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

doi:10.1136/bmjopen-2020-048175

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

University of Portsmouth Ageing Network

Research output: Contribution to journal › Article › peer-review

71 Downloads (Pure)

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.

Original language	English
Article number	e048175
Number of pages	8
Journal	BMJ Open
Volume	11
Issue number	8
DOIs	https://doi.org/10.1136/bmjopen-2020-048175
Publication status	Published - 26 Aug 2021

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1136/bmjopen-2020-048175

SafeFit TrialFinal published version, 408 KBLicence: CC BY-NC

SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer
Scott, A.
4/05/20 → 26/01/24
Project: Research
MSc Clinical Exercise Science
Scott, A.
18/09/17 → 25/09/20
Project: Innovation

Cite this

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., Moyes, H., Hawkins, L., Levett, D. Z. H., Williams, F., Grocott, M. P. W., & Jack, S. (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), Article e048175. https://doi.org/10.1136/bmjopen-2020-048175

@article{615a375393cf4640aaa169f39841d128,

title = "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",

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.",

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

year = "2021",

month = aug,

day = "26",

doi = "10.1136/bmjopen-2020-048175",

language = "English",

volume = "11",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "8",

}

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, Moyes, H, Hawkins, L, Levett, DZH, Williams, F, Grocott, MPW & Jack, S 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, vol. 11, no. 8, e048175. https://doi.org/10.1136/bmjopen-2020-048175

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. / Grimmett, Chloe; Bates, Andrew; West, Malcolm et al.
In: BMJ Open, Vol. 11, No. 8, e048175, 26.08.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Grimmett, Chloe

AU - Bates, Andrew

AU - West, Malcolm

AU - Leggett, Samantha

AU - Varkonyi-Sepp, Judit

AU - Campbell, Anna

AU - Davis, June

AU - Wootton, Stephen

AU - Shaw, Clare

AU - Barlow, Rachael

AU - Ashcroft, Joanna

AU - Scott, Andrew

AU - Moyes, Helen

AU - Hawkins, Lesley

AU - Levett, Denny Z H

AU - Williams, Fran

AU - Grocott, Michael P W

AU - Jack, Sandy

PY - 2021/8/26

Y1 - 2021/8/26

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2020-048175

DO - 10.1136/bmjopen-2020-048175

M3 - Article

SN - 2044-6055

VL - 11

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e048175

ER -

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

Abstract

UN SDGs

Access to Document

Fingerprint

Projects

SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer

MSc Clinical Exercise Science

Cite this