Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kantonsspital Winterthur KSW
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- QoL
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
standard of care
limited version of the app (e.g. without the "help" function).
Intervention
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) (Dietary Supplement)
Intervention
standardized nutritional program including a nutritional supplement
standardized exercise program
app for monitoring.
Intervention: Standardized nutritional program (Behavioral)
Intervention
standardized nutritional program including a nutritional supplement
standardized exercise program
app for monitoring.
Intervention: Standardized exercise program (Behavioral)
Outcomes
Primary Outcomes
QoL
Time Frame: 3 Months
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
Secondary Outcomes
- Nutritional status(3 months)
- Physical function(3 months)
- Clinical data(3 months)
- Energy- and protein intake(3 months)
- Fatigue(3 months)
- Adherence to the nutritional and exercise program(3 months)
- Usability of the new application(3 months)
- Success of recruitment rate in comparison to former studies(Through study completion (24 months))