SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial.

INTRODUCTION: The impact of the COVID-19 pandemic (caused by the SARS-CoV-2 virus) on individuals with cancer has been profound. It has led to increased anxiety, distress and deconditioning due to reduced physical activity. We aim to investigate whether SafeFit, a multimodal intervention of physical activity, nutrition and psychological support delivered virtually by cancer exercise specialists (CES), can improve physical and emotional functionings during the COVID-19 pandemic. METHODS AND ANALYSIS: A phase III non-randomised intervention trial, target recruitment of 1050 adults with suspected or confirmed diagnosis of cancer. All recruited participants will receive the multimodal intervention delivered by CES for 6 months. Sessions will be delivered 1-to-1 using telephone/video conferencing consultations. CES will work with each participant to devise a personalised programme of (1) physical activity, (2) basic dietary advice and (3) psychological support, all underpinned by behaviour change support. PRIMARY OUTCOME: Physical and emotional functioning as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30). SECONDARY OUTCOMES: overall quality of life measured by EORTC-QLQ-C30 and EQ-5D-5L, health economics, patient activation, self-efficacy to self-manage chronic disease, distress, impact of COVID-19 on emotional functioning, self-reported physical activity, functional capacity and nutrition. Adherence to the intervention will also be measured and a process evaluation conducted. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Health Research Authority (reference number 20/NW/0254). Results of this trial will be disseminated through publication of peer-reviewed articles, presentations at scientific conferences, and to the public and people with cancer in collaboration with our patient and public involvement representatives and partners. TRIAL REGISTRATION NUMBER: NCT04425616.

Emotional suppression in chronic fatigue syndrome: Experimental study.

OBJECTIVE: Emotional processing differences in chronic fatigue syndrome (CFS) have been reported but have rarely been investigated experimentally. This study used self-report, observer ratings, and electrodermal responses to test hypotheses about emotion suppression and autonomic reactivity. METHODS: Eighty adults with CFS and 80 healthy controls (HC) watched a distressing film clip. Half of each group were instructed to suppress their emotions and half were told to express their feelings as they wished. Their reactions were filmed and rated by independent observers. Electrodermal activity (skin conductance response) was used as a measure of sympathetic nervous system arousal. RESULTS: CFS participants reported higher anxiety and sadness than the HC, both before and after the film. However, observers rated the CFS group as having lower emotional expression than HC in both emotional suppression and expression choice conditions. Beliefs about the unacceptability of negative emotions were associated with greater self-reported suppression. Electrodermal responses were greater in the CFS group than HC participants. Higher skin conductance responses were associated with larger posttask increases in fatigue in the CFS participants but not in the HC. CONCLUSIONS: CFS participants had lower observer-rated emotional expression than HC, despite greater distress and higher autonomic arousal. This may have implications for their ability to access social support at times of stress. As the degree of autonomic arousal was associated with short-term increases in fatigue in the CFS participants, this requires further investigation as a contributory factor for this condition. (PsycINFO Database Record