JMIR Publications

ABSTRACT

Background:

Nutritional and exercise interventions have shown beneficial effects after gastrectomy for gastric cancer. While digital health tools show promise in cancer care, their long-term effectiveness in patients with gastric cancer remains unclear. In addition, large-scale studies of personalized interventions initiated in the immediate postoperative period are lacking.

Objective:

This study aimed to determine whether a personalized mobile health intervention incorporating exercise and nutrition confers additional benefits in weight change, body composition, nutritional status, physical fitness and quality of life compared with standard care when applied continuously for 12 months after gastrectomy.

Methods:

This multicenter, randomized controlled trial enrolled 257 individuals who had undergone curative resection for stage I–III gastric cancer. Participants were randomly assigned (2:1) to either a 12-month personalized mobile health intervention group or a standard rehabilitation control group. The digital intervention incorporated a smartphone application and wearable device, offering exercise and dietary plans tailored to clinical parameters such as body mass index, surgery type, and recovery stage. Standard care, including nutritional education, was provided to all patients. The primary outcome was a change in body weight over 12 months. Secondary outcomes included quality of life (EORCT-QLQ-C30, EORTC-QLQ-STO22), nutritional status (MNA score), physical fitness (grip strength, 30-s chair stand, 2-min walk), physical activity (IPAQ-SF), pain intensity (average NRS), body composition (skeletal muscle mass, lean body mass, fat mass), body mass index, hemoglobin, vitamin B, and albumin. Assessments were conducted at baseline and at 1, 3, 6, and 12 months postoperatively.

Results:

No significant group-by-time effects were observed for weight change. Secondary outcomes showed no between-group differences, except for one subscale of the EORTC QLQ-C30, without clinical significance. The intervention group reported high satisfaction and adherence to the mobile application, and no adverse events or incidents were observed during the 12-month study period.

Conclusions:

Digital health was not superior to the standard education in modifying the postoperative trajectory of gastric cancer after surgery. These findings suggest that future digital health programs should be precisely targeted and tailored to specific patient populations and recovery phases. To our knowledge, this is the first randomized clinical trial to evaluate a personalized, treatment stage-adjusted digital intervention using wearable devices in a large cohort of patients with gastric cancer, implemented over the first year of postoperative rehabilitation. Clinical Trial: Clinicaltrials.gov identifier: NCT04907591 (registration date: June 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04907591).