Nutritional and Metabolic Diseases

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Neoplasms

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Malnutrition

Lung Neoplasms

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Digestive System Neoplasms

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Respiratory Tract Neoplasms

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Lung Diseases

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Quality of Life

Other Dietary Supplements

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Amino Acids

Whey Protein

Leucine

standardized nutritional program including a nutritional supplement

standardized exercise program

app for monitoring.

standard of care

limited version of the app (e.g. without the "help" function).

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.

Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)

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.

Standardized nutritional program

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.

Standardized exercise program

Lucia Gafner, Dr. sc. nat.

Lena Storck, Dr. rer. med.

Acimic Christina

Migle Link, Dr. med.

Lena J Storck, Dr. (rer.) med.

Yvonne Krepp, Dr. med.

Barbara Rohrbach

Christoph Ackermann, Dr. med.

Lena J. Storck, Dr. (rer.) med.

Miklos Pless, Prof. Dr. med.

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.

Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients

Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients

There is no plan to share individual participant data (IPD) with other researchers.

Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)

Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)

Patient-generated subjective global assessment (PGSGA)

Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)

Sarcopenia screening questionnaire SARC-F

60 s sit-to-stand test (number of stands)

Data collected with application, Harris-Benedict formula

Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Physical performance status (WHO performance status, grade 0-5)

According to data collected with application

Questionnaire mHealth App Usability (MAUQ)

Number of eligible patients, participants, rejections as compared to similar past studies

Spots Global Cancer Trial Database for standardized nutritional program