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

Grimmett, C.; Bates, A.; West, M.; Leggett, S.; Varkonyi-Sepp, J.; Campbell, A.; Davis, J.; Wootton, S.; Shaw, C.; Barlow, R.; Ashcroft, J.; Scott, A.; Moyses, H.; Hawkins, L.; Levett, D.Z.H.; Williams, F.; Grocott, M.P.W.; Jack, S.

Abstract

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 multi-modal intervention of physical activity, nutrition and psychological support delivered virtually by cancer exercise specialists (CES) can improve physical and emotional functioning 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 six 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 a behaviour change intervention.

Primary outcome: Physical and emotional functioning as measured by the 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: NCT04425616

Citation

Grimmett, C., Bates, A., West, M., Leggett, S., Varkonyi-Sepp, J., Campbell, A., …Jack, S. (2021). SafeFit Trial: Virtual clinics to deliver a multimodal intervention to improve psychological and physical wellbeing in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open, 11(8), Article e048175. https://doi.org/10.1136/bmjopen-2020-048175

• Journal Article Type: Article
• Acceptance Date: Jun 23, 2021
• Online Publication Date: Aug 26, 2021
• Publication Date: 2021
• Deposit Date: Aug 25, 2021
• Publicly Available Date: Aug 26, 2021
• Journal: BMJ Open
• Print ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 11
• Issue: 8
• Article Number: e048175
• DOI: https://doi.org/10.1136/bmjopen-2020-048175
• Keywords: cancer, intervention, physical activity, nutrition, psychological support, multimodal, virtual
• Public URL: http://researchrepository.napier.ac.uk/Output/2796116