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

Study Overview
=================
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.

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

Conditions
-----------------
Cancer, Gastrointestinal, Cancer, Lung, Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)
* Behavioral: Standardized nutritional program
* Behavioral: Standardized exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring. | Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)<br>* 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.<br>Behavioral: Standardized nutritional program<br>* 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.<br>Behavioral: Standardized exercise program<br>* 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.<br>|
| No Intervention: Control<br>standard of care limited version of the app (e.g. without the help function). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2) | 3 months | 
| Nutritional status | Patient-generated subjective global assessment (PGSGA) | 3 months | 
| Nutritional status | Bioelectrical impedance analysis (BIA) | 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) | 3 months | 
| Nutritional status | Calf circumference (in cm) | 3 months | 
| Nutritional status | Sarcopenia screening questionnaire SARC-F | 3 months | 
| Physical function | Handgrip strength (in kg) | 3 months | 
| Physical function | 60 s sit-to-stand test (number of stands) | 3 months | 
| Physical function | 6 minute walk test (in m) | 3 months | 
| Energy- and protein intake | Data collected with application, Harris-Benedict formula | 3 months | 
| Fatigue | Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3 months | 
| Clinical data | Physical performance status (WHO performance status, grade 0-5) | 3 months | 
| Clinical data | Tumor stadium | 3 months | 
| Clinical data | Adverse events grade 3 and 4 | 3 months | 
| Clinical data | Serious adverse events | 3 months | 
| Clinical data | Unplanned hospital readmissions | 3 months | 
| Clinical data | Survival | 3 months | 
| Adherence to the nutritional and exercise program | According to data collected with application | 3 months | 
| Usability of the new application | Questionnaire mHealth App Usability (MAUQ) | 3 months | 
| Success of recruitment rate in comparison to former studies | Number of eligible patients, participants, rejections as compared to similar past studies | Through study completion (24 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Palliative, Application, Nutrition, Exercise