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

IntroductionRadiotherapy 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 analysisImplementation 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 disseminationThe 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 numberUKCRN16974

Late radiation-induced bowel syndromes, tobacco smoking, age at treatment and time since treatment – gynecological cancer survivors

“…We started the observation three years after the radiotherapy and possibly the patho-physiological processes leading to urgency-related symptoms at that time had reached a steady level or diminished. Taking drugs like sterculia gum, increasing stool consistency and skipping meals are, according to clinical experience, ways to decrease the intensity of the urgency syndrome [22]. Possibly a major reason for the decreased intensity is that the survivors learn to cope with their urgency-related symptoms by varying means.…”

The ALERT-B questionnaire: A screening tool for the detection of gastroenterological late effects after radiotherapy for prostate cancer

“…All statistical calculations were carried out using SPSS V23. (More details relating to ''materials and methods" for this study have previously been published [13]).…”

“…Despite the significant impact that these bowel habit changes can have on quality of life, only one in five patients who develop gastrointestinal (GI) symptoms after pelvic radiotherapy are referred to a gastroenterologist [12]. A discussion of the possible reasons for this is given in a protocol paper for the EAGLE study [13], which aims to implement an innovative service to improve the care offered to men diagnosed with prostate cancer. The Optimising Radiotherapy Bowel Injury Therapy (ORBIT) trial [14] demonstrated that these symptoms can be diagnosed accurately and that they can be treated effectively at very modest cost compared to the cost of the cancer treatment itself, and that this approach leads to improvements in pelvic radiation-induced GI symptoms as measured by Inflammatory Bowel Disease Questionnaire-Bowel (IBDQ-B) scores.…”

The Trigger Project: The Challenge of Introducing Electronic Patient-Reported Outcome Measures Into a Radiotherapy Service

“…We continue to use a learning in practice approach through surveys of staff and by speaking to sites directly. The higher levels within Velindre could be predicted due to their specialist interest in pelvic radiation disease for more than 5 years [15] evident in Brighton and Imperial, who have smaller teams of on-treat radiographers/nurses. This system is designed to help those patients significantly affected by pelvic radiation disease after 6 months and point them to the right help more effectively and quickly.…”