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临床试验/NCT04031586
NCT04031586已完成不适用

The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Nicaragua

Columbia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月5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
50
试验地点
1
主要终点
Rate of malnutrition

研究概览

简要总结

This study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under Asociación de Hemato-Oncología Pediátrica de Centro América (AHOPCA) consortium in Central America. The aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in Central America.

详细描述

In low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. Without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. Studies have shown that more than half of the children with cancer are also malnourished at diagnosis. This increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. With an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in Central America where the cancer rates and malnutrition is high, as shown by several studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Recent diagnosis of childhood cancer (Solid Tumors)
  • Recruited at diagnosis
  • Under the age of 18 years

排除标准

  • Other cancer diagnosis
  • Palliative care patients

结局指标

主要结局

Rate of malnutrition

时间窗: Up to 3 years

Determine the change in malnutrition by comparing nutritional status measured by anthropometric data at diagnosis and during and end of treatment.

Rate of utilization of nutritional interventions

时间窗: Up to 3 years

Impact on the delivery of nutritional services, defined as utilization of nutritional interventions. Information on utilization of nutritional services will be collected on a medical nutrition support (MNS) case report form, which collects information on the provision of enteral feeds (nasogastric feeds, gastrostomy feeds), oral nutrition supplements (e.g. Pediasure®, Ensure®) and days of total parenteral nutrition (TPN) over the previous phase of treatment. The MNS form also provides information on the brand of nutritional formula and the prescribed dose (i.e. amount in grams of supplement per day). If enteral feeds are administered, the formula, rate, and duration are reported. The responses collected on the MNS form will be used to determine the rate of utilization of nutritional interventions.

次要结局

  • Cumulative number of grade 3/4 toxicities(Up to 3 years)
  • Survival rate(Up to 3 years)
  • Rate of chemotherapy dose reductions(Up to 3 years)
  • Total duration of hospital stay(Up to 3 years)
  • Disease relapse rate(Up to 3 years)
  • Number of treatment delays (in days)(Up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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