Meals on Wheels, a Randomized Controlled Study on the Effect of a Home Food-delivery Service for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
The overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.
详细描述
Despite the fact that nutritional deterioration has been associated with patients' functional impairment, the effect of individualized nutritional support or counselling to outpatients, focussing on ordinary food, have not yet been thoroughly explored (Ravasco P. et al. 2007). A few studies have investigated the effect of nutritional counselling on quality of life (QoL) in cancer patients after discharge (Ovesen et al. 1993, Persson et al. 2002, Isenring et al. 2004, Ravasco et al. 2005a, Ravasco et al. 2005b). However, there is to our knowledge not conducted any studies examining the effect of home delivered meals on QoL and other endpoints in outpatients suffering from cancer.
The overall objective of the study is to measure the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished outpatients diagnosed with lung cancer. The intervention diet will consist of optional protein- and energy-dense main and in-between-meals. There will be 22 different main meals and 13 in-between meals to choose between. The meals are prepared by The Nordic Kitchen of Copenhagen University Hospital Herlev. The offered main meals will consist of a selection of warm dishes taken from the ordinary menu. The in-between meals are a collection of the Delights of Herlev (dishes previously shown to increase dietary intake among in-patients). The food will be delivered to the participants' home 3 times per week, and participants can order one warm dish and ad libitum in-between meals for each day.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a nutritional risk score ≥ 3 according to NRS-2002 (Kondrup J. et al. 2003)
- •Be diagnosed with lung cancer
- •Have a life expectancy > 12 weeks
- •Not plan to loose weight or go on a diet
- •Not plan to go on vacation for > 2 weeks during the study period
- •Live at their own home
- •Live ≤ 25 km from the hospital
- •Be able to read, write and understand Danish
排除标准
- •Receives food from a food-delivery service
- •Have food allergies or intolerance
- •Exclusively receives enteral or parenteral nutrition
- •Suffers from cognitive impairment e.g. dementia
- •Is terminal
结局指标
主要结局
Quality of Life
时间窗: 12 weeks (change from baseline)
To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used.
次要结局
- Hand grip strength(6, and 12 weeks (changes from baseline))
- 30-second chair-stand test(6, and 12 weeks (changes from baseline))
- Body Weight(6, and 12 weeks (changes from baseline))
- Depression Scale(6, and 12 weeks (changes from baseline))
- Total energy- and protein intake per day(6, and 12 weeks (changes from baseline))
- Re-admissions with total length of stay (LOS)(12 weeks, and 6 months)
- Mortality(12 weeks, and 6 months)
- WHO Performance status(6, and 12 weeks)
- Functional-score(6 and 12 weeks)
- Symptom-score(6 and 12 weeks (changes from baseline))
研究者
Christian Bitz
Head of Reseach
Copenhagen University Hospital at Herlev