A partially supervised physical activity program for adult and adolescent survivors of childhood cancer (SURfit): study design of a randomized controlled trial [NCT02730767]

Abstract

Background: Beyond survival of nowadays >80%, modern childhood cancer treatment strives to preserve long-term health and quality of life. However, the majority of today's survivors suffer from short- and long-term adverse effects such as cardiovascular and pulmonary diseases, obesity, osteoporosis, fatigue, depression, and reduced physical fitness and quality of life. Regular exercise can play a major role to mitigate or prevent such late-effects. Despite this, there are no data on the effects of regular exercise in childhood cancer survivors from randomized controlled trials (RCTs). Primary outcome of the current RCT is therefore the effect of a 12-months exercise program on a composite cardiovascular disease risk score in childhood cancer survivors. Secondary outcomes are single cardiovascular disease risk factors, glycaemic control, bone health, body composition, physical fitness, physical activity, quality of life, mental health, fatigue and adverse events (safety).

Methods: A total of 150 childhood cancer survivors aged ≥16 years and diagnosed ≥5 years prior to the study are recruited from Swiss paediatric oncology clinics. Following the baseline assessments patients are randomized 1:1 into an intervention and control group. Thereafter, they are seen at month 3, 6 and 12 for follow-up assessments. The intervention group is asked to add ≥2.5 h of intense physical activity/week, including 30 min of strength building and 2 h of aerobic exercises. In addition, they are told to reduce screen time by 25%. Regular consulting by physiotherapists, individual web-based activity diaries, and pedometer devices are used as motivational tools for the intervention group. The control group is asked to keep their physical activity levels constant.

Discussion: The results of this study will show whether a partially supervised exercise intervention can improve cardiovascular disease risk factors, bone health, body composition, physical activity and fitness, fatigue, mental health and quality of life in childhood cancer survivors. If the program will be effective, all relevant information of the SURfit physical activity intervention will be made available to interested clinics that treat and follow-up childhood cancer patients to promote exercise in their patients.

Trial registration: Prospectively registered in clinicaltrials.gov [ NCT02730767 ], registration date: 10.12.2015.

Keywords: Body composition; Bone health; Cardiovascular disease; Childhood cancer survivors; Exercise intervention; Late-effects; Physical activity; Physical fitness; Quality of life; Randomized controlled trial.

Fig. 1

SURfit study design. Shows the general design and procedure of the SURfit study. All visits of T0, T3, T6 and T12 are at the University Children’s Hospital Basel (UKBB) including a visit at the Bone Research Unit of the University Hospital Basel (USB) to perform the DXA and pQCT scans (T0a and T12a). After one year of trial, participants of the control intervention who wish to, can receive the same personalized exercise counselling with motivational tools but no personal follow-up coaching. Participants of the intervention group will hopefully continue their training without supervision of the study team but still having access to the motivational tools of the study. Abbreviations: DXA, dual x-ray absorptiometry; mt, months; oGTT, oral glucose tolerance test; pQCT, peripheral quantitative computed tomography; SCCR, Swiss Childhood Cancer Registry; T0a, initial baseline visit; T0b, second visit for baseline assessments; T3, assessment after 3 months; T6a and T6b, first and second visit of assessments after 6 months; T12a and T12b, first and second visit of assessments after 12 months