Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Malnutrition_PGSGA
研究概览
简要总结
Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head and neck cancer
- •Older than 18 years
排除标准
- •Patients admitted with the classification of malignant tumors (TNM) stage 4
- •Terminal condition (life expectancy < 6 months)
- •Patients who do not understand the Norwegian language.
结局指标
主要结局
Malnutrition_PGSGA
时间窗: 18 weeks
Measured by the: Patient-Generated Subjective Global Assessment (PG-SGA). The tool categories participants into: category A (Well-nourished), B (Moderately malnutrition or possible malnutrition), or C (serious malnutrition)
次要结局
- Malnutrition GLIM(18 weeks)
- Nutrition intake(18 weeks)
- Health-related quality of life(18 weeks)
- Number of Participants compliant to the intervention(18 weeks)
- Number of patients with non-elective readmissions(18 weeks)
- Weight change(18 weeks)
- Body composition(18 weeks)
研究者
Christine Henriksen
Associate professor
University of Oslo