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.

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. TRIAL REGISTRATION: NCT02473003 , October, 2014.

Cancer rehabilitation: A Nordic and European perspective.

BACKGROUND: 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 care.

[Early and individualized cancer rehabilitation important]. / Tidig och individualiserad cancerrehabilitering viktig.

Survivors of gynecological cancer experience physical, psychological and existential consequences. Late gastrointestinal and urinary bladder symptoms, sexual dysfunction, including underlying physical and relational aspects, as well as lymphedema and fatigue, are common complaints. This may lead to reduced quality of life and social functioning and cancer rehabilitation is needed. Cancer rehabilitation, focusing on the individual cancer survivor and her specific needs, starting at diagnosis and continuing throughout cancer treatment and at follow-ups, is necessary.

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 1, 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.

Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care.

In a prospective, randomized study, an individual psychosocial support intervention performed by specially trained oncology nurses, or psychologists, were compared with standard care. Consecutive primary breast cancer patients about to start adjuvant therapy (n = 179) were included. Data were supplied by the questionnaires European Organisation for Research and Treatment of Cancer Quality of Life Study Group Core Quality of life questionnaire with 30 questions (EORTC QLQ-C30) and Breast Cancer Module with 23 questions (BR23), the Hospital Anxiety and Depression Scale, Spielberger's State-Trait Anxiety Inventory, and the Impact of Event Scale before randomization and 1, 3, and 6 months later. Patient files provided data on utilization of psychosocial support offered in routine care. Global quality of life/health status, nausea and vomiting, and systemic therapy side effects were the subscales showing significant Group by Time interactions, favoring the interventions. Intervention groups improved statistically significantly more than the standard care group regarding insomnia, dyspnea, and financial difficulties. Nurse patients experienced less intrusion compared with the standard care group. All groups showed statistically and clinically significant improvements with time on several subscales. The intervention groups, however, improved to a greater extent. Fewer patients in the intervention groups used psychosocial hospital support compared with the standard care group. In conclusion, psychosocial support by specially trained nurses using techniques derived from cognitive behavioral therapy is beneficial for breast cancer patients and may be a realistic alternative in routine cancer care.