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Clinical Trials/NCT03976830
NCT03976830
Completed
Not Applicable

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

Columbia University1 site in 1 country126 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition in Cancer Survival and Treatment
Sponsor
Columbia University
Enrollment
126
Locations
1
Primary Endpoint
Rate of malnutrition
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
October 1, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of childhood cancer (Solid tumors, Acute Lymphoblastic Leukemia (ALL), other Lymphomas)
  • Recruited at diagnosis
  • Under the age of 18 years

Exclusion Criteria

  • Other cancer diagnosis
  • Palliative care patients

Outcomes

Primary Outcomes

Rate of malnutrition

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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