The impact of an interactive online informational and peer support application (app) for patients with low anterior resection syndrome (LARS) on quality of life: a multicenter randomized controlled trial

Introduction Low Anterior Resection Syndrome (LARS) describes bowel dysfunction post-restorative proctectomy (RP) and is associated with poor quality of life (QoL). The aim of this study was to assess the impact of an interactive online informational and peer support App on participants’ QoL (primary outcome), LARS, and emotional distress (secondary outcomes). Methods A multicentre, randomized, parallel-group trial was conducted across five Canadian colorectal surgery practices. Adult patients who: (1) underwent RP for rectal cancer and completed all treatment and (2) had major/minor LARS were included. Participants were randomized in a 1:1 ratio to treatment or comparison group, stratified by hospital site and years post-RP. The treatment group had access to the App for a period of 6 months, and the comparison group received a booklet containing the same educational material as the App. The primary outcome was change in global QoL (EORTC-QLQ-C30) from baseline to 6 months post-intervention. Per-protocol and intention to treat analysis were performed, controlling for a priori selected variables (sex, time from end of treatment). Results Of the 101 enrolled participants, 10 individuals were lost to follow-up and 91 completed the study. Participants were well-balanced in terms of baseline characteristics, QoL and bowel dysfunction. Among the 45 App users, median log-in per person was 21, with 30 (66.7%) participants meeting criteria for adequate app usage. On intention to treat analysis, there was no statistically significant difference in QoL in the App group. On the per-protocol analysis, where only participants who met adequate App usage criteria were included in the treatment group, the group reported statistically significant improvement in QoL (β 9.5, 95% CI 4.6,14.6) and LARS (β − 2.7, 95%CI − 5.1,− 0.2) scores following App usage. Conclusion This multicenter randomized controlled trial support that, when adequately used, an interactive online informational and peer support App has the potential to improve QoL of rectal cancer survivors living with LARS post-RP.