Digital and AI-assisted multimodal supportive care, combining physical activity, nutrition, and pain management during chemotherapy for advanced pancreatic cancer patients: study protocol of the European multicenter randomized controlled trial of the RELEVIUM project

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BACKGROUND: Multimodal care, including nutritional support, physical exercise, and pain management, is essential to address complex therapeutic challenges in advanced pancreatic cancer. There is an increasing prevalence worldwide in pancreatic cancer and the disease is often diagnosed late leading to limited treatment options and poor prognosis. Advanced pancreatic cancer patients experience a wide range of adverse symptoms that affect their quality of life and require comprehensive and interdisciplinary patient care early in treatment. Integrating digital health, particularly through remote monitoring, plays a vital role in addressing the therapeutic challenges and improving data-driven clinical decision-making. Therefore, the European project RELEVIUM examines the effect of a personalized, digitally assisted multimodal supportive care intervention on health-related quality of life in patients with pancreatic cancer aiming to improve early access to multidisciplinary, cost-effective palliative care. METHODS: In cancer centers in Estonia, Israel, and Germany, 132 patients will be randomly assigned in the prospective randomized controlled trial RELEVIUM-RCT into two groups. Both groups receive standard chemotherapy. The control group follows usual care, while the intervention group receives personalized, digitally assisted multimodal support integrated into usual care. The intervention includes guidance and monitoring on pain, nutrition, fatigue, sarcopenia, and physical activity. Patients track their physical activities, nutritional behavior and rate pain and fatigue daily via a smartwatch and mobile app. The physician analyses these longitudinal data on a dashboard and counsels the patients every two weeks during clinical visits, assisted by an interdisciplinary team and digital support system. The primary endpoint of the study is health-related quality of life including factors such as time until a definitive deterioration in selected dimensions (physical functioning and/or appetite loss) assessed at 8 weeks. Secondary endpoints include longitudinal analyses of efficacy related to pain, physical function, nutrition, sarcopenia, and socioeconomic factors. DISCUSSION: The RELEVIUM-RCT investigates the efficacy of digital health support for individuals with advanced pancreatic cancer in conjunction with conventional treatments in three European countries. Longitudinal data on the interplay of chemotherapy toxicity, fatigue, pain, physical activity, and nutrition will provide valuable extended insights on multimodal pancreatic cancer care. Moreover, this data can help demonstrate the benefits of digital health in clinical decision-making, ultimately contributing to improved quality of care in Europe. TRIAL REGISTRATION: Registry: German Clinical Trials Register; Registration number: DRKS00037143; Date of registration: 5th of June 2025.

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