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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

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
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.

adult oncology, oncology, public health, rehabilitation medicine
2044-6055
e048175
Grimmett, Chloe
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Bates, Andrew
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West, Malcolm
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Leggett, Samantha
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Varkonyi-Sepp, Judit
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Campbell, Anna
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Davis, June
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Wootton, Stephen
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Shaw, Clare
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Barlow, Rachael
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Ashcroft, Joanna
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Scott, Andrew
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Moyes, Helen
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Hawkins, Lesley
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Levett, Denny Z H
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Williams, Fran
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Grocott, Michael P W
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Jack, Sandy
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Grimmett, Chloe
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Bates, Andrew
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West, Malcolm
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Leggett, Samantha
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Varkonyi-Sepp, Judit
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Campbell, Anna
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Davis, June
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Wootton, Stephen
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Shaw, Clare
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Barlow, Rachael
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Ashcroft, Joanna
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Scott, Andrew
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Moyes, Helen
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Hawkins, Lesley
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Levett, Denny Z H
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Williams, Fran
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Grocott, Michael P W
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Jack, Sandy
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Grimmett, Chloe, Bates, Andrew, West, Malcolm, Leggett, Samantha, Varkonyi-Sepp, Judit, Campbell, Anna, Davis, June, Wootton, Stephen, Shaw, Clare, Barlow, Rachael, Ashcroft, Joanna, Scott, Andrew, Moyes, Helen, Hawkins, Lesley, Levett, Denny Z H, Williams, Fran, Grocott, Michael P W and Jack, Sandy (2021) 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. BMJ Open, 11 (8), e048175, [e048175]. (doi:10.1136/bmjopen-2020-048175).

Record type: Article

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.

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Accepted/In Press date: 23 July 2021
Published date: 26 August 2021
Additional Information: Funding Information: Contributors CG drafted the manuscript. CG, SJ, JD and MPWG made substantial contributions to the conception and design of the trial. JA provided clinical psychology expertise, contributing to the design of the psychological component of the intervention and providing critical intellectual content. SW, CS and RB provided nutrition and dietetic expertise, contributing to the design of the nutritional components of the intervention and providing critical intellectual content. JV-S provided expertise in Healthy Conversation Skills Training, contributing to the design of the behaviour change components of the intervention and providing critical intellectual content. AS and AC provided expertise in exercise oncology and methods of evaluation, contributing to the design of the exercise components of the intervention and providing critical intellectual content. DZHL provided clinical oversight and expertise. SL, LH, FW, MW and AB provided expertise in trial process and management. HM provided statistical expertise and devised the analysis plan with CG, SJ and MPWG. All authors contributed critically to the revision and final approval of the manuscript. Funding Funding has been received from Macmillan Cancer Support (award/ grant number is not applicable), the Wessex Cancer Alliance (award/grant number is not applicable), the National Lottery (Digital, Culture Media and Sport grant number 20142065) and the Clinical Research Network (award/grant number is not applicable) to support this trial. This protocol includes independent work (CS) supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London. MG is partly funded by the NIHR Senior Investigator Scheme and the NIHR Southampton Biomedical Research Centre. SL is supported by the National Institute for Health Research through the NIHR Southampton Biomedical Research. Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Competing interests None declared. Publisher Copyright: © 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. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: adult oncology, oncology, public health, rehabilitation medicine

Identifiers

Local EPrints ID: 451201
URI: http://eprints.soton.ac.uk/id/eprint/451201
ISSN: 2044-6055
PURE UUID: 4520271e-4bb1-4085-9bb0-32fa5f2a856a
ORCID for Chloe Grimmett: ORCID iD orcid.org/0000-0002-7540-7206
ORCID for Andrew Bates: ORCID iD orcid.org/0000-0002-3614-0270
ORCID for Malcolm West: ORCID iD orcid.org/0000-0002-0345-5356
ORCID for Michael P W Grocott: ORCID iD orcid.org/0000-0002-9484-7581

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Date deposited: 14 Sep 2021 16:35
Last modified: 17 Mar 2024 04:12

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Contributors

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

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