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临床试验/NCT03382171
NCT03382171已完成不适用

The Impact of FoodforCare at Home on Quality of Life of Cancer Patients Undergoing Chemotherapy.

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2017年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Quality of life and overall health status

研究概览

简要总结

Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care.

详细描述

Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. Several studies suggest that nutritional intake increases when the patient is satisfied about the quality of the meals. Therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. In this vein, the investigators hypothesize that meals from FoodforCare at Home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care. Also, the investigators expect that this strategy will have a positive effect on patient satisfaction, other nutrition-related issues, including nausea and vomiting, on nutritional intake per se and hence, on the nutritional status. Additional benefits might include reduced use of medication, especially anti-emetics.

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

入选标准

  • age 18 years or older
  • diagnosed with cancer
  • receiving chemotherapy according to a minimum schedule of every 2 weeks
  • living within a 40 km radius around the Radboud University Nijmegen Medical Centre
  • written informed consent

排除标准

  • renal insufficiency (MDRD-GFR (glomerular filtration rate) < 60ml/min and/or proteinuria)*
  • dementia or any other condition which makes it impossible to fill out questionnaires correctly
  • unable to understand or speak Dutch
  • depending on artificial nutrition in the form of Oral Nutritional Supplements, tube feeding or total parenteral nutrition
  • swallowing or passage problems
  • proteinuria is defined in case of a protein creatinine ratio > 0.5g/10mmol or an albuminuria > 300mg/day. This is checked by default before the start of chemotherapy by the treating physician to decide whether or not the patient is eligible for receiving chemotherapy.

结局指标

主要结局

Quality of life and overall health status

时间窗: 3.5 months

EORTC-Quality of Life-C30 questionnaire filled in before chemotherapy, two times during chemotherapy and after chemotherapy. This questionnaire consists of 30 questions and a total score ranging from 0-100 is calculated based on these questions. The higher the score, the higher the quality of life of the patient.

次要结局

  • Nutritional intake(3.5 months)
  • Muscle strength(3.5 months)
  • Nutritional status(3.5 months)
  • Functional score(3.5 months)
  • Quality of life caregiver(3.5 months)
  • Medication use(3 weeks)
  • Symptoms(3 weeks)
  • Patient satisfaction(1 day)
  • Functional status(3.5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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