NCT02730767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

December 10, 2015

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (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

    12 months

Secondary Outcomes (36)

  • Waist circumference [cm]

    3, 6, and 12 months

  • Systolic and diastolic blood pressure [mmHg]

    3, 6, and 12 months

  • Homeostasis Model Assessment Insulin Resistance (HOMA-IR)

    6 and 12 months

  • HbA1C [mmol/mol]

    6 and 12 months

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

    12 months

  • +31 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Partially 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.

Behavioral: partially supervised exercise intervention

Control Group

NO INTERVENTION

The 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.

Interventions

Also known as: physical activity intervention
Intervention Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participation in another clinical trial \<4 weeks prior to baseline assessment (eventually later re-enrolment)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Basel (UKBB)

Basel, Basel, 4056, Switzerland

Location

Related Publications (8)

  • 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.

    PMID: 37653075BACKGROUND
  • 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.

    PMID: 38315522BACKGROUND
  • 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.

    PMID: 33405260BACKGROUND
  • 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.

    PMID: 37199378BACKGROUND
  • 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.

    PMID: 35913755BACKGROUND
  • 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.

    PMID: 32167159BACKGROUND
  • 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.

    PMID: 29207962BACKGROUND
  • 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.

Study Officials

  • Nicolas X von der Weid, Prof, MD

    University Children's Hospital Basel, UKBB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

April 6, 2016

Study Start

August 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations