Patient-Reported Outcome-Based Symptom Management Improves Quality of Life in Postoperative Gastroesophageal Cancer Patients: A Randomized Controlled Trial.

Abstract

Introduction: Following resection for gastroesophageal cancer, patients may experience symptoms like reflux, anorexia, and weight loss that can significantly impact their quality of life (QoL). Patient-reported outcomes (PROs) are becoming more important for symptom monitoring. Nevertheless, there is limited knowledge on symptom management post-gastroesophageal cancer resection.

Methods: A single-center, randomized controlled trial was conducted on postoperative patients with gastroesophageal cancer. Participants were randomly assigned to the PRO group and usual care (the control group), with a 1:1 ratio. The PRO-based symptom management included symptom assessment, monitoring, and personalized interventions such as lifestyle guidance, nutritional support, and drug therapy. An electronic system was developed on the Research Electronic Data Capture (REDCap) platform to monitor and assess patients' symptoms, QoL, and provide diagnosis and treatment. The study focused on five key symptom events: anorexia, reflux, depression, nutritional risk, and underweight. In the PRO group, assessments were conducted every 3-4 weeks for a minimum of 16 weeks. Interventions for this group primarily involved counseling, patient education, and medication prescriptions based on individual symptoms. The control group's symptoms and QoL were assessed only at baseline and week 16. The primary outcome measure was the total number of symptoms at 16 weeks, with secondary outcomes including the incidence of symptoms at the same time point. QoL was also evaluated as part of the study.

Results: Between April 2021 and May 2022, a total of 124 patients were divided into two groups: 60 in the PRO group and 64 in the control group. The PRO group exhibited notably fewer overall symptoms at the 16-week mark compared to the control group (1.20 ± 1.16 vs. 2.50 ± 1.47), along with a lower prevalence of nutritional risk (63.3% vs. 81.3%), anorexia (18.3% vs. 60.9%), reflux (13.3% vs. 57.8%), and depression (5.0% vs. 20.3%). The QoL scores were markedly higher in the PRO group. Furthermore, the PRO group displayed lower nutritional status, reflux, and depression scale trends, as well as higher anorexia trends when compared to the control group.

Conclusions: PRO-based symptom management led to superior symptom control and enhanced QoL in postoperative gastroesophageal cancer patients when compared to standard care.