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

Chloe Grimmett, Andrew Bates, Malcolm West, Samantha Leggett, Judit Varkonyi-Sepp, Anna Campbell, June Davis, Stephen Wootton, Clare Shaw, Rachael Barlow, Joanna Ashcroft, Andrew Scott, Helen Moyes, Lesley Hawkins, Denny Z H Levett, Fran Williams, Michael P W Grocott, Sandy Jack, Chloe Grimmett, Andrew Bates, Malcolm West, Samantha Leggett, Judit Varkonyi-Sepp, Anna Campbell, June Davis, Stephen Wootton, Clare Shaw, Rachael Barlow, Joanna Ashcroft, Andrew Scott, Helen Moyes, Lesley Hawkins, Denny Z H Levett, Fran Williams, Michael P W Grocott, Sandy Jack

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 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.

Keywords: adult oncology; oncology; public health; rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial flow.

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