Scientific abstract
Background
Cancer causes 20% of deaths in the European region and more than 3 million new cases are reported each year. In addition, due to early detection and advances in treatment, the number of survivors is increasing. Cancer related fatigue (CRF), which is the main outcome in the present project, is reported in up to 90% of cancer patients during adjuvant oncological treatment. CRF is a multidimensional concept comprised of physical, social, emotional, psychological and biological components experienced by persons treated for cancer.
Thus, CRF has a serious impact on the patient’s quality of life and causes a considerable challenge to society in human and economic terms. Alteration in cytokines secreted from contracting muscle, loss of physical capacity, as well as immune and cytokine dysregulation have been suggested as playing a developmental and maintaining role in CRF. Few studies have investigated the effects of physical training on genetic biomarkers and systemic inflammatory markers in cancer patients and few have been designed to address any associations to CRF. Systematic reviews underline an important potential for physical and psychosocial benefits of clinical significance from rehabilitation programs including physical training.
Furthermore, the importance and challenges of integrating lifestyle support during therapy and during the rehabilitation process and to facilitate implementation in clinical practice are underlined. Courneya et al points out in a recent publication the top 10 research questions related to physical training and cancer survivorship and many of them are covered in the present application eg to further investigate the optimal exercise prescription (eg intensity), if exercise reduces the risk for cancer recurrence and influences treatment completion rates, the role of behavior change techniques and variables that may modify/mediate the responses to exercise.
Hypothesis and objectives
The main aim is to determine the effects of high or low/medium intensity physical training with or without integrated behavioural medicine support strategies to prevent and minimize cancer related fatigue (CRF), improve health related quality of life, disease outcome and to understand the role of inflammation, cytokines and gene expression in the development and maintenance of CRF, as well as to increase knowledge with respect to cost-effectiveness of rehabilitation programs. This will be evaluated in 600 newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different University hospitals in Sweden.
Settings and methods
Patients will be randomized to one of the following four groups:
A) individually tailored high intensity training with (H+BM) or without behavioural medicine support strategies (H), or
B) individually tailored low-moderate intensity training with (LM+BM) or without behavioural medicine support strategies (LM).
A 2×2 factorial design will be used. With this design we can study main effects and interactions between factors (groups). All patients will exercise during six months. The resistance training will take place in supervised sessions and will be performed at a fixed per cent of maximal muscular strength. The cardiovascular endurance training will be performed at home. Training intensity is 40-50% (LM) or 80-90% (H) of maximal cardiorespiratory fitness/muscular strength.
Impact
We aim to disseminate our results to a broad audience, including the international scientific community, patient organizations and the general public. Also implement our results into clinical practice through close collaboration between researchers, clinicians and patients.
Clinical impact for the individual patient as well as on public health will be an improved well-being and quality-of-life for a large number of cancer patients and a consequence may be reduced societal costs because patients´ return to work may be facilitated. There may be lower health care costs and a lower burden on the health care system because it is expected that treatment regimens based on physical training and behavioural medicine support will lower the need for symptom directed pharmaceutical intervention.
The new tailored behavioural medicine strategies will help cancer survivors to maintain a healthy lifestyle to prevent common future morbidity conditions such as cardiovascular diseases, osteoporosis and diabetes.
Plain language abstract
Background
Cancer is a common disease and 3 million new cases are reported each year in the European region. Cancer related fatigue (CRF) is a prevalent problem in cancer patients affecting their daily activities and quality of life. There is limited knowledge about what causes CRF and there is no medical treatment.
Several studies have revealed that physical training can decrease CRF but more knowledge is needed about the optimal dose and mode of training. As the cancer disease and its treatment may introduce significant challenges to perform physical traning, we need to develop structured methods providing motivational and behavioural support. In addition, to be able to better help patients to manage their fatigue, it is important to learn more about the underlying biological mechanism of fatigue.
Aims and objectives
The main aim is to determine the effects of physical training of different intensity in combination with, or without, motivational and behavioural support strategies during adjuvant cancer therapy. The effects will be measured in the patients reported cancer related fatigue (CRF), health related quality of life and disease outcome. We also aim to study the underlying biological mechanism in the development and maintenance of CRF, as well as the cost-effectiveness of the intervention. This will be evaluated in 600 newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different University hospitals in Sweden.
How it will be done
Patients will be randomized to one of four of the following conditions (all including strength- and endurance training):
- Physical training with low-moderate intensity
- Physical training with high intensity
- Physical training with low-moderate intensity with behavioural support
- Physical training with high intensity with behavioural support
Behavioural support includes extra motivational coaching. All patients will train during six months.The resistance training will take place in supervised sessions and will be performed at a fixed per cent of maximal muscular strength. The cardiovascular endurance training will be performed at home. Training intensity during low-moderate intensity is 40-50% and 80-90% of maximal cardiorespiratory fitness/muscular strength during high intensity.
Potential impact
The impact for the individual patient as well as on public health is expected to be improved well-being and quality-of-life for a large number of cancer patients. There may be lower health care costs and a lower burden on the health care system because it is expected that treatment regimens based on physical training and motivational support may lower the need for symptom directed pharmaceutical intervention. Physical training will also help cancer survivors to maintain a healthy lifestyle to prevent common future morbidity conditions such as cardiovascular diseases, osteoporosis and diabetes.