Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

Adele Krusche; Katherine Bradbury; Teresa  Corbett; Jane Barnett; Beth Stuart; Guiqing Lily  Yao; Roger Bacon; Dankmar  Böhning; Tara  Cheetham-Blake; Diana Eccles; Claire Foster; Adam William Alfred Geraghty; Geraldine  Leydon; Andre Müller; Richard D Neal; Richard  Osborne; Shanaya  Rathod; Alison Richardson; Geoffrey  Sharman; Kevin Summers; Eila Watson; Laura Joanne Wilde; Clare  Wilkinson; Lucy Yardley; Paul Little

doi:10.1136/bmjopen-2018-024862

Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

Adele Krusche, Katherine Bradbury, Teresa Corbett, Jane Barnett, Beth Stuart, Guiqing Lily Yao, Roger Bacon, Dankmar Böhning, Tara Cheetham-Blake, Diana Eccles, Claire Foster, Adam William Alfred Geraghty, Geraldine Leydon, Andre Müller, Richard D Neal, Richard Osborne, Shanaya Rathod, Alison Richardson, Geoffrey Sharman, Kevin SummersEila Watson , Laura Joanne Wilde, Clare Wilkinson, Lucy Yardley, Paul Little

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Abstract

Introduction Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.

Methods and analysis A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.

Ethics and dissemination The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.

Trial registration number ISRCTN96374224; Pre-results.

Original language	English
Article number	e024862
Number of pages	11
Journal	BMJ Open
Volume	2019
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2018-024862
Publication status	Published - 1 Mar 2019

Bibliographical note

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

UN SDGs

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

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Renewed pdfFinal published version, 1.06 MBLicence: CC BY

Cite this

Krusche, A., Bradbury, K., Corbett, T., Barnett, J., Stuart, B., Yao, G. L., Bacon, R., Böhning, D., Cheetham-Blake, T., Eccles, D., Foster, C., Geraghty, A. W. A., Leydon, G., Müller, A., Neal, R. D., Osborne, R., Rathod, S., Richardson, A., Sharman, G., ... Little, P. (2019). Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors. BMJ Open, 2019(9), Article e024862. https://doi.org/10.1136/bmjopen-2018-024862

Krusche, A, Bradbury, K, Corbett, T, Barnett, J, Stuart, B, Yao, GL, Bacon, R, Böhning, D, Cheetham-Blake, T, Eccles, D, Foster, C, Geraghty, AWA, Leydon, G, Müller, A, Neal, RD, Osborne, R, Rathod, S, Richardson, A, Sharman, G, Summers, K, Watson , E, Wilde, LJ, Wilkinson, C, Yardley, L & Little, P 2019, 'Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors', BMJ Open, vol. 2019, no. 9, e024862. https://doi.org/10.1136/bmjopen-2018-024862

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abstract = "Introduction Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysis A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and dissemination The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration number ISRCTN96374224; Pre-results.",

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AU - Krusche, Adele

AU - Bradbury, Katherine

AU - Corbett, Teresa

AU - Barnett, Jane

AU - Stuart, Beth

AU - Yao, Guiqing Lily

AU - Bacon, Roger

AU - Böhning, Dankmar

AU - Cheetham-Blake, Tara

AU - Eccles, Diana

AU - Foster, Claire

AU - Geraghty, Adam William Alfred

AU - Leydon, Geraldine

AU - Müller, Andre

AU - Neal, Richard D

AU - Osborne, Richard

AU - Rathod, Shanaya

AU - Richardson, Alison

AU - Sharman, Geoffrey

AU - Summers, Kevin

AU - Watson , Eila

AU - Wilde, Laura Joanne

AU - Wilkinson, Clare

AU - Yardley, Lucy

AU - Little, Paul

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PY - 2019/3/1

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N2 - Introduction Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysis A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and dissemination The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration number ISRCTN96374224; Pre-results.

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U2 - 10.1136/bmjopen-2018-024862

DO - 10.1136/bmjopen-2018-024862

M3 - Article

SN - 2044-6055

VL - 2019

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e024862

ER -

Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

Abstract

Bibliographical note

UN SDGs

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