Delivery of Nutritional Services in Nicaragua

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutrition in Cancer Survival and Treatment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent diagnosis of childhood cancer (Solid Tumors) Recruited at diagnosis Under the age of 18 years Exclusion Criteria: Other cancer diagnosis Palliative care patients

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children diagnosed with Solid Tumors<br>Children diagnosed with solid tumors in Managua, Nicaragua in Central America | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of malnutrition | Determine the change in malnutrition by comparing nutritional status measured by anthropometric data at diagnosis and during and end of treatment. | Up to 3 years | 
| Rate of utilization of nutritional interventions | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of grade 3/4 toxicities | Investigate association of nutritional status and the occurrence of grade 3/4 toxicities using NCI Common Toxicity Criteria (CTC). | Up to 3 years | 
| Survival rate | Survival is defined by both overall survival (time from enrollment to death from any cause) and event-free survival (time from enrollment to the first episode of relapse, disease progression or death). | Up to 3 years | 
| Disease relapse rate | Investigate the association of nutritional status and disease relapse | Up to 3 years | 
| Rate of chemotherapy dose reductions | The rate of chemotherapy dose reductions will be measured. | Up to 3 years | 
| Number of treatment delays (in days) | The number of treatment delays will be measured in days | Up to 3 years | 
| Total duration of hospital stay | The total duration of hospital stay will be measured in days. | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central America, Malnutrition, Childhood Cancer, Nicaragua