Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
- Conditions
- Cancer, GastrointestinalCancer, LungMalnutrition
- Interventions
- Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)Behavioral: Standardized nutritional programBehavioral: Standardized exercise program
- Registration Number
- NCT04859400
- Lead Sponsor
- Kantonsspital Winterthur KSW
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Advanced lung or gastrointestinal cancer patients not eligible for curative treatment
- WHO performance status of ≤ 2
- Able to perform physical exercise estimated by the treating physician
- Estimated life expectancy of ≥ 6 months
- Patient must give written informed consent
- Intake of supplements with high-dose branched-chain amino acids within one month
- Enteral (except oral nutritional supplements) and/or parenteral nutrition within one month
- History of ileus within previous month
- Milk protein allergy
- The patient cannot understand the trial-specific content due to linguistic, psychological or disease reasons
- Age < 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Standardized nutritional program standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring. Intervention Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring. Intervention Standardized exercise program standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring.
- Primary Outcome Measures
Name Time Method QoL 3 Months Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
- Secondary Outcome Measures
Name Time Method Physical function 3 months 6 minute walk test (in m)
Energy- and protein intake 3 months Data collected with application, Harris-Benedict formula
Fatigue 3 months Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Adherence to the nutritional and exercise program 3 months According to data collected with application
Usability of the new application 3 months Questionnaire mHealth App Usability (MAUQ)
Success of recruitment rate in comparison to former studies Through study completion (24 months) Number of eligible patients, participants, rejections as compared to similar past studies
Nutritional status 3 months Sarcopenia screening questionnaire SARC-F
Clinical data 3 months Survival
Trial Locations
- Locations (3)
Klinikum Konstanz
🇩🇪Konstanz, Germany
Spital STS (Simmental-Thun-Saanenland) AG
🇨🇭Thun, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland