Interactive Online Informational and Peer Support Application for Patients with Low Anterior Resection Syndrome: Patient Survey and Protocol for a Multicenter Randomized Controlled Trial

AIM Low Anterior Resection Syndrome (LARS) refers to a constellation of bowel symptoms that affects the majority of patients following restorative proctectomy. LARS is associated with poorer quality of life (QoL), and can lead to distress, anxiety and isolation. Peer support could be an important resource for people living with LARS, helping them normalize and validate their experience. This manuscript describes the development of an interactive online informational and peer support app for LARS and the randomized controlled trial protocol. METHOD A multicenter, randomized, assessor-blind, parallel-groups, pragmatic trial will be used involving patients from 5 large colorectal surgery practices across Canada. The trial will evaluate the impact of an interactive online informational and peer support app for LARS, consisting of LARS informational modules and a closed forum for peers and trained peer support mentors, on patient-reported outcomes of people living with LARS. The primary outcome will be global QoL at 6 months following app exposure. The treatment effect on global QoL will be modeled using generalized estimating equations. Secondary outcomes will include patient activation and bowel function as measured by LARS scores. ETHICS AND DISSEMINATION This study has been granted ethical approval (MP-05-2020-2073) from the lead investigating site. The results 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.