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

Sveinung Berntsen, Neil K Aaronson, Laurien Buffart, Sussanne Börjeson, Ingrid Demmelmaier, Maria Hellbom, Pernille Hojman, Helena Igelström, Birgitta Johansson, Ronnie Pingel, Truls Raastad, Galina Velikova, Pernilla Åsenlöf, Karin Nordin

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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 × 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.

DISCUSSION: The 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.

Original languageEnglish
Pages (from-to)218
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - 27 Mar 2017

Cite this

Berntsen, Sveinung ; Aaronson, Neil K ; Buffart, Laurien ; Börjeson, Sussanne ; Demmelmaier, Ingrid ; Hellbom, Maria ; Hojman, Pernille ; Igelström, Helena ; Johansson, Birgitta ; Pingel, Ronnie ; Raastad, Truls ; Velikova, Galina ; Åsenlöf, Pernilla ; Nordin, Karin. / 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. In: BMC Cancer. 2017 ; Vol. 17, No. 1. pp. 218.
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abstract = "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 × 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.DISCUSSION: The 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.",
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Berntsen, S, Aaronson, NK, Buffart, L, Börjeson, S, Demmelmaier, I, Hellbom, M, Hojman, P, Igelström, H, Johansson, B, Pingel, R, Raastad, T, Velikova, G, Åsenlöf, P & Nordin, K 2017, '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' BMC Cancer, vol. 17, no. 1, pp. 218. https://doi.org/10.1186/s12885-017-3197-5

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. / Berntsen, Sveinung; Aaronson, Neil K; Buffart, Laurien; Börjeson, Sussanne; Demmelmaier, Ingrid; Hellbom, Maria; Hojman, Pernille; Igelström, Helena; Johansson, Birgitta; Pingel, Ronnie; Raastad, Truls; Velikova, Galina; Åsenlöf, Pernilla; Nordin, Karin.

In: BMC Cancer, Vol. 17, No. 1, 27.03.2017, p. 218.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - Berntsen, Sveinung

AU - Aaronson, Neil K

AU - Buffart, Laurien

AU - Börjeson, Sussanne

AU - Demmelmaier, Ingrid

AU - Hellbom, Maria

AU - Hojman, Pernille

AU - Igelström, Helena

AU - Johansson, Birgitta

AU - Pingel, Ronnie

AU - Raastad, Truls

AU - Velikova, Galina

AU - Åsenlöf, Pernilla

AU - Nordin, Karin

PY - 2017/3/27

Y1 - 2017/3/27

N2 - 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 × 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.DISCUSSION: The 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.

AB - 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 × 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.DISCUSSION: The 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.

KW - Breast Neoplasms/epidemiology

KW - Cancer Survivors

KW - Colorectal Neoplasms/epidemiology

KW - Exercise Therapy

KW - Fatigue/pathology

KW - Female

KW - Humans

KW - Male

KW - Physical Fitness/physiology

KW - Prostatic Neoplasms/epidemiology

KW - Quality of Life

U2 - 10.1186/s12885-017-3197-5

DO - 10.1186/s12885-017-3197-5

M3 - Article

VL - 17

SP - 218

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

IS - 1

ER -