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

Linköpings universitet, Avdelningen för omvårdnad Linköpings universitet, Medicinska fakulteten Region Östergötland, Onkologiska kliniken US Uppsala University, Sweden; University of Agder, Norway Netherlands Cancer Institute, Netherlands Vrije University of Amsterdam Medical Centre, Netherlands; Vrije University of Amsterdam Medical Centre, Netherlands Uppsala University, Sweden Lund University, Sweden Copenhagen University Hospital, Denmark Uppsala University, Sweden Uppsala University, Sweden Uppsala University, Sweden Norwegian School Sport Science, Norway University of Leeds, England Uppsala University, Sweden Uppsala University, Sweden; University of Agder, Norway BIOMED CENTRAL LTD 2017

Background: Cancer-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/design: Six hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 x 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, cyt
Funding Agencies|Swedish Cancer Society [CAN 2012/621, CAN 2012/631, CAN 2015/414]; Swedish Research Council [K2014-99X]; Nordic Cancer Union; World Cancer Research Fund (WCRF UK); Wereld Kanker Onderzoek Fonds (WKOF), World Cancer Research Fund International grant [2016/1635]

Cancer; Physical exercise; Behaviour change techniques; Fatigue; Biological mechanism; Quality of life; Randomized controlled trial; Cancer and Oncology; Cancer och onkologi; Article in journal; info:eu-repo/semantics/article; text

10.1186.s12885-017-3197-5

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English

UPE oai:DiVA.org:liu-136579
doi:10.1186/s12885-017-3197-5
PMID 28347291
ISI:000397448100002
1233453890

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