Malnutrition Clinical Trial
Official title:
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
The main purpose of the study is to investigate whether a tailor-made nutritional and exercise program including home-based sessions and regular monitoring using an application on the smartphone is effective in improving Quality of Life in patients with advanced lung or gastrointestinal tract cancer.
Cachexia is highly prevalent among cancer patients and has substantial impact on the Quality of Life (QoL) and the functional status of patients.Therefore, the main purpose of this study is to investigate whether a mainly home-based nutritional and exercise program including regular monitoring using an application on the smartphone is effective in improving QoL in patients with advanced lung or gastrointestinal tract cancer. The study desing is a randomized, two-arm and multicenter international trial and advanced lung or gastrointestinal cancer patients not eligible for curative treatment make up the patient population. Patients in the intervention group receive a nutrition and exercise program in combination with an electronic application for data collection and monitoring. The nutritional program comprises an extensive nutritional assessment and an individual nutritional recommendation. In addition, patients receive a whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) to support an optimal protein intake in combination with physical activity. The nutritional situation is reassessed at 2 -3 weeks. Exercise counselling includes at least two visits with an extensive first baseline assessment. On this basis, an individual training program for 12 weeks in a home-based setting is compiled, with mainly strength and endurance exercises. At week 2-3, the patient and the study physiotherapist have a follow-up meeting. The application Swiss NutriAct is mainly used for data collection (nutritional, exercise and QoL data). Since the study coordinator, dietician and physiotherapist can see the information entered by the intervention group patients, they can contact patients and offer help regarding the nutrition and exercise program, where deemed appropriate. Vice versa, patients can use the help button to contact the study team to ask questions regarding the nutrition and exercise program. Patients in the control group receive standard of care and a limited version of the application. Both arms will be assessed at baseline (0 weeks), after the 12 weeks intervention phase and at a follow up assessment after 24 weeks. ;
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