Effect of a Mobile Health–Based Remote Interaction Management Intervention on the Quality of Life and Self-Management Behavior of Patients With Low Anterior Resection Syndrome: Randomized Controlled Trial

Abstract

Background: People who undergo sphincter-preserving surgery have high rates of anorectal functional disturbances, known as low anterior resection syndrome (LARS). LARS negatively affects patients' quality of life (QoL) and increases their need for self-management behaviors. A high level of self-management behavior effectively improved the impact of LARS on patients. Therefore, approaches to enhance self-management behavior and QoL are vital.Objective: This study aimed to assess the effectiveness of a remote interactive management intervention designed to enhance the QoL and self-management behavior of patients with LARS.Methods: From July 2022 to May 2023, we conducted a single-blinded randomized controlled trial (RCT) and recruited 120 patients with LARS in a tertiary hospital in Hefei, China. All participants were randomly assigned to the intervention group (using the 'e-bowel safety' applet and monthly Motivational interviewing) or the control group (usual care and an information booklet). Our team provided a 3-month intervention and followed up with all participants for an additional 3 months. The primary outcome was patient QoL measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC-QLQ-C30). The secondary outcomes were evaluated using the Bowel Symptoms Selfmanagement Behaviors Questionnaire (BSSBQ), LARS Score, and Perceived Social Support Scale (PSSS). Data collection occurred at study enrollment, the end of the three-month intervention, and the three-month follow-up. Results:In the end, 111 participants completed the study. In the intervention group, 5 participants withdrew; 4 participants withdrew in the control group. Compared with the participants in the control group, those in the intervention group had significantly larger improvements in the EORTC-QLQ-C30 total score (mean difference 11.51, 95% CI 10.68-12.35, Cohen's d=1.73) and BSSBQ total score (mean difference 8.80, 95% CI 8.28-9.32, Cohen's d=1.94) after intervention, and this improvement effect remained stable at 3-month follow-up (mean difference 14.47, 95% CI 13.65-15.30, Cohen's d=1.58), (mean difference 8.85, 95% CI 8. Cohen's d=2.23). The LARS Score total score had significantly larger decreases after intervention (mean difference -3.28, 95% CI -4.03 to -2.54, Cohen's d=-0.39) and at 3-month follow-up (mean difference -6.69, 95% CI -7.45 to -5.93, Cohen's d=-0.69). The PSSS total score had significantly larger improvements after intervention (mean difference 0.47, 95% CI 0.22-0.71, Cohen's d=1.81); however, this effect did not persist at 3-month follow-up (mean difference 0.23, 95% CI -0.20 to 0.45; P=0.074).