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Oncology
Protocol
Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors
  1. Adele Krusche1,
  2. Katherine Bradbury1,
  3. Teresa Corbett2,
  4. Jane Barnett3,
  5. Beth Stuart3,
  6. Guiqing Lily Yao4,
  7. Roger Bacon5,
  8. Dankmar Böhning6,
  9. Tara Cheetham-Blake2,
  10. Diana Eccles7,
  11. Claire Foster8,
  12. Adam William Alfred Geraghty3,
  13. Geraldine Leydon3,
  14. Andre Müller9,
  15. Richard D Neal10,
  16. Richard Osborne11,
  17. Shanaya Rathod12,
  18. Alison Richardson2,
  19. Geoffrey Sharman5,
  20. Kevin Summers5,
  21. Eila Watson13,
  22. Laura Wilde14,
  23. Clare Wilkinson15,
  24. Lucy Yardley1,16,
  25. Paul Little3
  1. 1 Department of Psychology, University of Southampton, Southampton, UK
  2. 2 School of Health Sciences, University of Southampton, Southampton, UK
  3. 3 Primary Care and Population Sciences Division, University of Southampton, Southampton, UK
  4. 4 Biostatistics Research Group, University of Leicester, Leicester, UK
  5. 5 Patient and Public Involvement team for the CLASP project
  6. 6 Mathematical Sciences, University of Southampton, Southampton, UK
  7. 7 Southampton Clinical Trials Unit, University of Southampton, Southampton, UK
  8. 8 Macmillan Survivorship Research Group, University of Southampton, Southampton, UK
  9. 9 Saw Swee Hock Public School of Health, National University of Singapore, Singapore
  10. 10 Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
  11. 11 Dorset Cancer Centre, Poole, UK
  12. 12 Southern Health NHS Foundation Trust, Southampton, UK
  13. 13 School of Nursing and Midwifery, Oxford Brookes University, Oxford, UK
  14. 14 Faculty of Health & Life Sciences, Coventry University, Coventry, UK
  15. 15 School of Health Sciences, Bangor University, Bangor, UK
  16. 16 School of Experimental Psychology, University of Bristol, Bristol, UK
  1. Correspondence to Dr Adele Krusche; a.s.krusche{at}soton.ac.uk

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.

  • ehealth
  • psycho-oncology
  • digital interventions
  • cancer
  • quality of life
  • survivorship

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/.

https://doi.org/10.1136/bmjopen-2018-024862

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    Footnotes

    • Contributors AK drafted the manuscript with input from all authors. LY and PL designed the study and secured funding. LY and KB led the overall development of Renewed online. LY, AK, KB, JB, and TeC developed procedures for the study design with help from LW. LY and KB oversaw the development of all of the intervention and had final approval of all content. AK and AWAG developed resources for Healthy Paths. AM, KS and TeC developed resources for Getting Active. TaC-B developed additional content for men on Active Surveillance. All co-authors and PPI reps (RB, GL, GS, KS) also provided input into the development of Renewed. BS wrote the statistical analysis plan. GLY wrote the plan for the health economic analysis. DB, DE, CF, RDN, RO, SR, AR, EW and CW contributed to the study design as part of the management team and contributed to the final version of the manuscript. All authors approved the final manuscript. AK is the guarantor.

    • Funding This project is funded by the National Institute for Health Research (NIHR) [Programme Grants for Applied Research Programme/Reference Number RP-PG-0514-20001]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care (See page 39).

    • Competing interests None declared.

    • Ethics approval This trial was approved in March 2017 by Ethics and Research Governance in Southampton, ID 25160 and has been approved by the NHS Research Ethics Committee via the Integrated Research Application System, ID 238636, N/RES Reference 18/NW/0013.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.