Design of a randomized controlled trial of physical training and cancer (Phys-Can) – the impact of exercise intensity on cancer related fatigue, quality of life and disease outcome

Abstract

BackgroundCancer-related fatigue is a common problem in persons with cancer, influencing health-related quality of life and causing a considerable challenge to society. Current evidence supports the beneficial effects of physical exercise in reducing fatigue, but the results across studies are not consistent, especially in terms of exercise intensity. It is also unclear whether use of behaviour change techniques can further increase exercise adherence and maintain physical activity behaviour. This study will investigate whether exercise intensity affects fatigue and health related quality of life in persons undergoing adjuvant cancer treatment. In addition, to examine effects of exercise intensity on mood disturbance, adherence to oncological treatment, adverse effects from treatment, activities of daily living after treatment completion and return to work, and behaviour change techniques effect on exercise adherence. We will also investigate whether exercise intensity influences inflammatory markers and cytokines, and whether gene expressions following training serve as mediators for the effects of exercise on fatigue and health related quality of life.Methods/designSix hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 × 2 factorial design to following conditions; A) individually tailored low-to-moderate intensity exercise with or without behaviour change techniques or B) individually tailored high intensity exercise with or without behaviour change techniques. The training consists of both resistance and endurance exercise sessions under the guidance of trained coaches. The primary outcomes, fatigue and health related quality of life, are measured by self-reports. Secondary outcomes include fitness, mood disturbance, adherence to the cancer treatment, adverse effects, return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines and gene expression.DiscussionThe study will contribute to our understanding of the value of exercise and exercise intensity in reducing fatigue and improving health related quality of life and, potentially, clinical outcomes. The value of behaviour change techniques in terms of adherence to and maintenance of physical exercise behaviour in persons with cancer will be evaluated.Trial registration NCT02473003, October, 2014.

Exercise: A positive feature on functioning in daily life during cancer treatment – Experiences from the Phys-Can study

“…The participants were recruited from the Phys-Can study, a Swedish multicentre randomized controlled trial evaluating the effects of exercise with high or low-to-moderate intensity on cancer-related fatigue (Berntsen et al, 2017). The Phys-Can study recruited participants from three university hospitals and included individuals ≥18 years of age, diagnosed with breast cancer, colorectal cancer or prostate cancer, scheduled for curative chemotherapy and/or radiotherapy and/or endocrine therapy.…”

“…heart failure, chronic obstructive pulmonary disease, orthopaedic conditions or neurological disorders). (Berntsen et al, 2017). The intervention lasted for six months during cancer treatment and consisted of homebased monitored endurance training together with twice-weekly supervised resistance training at a gym with other participants.…”

The Phys-Can study: meaningful and challenging - supervising physical exercise in a community-based setting for persons undergoing curative oncological treatment

“…The design of Phys-Can has been reported elsewhere (Berntsen et al, 2017). Briefly, the persons included in the Phys-Can study hereinafter referred to as participants were randomly assigned to a 6-month exercise program including low-to-moderate or high intensity exercise, with or without BCTs.…”

“…Phys-Can (Physical Training and Cancer) was a Swedish multicenter randomized controlled trial aiming to compare the effects of low-to-moderate versus high intensity exercise with or without behavior change techniques (BCTs) on cancer-related fatigue during curative oncological treatment (i.e. chemotherapy and/ or radiotherapy and/or endocrine therapy due to breast, colorectal or prostate cancer) (Berntsen et al, 2017). Physical therapists and personal trainers supervised the exercise, which was performed at public gyms, and thus Phys-Can provides a unique opportunity to explore the views on exercise supervision among professionals who deliver exercise programs in a community-based setting during treatment.…”

Effect of exercise on cancer-related fatigue: A systematic review

“…Cancer is caused by internal factors, such as inherited genetic mutations, hormones, and immune conditions and external factors, such as tobacco, infectious organisms, and an unhealthy diet; in 2012, USA registered about 5% of all cancers were caused by inactivity (Parkin et al, 2011). Furthermore, Cancer was estimated to have resulted in 208.3 million disability-adjusted-life-years in 2015 (Bernsten et al, 2017). One of these is cancer-related fatigue (CRF) (Akechi et al, 1999).…”