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

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

Individual Support for Cancer Patients : Effects, Patient Satisfaction and Utilisation

The aims of this thesis are threefold: (1) To investigate cancer patients’ satisfaction with and utilisation of an Individual Psychological Support (IPS) intervention. (2) To evaluate the effects of Individual Support (IS), comprising IPS combined with Intensified Primary Health Care and Nutritional Support, on psychological distress and quality of life during the first year after diagnosis. (3) To explore to what extent aspects of quality of life and emotional functioning one year after diagnosis can be predicted by medical, psychological and socio-demographic factors at diagnosis. The analyses are based on data from the Support-Care-Rehabilitation project, using a prospective randomised design to compare four conditions: (1) Individual Support (IS) starting at diagnosis, (2) Group Rehabilitation (GR) starting three months later, (3) a combination of IS and GR, and (4) Standard Care (SC). The study sample consisted of patients newly diagnosed with breast cancer, colorectal cancer, gastric cancer or prostate cancer. A total of 481 patients were randomised and followed for 24 months. The IPS was an individually tailored, problem-focused intervention based on psychosocial oncology and cognitive behaviour therapy. Half of the patients receiving IPS had more than 2 sessions. Patients reporting that they had problems to address received more IPS sessions and reported more benefits of the intervention. Receiving an extensive medical treatment, young age, and not having someone besides the family to rely on in times of difficulties increased the odds of receiving tree or more sessions of IPS. The IS had limited impact on psychological distress and quality of life in intention-to-treat analyses. Additional analyses with stratification for baseline anxiety and/or depression levels suggested that for IS patients with higher levels of anxiety and/or depression, these problems continued to diminish below those of Control patients during the first year after diagnosis. Linear regression models were used to explore, one year after diagnosis, quality of life aspects indicative of rehabilitation needs. High levels of baseline anxiety and / or depressive symptoms were associated with lower levels of Emotional Functioning, and high self-rated well-being was associated with higher levels of Emotional Functioning. Extensive medical treatment and presence of comorbid conditions during the year before diagnosis predicted a low Global Quality of Life, whereas self-rated wellbeing predicted a high Global Quality of Life. Advanced disease, one or more comorbid conditions and high age were found to be associated with lower levels of Physical Functioning. A high level of activities outside the home during the year before diagnosis and high self-rated wellbeing were predictive of a better Physical Functioning. In conclusion, a large proportion of cancer patients offered IPS in conjunction with diagnosis and primary treatments seized this opportunity to discuss their situation, and perceived the experience as beneficial. Thus, offering newly diagnosed cancer patients these psychosocial support services may facilitate their situation

Individual Support for Cancer Patients : Effects, Patient Satisfaction and Utilisation

The aims of this thesis are threefold: (1) To investigate cancer patients’ satisfaction with and utilisation of an Individual Psychological Support (IPS) intervention. (2) To evaluate the effects of Individual Support (IS), comprising IPS combined with Intensified Primary Health Care and Nutritional Support, on psychological distress and quality of life during the first year after diagnosis. (3) To explore to what extent aspects of quality of life and emotional functioning one year after diagnosis can be predicted by medical, psychological and socio-demographic factors at diagnosis. The analyses are based on data from the Support-Care-Rehabilitation project, using a prospective randomised design to compare four conditions: (1) Individual Support (IS) starting at diagnosis, (2) Group Rehabilitation (GR) starting three months later, (3) a combination of IS and GR, and (4) Standard Care (SC). The study sample consisted of patients newly diagnosed with breast cancer, colorectal cancer, gastric cancer or prostate cancer. A total of 481 patients were randomised and followed for 24 months. The IPS was an individually tailored, problem-focused intervention based on psychosocial oncology and cognitive behaviour therapy. Half of the patients receiving IPS had more than 2 sessions. Patients reporting that they had problems to address received more IPS sessions and reported more benefits of the intervention. Receiving an extensive medical treatment, young age, and not having someone besides the family to rely on in times of difficulties increased the odds of receiving tree or more sessions of IPS. The IS had limited impact on psychological distress and quality of life in intention-to-treat analyses. Additional analyses with stratification for baseline anxiety and/or depression levels suggested that for IS patients with higher levels of anxiety and/or depression, these problems continued to diminish below those of Control patients during the first year after diagnosis. Linear regression models were used to explore, one year after diagnosis, quality of life aspects indicative of rehabilitation needs. High levels of baseline anxiety and / or depressive symptoms were associated with lower levels of Emotional Functioning, and high self-rated well-being was associated with higher levels of Emotional Functioning. Extensive medical treatment and presence of comorbid conditions during the year before diagnosis predicted a low Global Quality of Life, whereas self-rated wellbeing predicted a high Global Quality of Life. Advanced disease, one or more comorbid conditions and high age were found to be associated with lower levels of Physical Functioning. A high level of activities outside the home during the year before diagnosis and high self-rated wellbeing were predictive of a better Physical Functioning. In conclusion, a large proportion of cancer patients offered IPS in conjunction with diagnosis and primary treatments seized this opportunity to discuss their situation, and perceived the experience as beneficial. Thus, offering newly diagnosed cancer patients these psychosocial support services may facilitate their situation

Prediction of post-operative pain after a laparoscopic tubal ligation procedure.

