Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- QoL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
QoL
时间窗: 3 Months
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
次要结局
- 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))
- Nutritional status(3 months)
- Physical function(3 months)
- Clinical data(3 months)