sedentary behaviour [minutes/day]

    Assessed by accelerometer

    Measured: 6 and 12 months

  28. Number of steps per day [steps/day]

    Assessed by accelerometer

    Measured: 6 and 12 months

  29. 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).

    Measured: 6 and 12 months

  30. 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).

    Measured: 6 and 12 months

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

    Measured: 3, 6 and 12 months

  32. Fatigue

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

    Measured: 3, 6 and 12 months

  33. 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]).

    Measured: 3, 6 and 12 months

  34. Proportion of aimed physical activity reached [%]

    Only intervention participants: compliance with intervention

    Measured: 12 months

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

    Only intervention participants: compliance with intervention

    Measured: 12 months

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

    Only intervention participants: compliance with intervention

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730767
Sponsor's protocol ID
SURfit
Acronym
SURfit
Status last verified
Apr 2025
First submitted
10 Dec 2015
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35913755
  • 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.

    PubMed 32167159
  • 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.

    PubMed 29207962
  • 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.

    PubMed 37653075
  • 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.

    PubMed 38315522
  • 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.

    PubMed 33405260
  • 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.

    PubMed 37199378
  • 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.

    PubMed 32877212

Questions about this trial

What is this clinical trial studying?

A study testing partially supervised exercise intervention in people with Late-effects of Childhood Cancer, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite cardiovascular risk score [z-score] (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730767, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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