Article Text

PDF

Improving the well-being of men by Evaluating and Addressing the Gastrointestinal Late Effects (EAGLE) of radical treatment for prostate cancer: study protocol for a mixed-method implementation project
  1. Sophia Taylor1,
  2. Weyinmi Demeyin2,
  3. Ann Muls3,
  4. Catherine Ferguson4,
  5. Damian J J Farnell5,
  6. David Cohen6,
  7. Jervoise Andreyev3,
  8. John Green7,
  9. Lesley Smith8,
  10. Sam Ahmedzai9,
  11. Sara Pickett10,
  12. Annmarie Nelson1,
  13. John Staffurth11,12
  1. 1Marie Curie Palliative Care Research Centre, School of Medicine, Cardiff University, Cardiff, UK
  2. 2Specialist Unit for Review Evidence, Cardiff University, Cardiff, UK
  3. 3Gastroenterology Unit, Royal Marsden Hospital, London, UK
  4. 4Department of Oncology, Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  5. 5School of Dentistry, Cardiff University, Cardiff, UK
  6. 6Faculty of Life Sciences and Education, Health Economics and Policy Research Unit (HEPRU), University of South Wales, Cardiff, UK
  7. 7Department of Gastroenterology, University Hospital of Llandough, Cardiff, UK
  8. 8Macmillan Cancer Support, London, UK
  9. 9Department of Oncology, University of Sheffield, Sheffield, UK
  10. 10Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK
  11. 11Velindre Cancer Centre, Cardiff, UK
  12. 12Institute of Cancer and Genetics, Cardiff University, Cardiff, UK
  1. Correspondence to Dr Annmarie Nelson; nelsona9{at}cardiff.a.c.uk

Abstract

Introduction Radiotherapy treatment for prostate cancer can cause bowel problems, which may lead to severe difficulties for cancer survivors including limiting travel, work or socialising. These symptoms can appear at any time following radiotherapy. This study focuses on the early identification and protocol-based management of effects known to cause long-term, or even permanent, changes to the well-being of prostate cancer survivors. The rationale of this study is to improve the care offered to men and their families following pelvic radiotherapy for prostate cancer.

Method and analysis Implementation research methodology will be used to adopt a multicomponent intervention at three UK centres. The intervention package comprises a standardised clinical assessment of relevant symptoms in oncology outpatient clinics and rapid referral to an enhanced gastroenterological service for patients identified with bowel problems. Gastroenterology staff will be trained to use an expert-practice algorithm of targeted gastroenterology investigations and treatments. The evaluation of the intervention and its embedding within local practices will be conducted using a mixed-methods design. The effect of the new service will be measured in terms of the following outcomes: acceptability to staff and patients; quality of life; symptom control and cost-effectiveness. Data collection will take place at baseline, 6 months (±2 months), and 12 months (±2 months) after entry into the study.

Ethics and dissemination The study has ethical approval from the North West-Liverpool East Research Ethics Committee and the appropriate NHS governance clearance. All participants provide written informed consent. The study team aim to publish the results of the study in peer-reviewed journals as well as at national and international conferences.

Trial registration number UKCRN16974

Statistics from Altmetric.com

Footnotes

  • Twitter Follow Annmarie Nelson at @annmarie0

  • Contributors JS and AN are responsible for the overall design of the study. JA, JG, AM, SA, CF, DC, LS and SP are the coinvestigators. ST, DJJF and WD drafted the manuscript. All authors provided input into the protocol, critical feedback on the manuscript and approved the final manuscript. The study sponsor and funder were not involved in the study design or writing of the protocol.

  • Funding This work is supported by Prostate Cancer UK's True NTH initiative. The funder reference number is 250-55. AN's post is fully supported by Marie Curie Cancer Care core grant funding, grant MCCC-FCO-14-C.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval This study has gained approval from NHS Research Ethics Committee (REC) NRES Committee North West-Liverpool East REC Reference—14/NW/1206 and NHS Research and Development (NHS R&D) approval from the sites.

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

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.