Background: Pre-operative identification of reliable predictors of post-operative pain may lead to improved pain management strategies. We investigated the correlation between pre-operative pain, psychometric variables, response to heat stimuli and post-operative pain following a laparoscopic tubal ligation procedure. Methods: Assessments of anxiety, mood, psychological vulnerability and pre-operative pain were made before surgery using the State-Trait Anxiety Inventory (STAI), the Hospital Anxiety Depression Scale (HADS), a psychological vulnerability test and the Short-Form McGill Pain Questionnaire (SF-MPQ), respectively. Pre-operative assessments of thermal thresholds and pain response to randomized series of heat stimuli (1 s, 44-48 degrees C) were made with quantitative sensory testing technique. Post-operative pain intensity was evaluated daily by a visual analogue scale during rest and during standardized dynamic conditions for 10 days following surgery. Univariate and multivariate regression analyses were used to construct prediction models. Results: Fifty-nine patients completed the study. Post-operative pain was significantly correlated with pre-operative pain (SF-MPQ), heat pain perception, psychological vulnerability, STAI and HADS. In the multiple regression model pre-operative pain and heat pain perception were significant predictive factors (R=0.537-0.609). Conclusion: The study indicates that pre-surgical pain and heat pain sensitivity are important pre-operative indicators of post-operative pain intensity, while psychological factors like vulnerability and anxiety seem to contribute to a lesser degree after laparoscopic tubal ligation. The prediction model accounted for 29-43% of the total variance in post-operative movement-related pain

Validation of the Distress Thermometer in a Swedish population of oncology patients; accuracy of changes during six months

Purpose: To validate the Swedish version of the Distress Thermometer (DT) against the Hospital Anxiety and Depression Scale (HADS) for screening of distress and to explore how well DT measures changes of distress during six months in a population of heterogeneous oncology patients. Methods: The DT was translated into Swedish according to the forward- and back-translation procedure. HADS total score >= 15 was used as gold standard. Consecutive patients were invited to participate at their first visit to the Oncology department. The HADS and the DT were completed at baseline and after I, 3 and 6 months. Results: 462 baseline and 321 six-month assessments were completed. The patients had a variety of cancer diagnoses (n = 42). Most patients (95%) received active treatment. The DT compared favourably with the HADS. The area under the curve was 0.86 (95% CI, 0.82-0.90). DT >= 4 showed a sensitivity of 87%, a specificity of 73%, a positive predictive value (PPV) of 52% and a negative predictive value (NPV) of 95% at baseline. The results from the 1, 3 and 6 months assessments were equivalent baseline results. The DT means changed in the same direction as HADS at all points of assessment. Patients with distress reported statistically significantly more problems in all categories on the associated 'Problem List' compared to non-distressed patients. Conclusion: The Swedish version of the DT with a score >= 4 is valid for screening of distress in heterogeneous oncology patients. Its ability to measure changes in distress over time is comparable to HADS. (c) 2012 Elsevier Ltd. All rights reserved

Cancer rehabilitation: A Nordic and European perspective

To access publisher full text version of this article. Please click on the hyperlink in Additional Links fieldBACKGROUND: The increasing incidence of cancer combined with prolonged survival times seen throughout the western world increases the need for rehabilitation. Diagnosis and treatment for cancer may have substantial effects on the patients' physical, psychological, social and existential well-being. The aim of this paper is to describe the current situation in cancer rehabilitation in the Nordic countries, the Netherlands and Germany. MATERIAL AND METHODS: Description of the current situation in cancer rehabilitation in the Nordic countries and literature review. RESULTS: Rehabilitation as defined by multiple organizations covers a multidimensional view on chronic disease and its effect on the patient's life. The rehabilitation systems in Denmark, Finland, Sweden, Germany and the Netherlands differ depending on the differing social security and health-care systems, but rehabilitation provided is largely based on a similar, multidimensional and multidisciplinary understanding of cancer rehabilitation. Research on rehabilitation efforts in European countries indicates that there is substantial evidence with regard to single interventions which can be part of cancer rehabilitation. DISCUSSION: In order to assure patients and families continuing quality of life, rehabilitation should be an integral and continuous part of all cancer car

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial

Exercise during cancer treatment improves cancer-related fatigue (CRF), but the importance of exercise intensity for CRF is unclear. We compared the effects of high- vs low-to-moderate-intensity exercise with or without additional behavior change support (BCS) on CRF in patients undergoing (neo-)adjuvant cancer treatment. This was a multicenter, 2x2 factorial design randomized controlled trial (Clinical Trials NCT02473003) in Sweden. Participants recently diagnosed with breast (n = 457), prostate (n = 97) or colorectal (n = 23) cancer undergoing (neo-)adjuvant treatment were randomized to high intensity (n = 144), low-to-moderate intensity (n = 144), high intensity with BCS (n = 144) or low-to-moderate intensity with BCS (n = 145). The 6-month exercise intervention included supervised resistance training and home-based endurance training. CRF was assessed by Multidimensional Fatigue Inventory (MFI, five subscales score range 4-20), and Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F, score range 0-52). Multiple linear regression for main factorial effects was performed according to intention-to-treat, with post-intervention CRF as primary endpoint. Overall, 577 participants (mean age 58.7 years) were randomized. Participants randomized to high- vs low-to-moderate-intensity exercise had lower physical fatigue (MFI Physical Fatigue subscale; mean difference −1.05 [95% CI: −1.85, −0.25]), but the difference was not clinically important (ie <2). We found no differences in other CRF dimensions and no effect of additional BCS. There were few minor adverse events. For CRF, patients undergoing (neo-)adjuvant treatment for breast, prostate or colorectal cancer can safely exercise at high- or low-to-moderate intensity, according to their own preferences. Additional BCS does not provide extra benefit for CRF in supervised, well-controlled exercise interventions