Tele-nutritional collaborative care in patients with stage IV gastrointestinal cancer receiving chemotherapy: A randomized clinical trial.

12043 Background: Cancer cachexia is characterized by systemic inflammation and progressive muscle loss, fundamentally compromising quality of life (QOL) and overall survival. While early nutritional intervention is imperative, patients in resource-constrained regions like Western China often lack timely access. We conducted the tele-nutrition collaborative care (T-NICE) trail to evaluate the efficacy of a hybrid remote care delivery model for patients with stage IV gastrointestinal cancer undergoing chemotherapy. Methods: This randomized clinical trial was conducted at West China Hospital. Patients with histologically confirmed stage IV gastrointestinal cancer (esophageal, gastric, or colorectal) were randomly assigned (1:1) to the T-NICE intervention versus Standard Nutrition Care (SNC). The T-NICE group received a collaborative hybrid telecare model involving a lean team (dietitian and social worker), comprising an initial in person education followed by app-based monitoring and adaptive telephone counseling. Primary Endpoint: The incidence of cancer cachexia (defined as involuntary weight loss >5%, or >2% if BMI <20 kg/m²) over 6 months. Secondary Endpoints: Longitudinal changes in nutritional status (PG-SGA, NRS 2002) and body weight. Exploratory end points included the QOL (using the EORTC QLQ-C30), psychology characteristics (using DT, PHQ-9 and HADS) and caregiver burden (using ZBI). Assessments were conducted at monthly intervals through the six months endpoint. Results: A total of 160 patients were enrolled (80 to T-NICE, 80 to SNC). Cachexia incidence was significantly lower in T-NICE vs. SNC (22.4% VS. 60.8%; adjusted odds ratio aOR, 0.18; 95%CI, 0.09-0.37; P < .001). After six months, weight stabilized in T-NICE group compared to loss in SNC (mean change, +0.86kg 95% CI, -0.20-1.93 VS −3.61 kg 95% CI, -4.70 to -2.52), resulting in a mean difference of -4.56 kg (95% CI, -5.73 to -3.39; P < .001). The T-NICE group also had lower PG-SGA scores (5.10 95%CI, 4.14-6.06 VS 6.50 95%CI, 5.54-7.46; P = .015). T-NICE participants had higher EORTC QLQ-C30 Global Health scores (74.42 vs. 66.67; P = .004) and improved various functional status. Psychological benefits and reduced caregiver burden were also observed. Conclusions: The T-NICE trial demonstrated that an integrated tele-nutrition model significantly reduced cachexia incidence, improved QOL, nutritional status, psychology status and alleviated caregiver burden. Key strengths included the model’s scalability and low staffing requirements, maximizing resource efficiency while delivering substantial clinical benefits. Clinical trial information: NCT06332664 .