Article Text
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
- RADIOTHERAPY
- ONCOLOGY
- GASTROENTEROLOGY
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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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.