A Multicenter Pilot Randomized Controlled Trial of a Digital Symptom Management Platform (WECARE) for Gastric Cancer Survivors

초록

Background: Gastric cancer survivors frequently encounter a "care gap" after discharge because of complex postgastrectomy syndromes. We evaluated "WECARE," a bidirectional digital health platform designed to provide real-time symptom monitoring and multidisciplinary support. The primary goal of this study was to assess the efficacy of the platform by measuring the change in the Korean Quality of Life Questionnaire for Gastric Cancer Survivors (KOQUSS-40) total score over a six-month recovery period. Methods: This nationwide, multicenter pilot randomized controlled trial was conducted by the Korean Quality of Life in Stomach Cancer Patients Study Group (KOQUSS) across nine tertiary centers in Korea. A total of 88 patients who underwent curative gastrectomy were enrolled. Following an initial optimization phase involving 22 patients, the remaining 66 patients were randomized at a 1:1 ratio to the WECARE group or the control group. The WECARE group used a platform integrating the KOQUSS-40 algorithm for structured symptom reporting, real-time feedback on nutrition and exercise, and educational content on meal planning, symptom coping, and recovery. Assessments were performed at baseline and at 1, 3, and 6 months after discharge. Results: The WECARE group showed high feasibility and acceptability, with an adherence rate of 86.7% and an 82% satisfaction rate. At 6 months, the KOQUSS-40 total score (primary endpoint) did not differ significantly between the WECARE and control groups (85.3 +/- 1.6 vs. 83.8 +/- 1.6, p = 0.603). However, the WECARE group showed a numerically favorable recovery trajectory from the acute postoperative phase. Subgroup analysis revealed a positive trend in reflux symptom management in the WECARE group (p = 0.0856). In addition, more than 77% of users reported that the platform improved their self-management capabilities. Conclusions: The WECARE platform is a feasible and acceptable digital intervention for gastric cancer survivors. Although the primary endpoint was not significantly different, the favorable recovery trajectory, high adherence, and patient engagement support further evaluation in larger studies with longer follow-up and broader healthcare settings.

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