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

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

Local EPrints ID: 451201

URI: http://eprints.soton.ac.uk/id/eprint/451201

DOI: doi:10.1136/bmjopen-2020-048175

ISSN: 2044-6055

PURE UUID: 4520271e-4bb1-4085-9bb0-32fa5f2a856a

ORCID for Chloe Grimmett: orcid.org/0000-0002-7540-7206

ORCID for Andrew Bates: orcid.org/0000-0002-3614-0270

ORCID for Malcolm West: orcid.org/0000-0002-0345-5356

ORCID for Michael P W Grocott: orcid.org/0000-0002-9484-7581

Date deposited: 14 Sep 2021 16:35

Last modified: 12 Nov 2024 03:09