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The Impact of a Home Delivered Meal Service in Cancer Patients During Chemotherapy

2020年10月8日 更新者：Radboud University Medical Center

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

148

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 荷兰
    • Gelderland
      • Nijmegen、Gelderland、荷兰、6525 GA
        • Radboudumc

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FoodforCare group
The intervention group will receive meals from FoodforCare at Home. The FoodforCare at Home concept consists of five to six small protein and energy enriched meals that will be delivered twice a week. After an individual intake, the composition of the dishes will be tailored to the needs of the patient in terms of composition, diet, taste, flavor and portion size. Besides the meals, patients in the intervention group will also receive an information leaflet about the importance of protein during treatment and how to reach their protein requirements.
其他：FoodforCare at home
Five small protein rich meals that will be delivered twice a week for 3 weeks.
无干预：Usual care group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Quality of life and overall health status
大体时间：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.
3.5 months

次要结果测量

结果测量
措施说明
大体时间
Nutritional intake
大体时间：3.5 months
2-day food diary filled in before chemotherapy, two times during chemotherapy and after chemotherapy.
3.5 months
Muscle strength
大体时间：3.5 months
Hand grip strength (kg) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
3.5 months
Nutritional status
大体时间：3.5 months
Patient Generated Subjective Global Assessment (PG-SGA) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
3.5 months
Functional score
大体时间：3.5 months
Karnofsky scale performed before chemotherapy, two times during chemotherapy and once after chemotherapy. This status is based on 11 levels and ranges from 0, indicating death, to 100, indicating no complaints or evidence of disease.
3.5 months
Quality of life caregiver
大体时间：3.5 months
Caregiver Reaction Assessment (CRA) filled in before chemotherapy, two times during chemotherapy and once after chemotherapy. This questionnaire consist of 24 items in five subscales. All items are statements with a 5-point Likert scale (completely disagree-completely agree). All subscale scores are the average of the item scores, ranging from 1 to 5. There is no total score.
3.5 months
Medication use
大体时间：3 weeks
Diary filled in during 3 weeks between 2 cycles of chemotherapy
3 weeks
Symptoms
大体时间：3 weeks
Symptom diary filled in during 3 weeks between 2 cycles of chemotherapy
3 weeks
Patient satisfaction
大体时间：1 day
Questionnaire filled in after 3 weeks of receiving meals. This is a self-developed questionnaire which does not have a total score. Each question will be analyzed separately. Questions consist of grading from 0-10 (the higher, the better the outcome) or with a 5-point Likert scale (completely disagree-completely agree).
1 day
Functional status
大体时间：3.5 months
Short Physical Performance Battery (SPPB) performed before chemotherapy, two times during chemotherapy and once after chemotherapy.
3.5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Radboud University Medical Center

调查人员

  • 学习椅：Manon van den Berg, PhD、Radboud University Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年11月17日

初级完成 (实际的)

2020年5月22日

研究完成 (实际的)

2020年5月22日

研究注册日期

首次提交

2017年11月23日

首先提交符合 QC 标准的

2017年12月18日

首次发布 (实际的)

2017年12月22日

研究记录更新

最后更新发布 (实际的)

2020年10月9日

上次提交的符合 QC 标准的更新

2020年10月8日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2016-3044

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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