Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial

Richard Garfinkle, Carmen G Loiselle, Jason Park, Julio F Fiore Jr, Liliana G Bordeianou, A Sender Liberman, Nancy Morin, Julio Faria, Gabriela Ghitulescu, Carol-Ann Vasilevsky, Sahir R Bhatnagar, Marylise Boutros, Richard Garfinkle, Carmen G Loiselle, Jason Park, Julio F Fiore Jr, Liliana G Bordeianou, A Sender Liberman, Nancy Morin, Julio Faria, Gabriela Ghitulescu, Carol-Ann Vasilevsky, Sahir R Bhatnagar, Marylise Boutros

Abstract

Introduction: Low anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial.

Methods and analysis: This will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team, and was vetted in a focus group and semistructured interviews involving patients, caregivers, and healthcare professionals. The primary outcome will be global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), at 6 months after surgery. The treatment effect on global QoL will be modelled using generalised estimating equations. Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.

Ethics and dissemination: The Research Ethics Committee (REC) at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) is the overseeing REC for all Quebec sites. They have granted ethical approval (MP-05-2019-1628) for all Quebec hospitals (Jewish General Hospital, McGill University Health Center, CHU de Quebec) and have granted full authorisation to begin research at the Jewish General Hospital. Patient recruitment will not begin at the other Quebec sites until inter-institutional contracts are finalised and feasibility/authorisation for research is granted by their respective REC. The results of this study will be presented at national and international conferences, and a manuscript with results will be submitted for publication in a high-impact peer-reviewed journal.

Trial registration number: NCT03828318; Pre-results.

Keywords: adult gastroenterology; colorectal surgery; epidemiology; gastrointestinal tumours.

Conflict of interest statement

Competing interests: ASL receives travel stipends from Merck and Servier, and is on the advisory committee of Novadaq. JFFJ received a research grant from Merck and fees for consulting from Shionogi.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study timeline for patients in the LARS patient-centred programme. LARS, low anterior resection syndrome.
Figure 2
Figure 2
Study timeline for patients in the standard care group. LARS, low anterior resection syndrome.

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