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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.
During at least two personal counseling meetings with a dietician, the patient's diet is assessed and individual nutritional interventions - based on the personal needs and individual preferences of the patient - are developed. The overall goal is to optimize protein an energy intake.
Klinikum Konstanz
Konstanz, Germany
Spital STS (Simmental-Thun-Saanenland) AG
Thun, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
QoL
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: 3 Months
Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)
Time frame: 3 months
Nutritional status
Patient-generated subjective global assessment (PGSGA)
Time frame: 3 months
Nutritional status
Bioelectrical impedance analysis (BIA)
Time frame: 3 months
Nutritional status
Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)
Time frame: 3 months
Nutritional status
Calf circumference (in cm)
Time frame: 3 months
Nutritional status
Sarcopenia screening questionnaire SARC-F
Time frame: 3 months
Physical function
Handgrip strength (in kg)
Time frame: 3 months
Physical function
60 s sit-to-stand test (number of stands)
Time frame: 3 months
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In at least two personal counseling meetings with a physiotherapist, the patient's individual training plan is compiled and agreed upon (mainly including strength, endurance and balance exercises). The patient then exercises at home and records the trainings with the app.
Physical function
6 minute walk test (in m)
Time frame: 3 months
Energy- and protein intake
Data collected with application, Harris-Benedict formula
Time frame: 3 months
Fatigue
Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: 3 months
Clinical data
Physical performance status (WHO performance status, grade 0-5)
Time frame: 3 months
Clinical data
Tumor stadium
Time frame: 3 months
Clinical data
Adverse events grade 3 and 4
Time frame: 3 months
Clinical data
Serious adverse events
Time frame: 3 months
Clinical data
Unplanned hospital readmissions
Time frame: 3 months
Clinical data
Survival
Time frame: 3 months
Adherence to the nutritional and exercise program
According to data collected with application
Time frame: 3 months
Usability of the new application
Questionnaire mHealth App Usability (MAUQ)
Time frame: 3 months
Success of recruitment rate in comparison to former studies
Number of eligible patients, participants, rejections as compared to similar past studies
Time frame: Through study completion (24 months)