PRO-based symptom management versus usual care for patients with gastric and esophageal cancer who undergone previous surgery: A randomized controlled trial.

Abstract

e16104 Background: In China, the incidence of gastric cancer and esophageal cancer ranks second and third, respectively. These patients often suffer from malnutrition, anorexia and gastroesophageal reflux, which have a serious implication on their subsequent treatment. However, due to the specificity of the current medical situation in China and the heavy treatment workload of clinicians, there is no efficient and easy way to manage the symptoms of these patients. Methods: Subjects were randomized in a 1:1 ratio after enrollment into the Patient-Reported Outcome (PRO) -based symptom management group and the usual care group. The PRO group were assessed for anorexia, gastroesophageal reflux, nutritional status, BMI in the hospital before each cycle of chemotherapy via an electronic data platform. The doctors responded the assessment results and provided interventions, including advice for home care, drug prescription, and telephone follow-up, before patients are discharged from the hospital. Patients were assessed and managed every 3-4 weeks at the time of return for chemotherapy during 16 weeks. Patients in the usual care group underwent symptom assessment only the first and the 16th weeks, during which the surgeons only managed the symptoms with usual care modalities. The primary endpoint is number of symptoms at the 16th weeks and the secondary endpoint are the incidence of each symptom at the 16th weeks. Results: The interim results of the trial is reported. From Apr 2021 to Dec 2021, 55 pts completed the clinical observation, including 25 pts in the PRO group and 30 pts in the usual care group. The number of overall symptoms in the PRO group was significantly lower than in the usual care group (1 (0-1.5) vs 2 (1-3)). The incidence of nutrition risk (28.0% vs 56.7%), anorexia (24.0% vs 60.0%) and gastroesophageal reflux(8.0% vs 50.0%) in the PRO group was significantly lower than that in the usual care group, and there was no statistically significant difference about underweight (defined: BMI<18.5, 24.0% vs 36.7%) and depression (0.0% vs 6.7%). Conclusions: Compared to usual care, nutritional risk, anorexia, and GERD rates were effectively controlled in patients with previously surgically resected gastric and esophageal cancers through 16 weeks of patient-reported outcome based symptom management, with assessment scores confirming the same results, providing clinicians with an easy-to-operate and effective means of symptom management. Clinical trial information: ChiCTR2100041701. [Table: see text]