title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  UKCRN16974.
authors.affiliation: Marie Curie Palliative Care Research Centre, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: Sophia
authors.initials: S
authors.lastname: Taylor
authors.affiliation: Specialist Unit for Review Evidence, Cardiff University, Cardiff, UK.
authors.forename: Weyinmi
authors.initials: W
authors.lastname: Demeyin
authors.affiliation: Gastroenterology Unit, Royal Marsden Hospital, London, UK.
authors.forename: Ann
authors.initials: A
authors.lastname: Muls
authors.affiliation: Department of Oncology, Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Ferguson
authors.affiliation: School of Dentistry, Cardiff University, Cardiff, UK.
authors.forename: Damian J J
authors.initials: DJ
authors.lastname: Farnell
authors.affiliation: Faculty of Life Sciences and Education, Health Economics and Policy Research Unit (HEPRU), University of South Wales, Cardiff, UK.
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.affiliation: Gastroenterology Unit, Royal Marsden Hospital, London, UK.
authors.forename: Jervoise
authors.initials: J
authors.lastname: Andreyev
authors.affiliation: Department of Gastroenterology, University Hospital of Llandough, Cardiff, UK.
authors.forename: John
authors.initials: J
authors.lastname: Green
authors.affiliation: Macmillan Cancer Support, London, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Smith
authors.affiliation: Department of Oncology, University of Sheffield, Sheffield, UK.
authors.forename: Sam
authors.initials: S
authors.lastname: Ahmedzai
authors.affiliation: Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Pickett
authors.affiliation: Marie Curie Palliative Care Research Centre, School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
authors.affiliation: Velindre Cancer Centre, Cardiff, UK Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: John
authors.initials: J
authors.lastname: Staffurth
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000465:Algorithms; D000554:Ambulatory Care Facilities; D001291:Attitude of Health Personnel; D003362:Cost-Benefit Analysis; D042241:Early Diagnosis; D005762:Gastroenterology; D006296:Health Services; D006297:Health Services Accessibility; D006801:Humans; D007410:Intestinal Diseases / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy; D007422:Intestines / Q000528:radiation effects; D008297:Male; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects*; D012017:Referral and Consultation; D006113:United Kingdom
keywords: GASTROENTEROLOGY; ONCOLOGY; RADIOTHERAPY