Clinical trial NCT04031586: Delivery of Nutritional Services in Nicaragua
Official title: The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Nicaragua
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition in Cancer Survival and Treatment
Keywords: Malnutrition
Childhood Cancer
Central America
Nicaragua
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with solid tumors in Children's Hospital Manuel de Jesus Rivera (CHMJR) in Nicaragua will be recruited at diagnosis. A total of 300 patients are anticipated for the study in AHOPCA affiliated institution. Patients will be recruited and consented (including parents) by a designated researcher. Demographics is collected from medical records, and other required data will be collected from charts and/or assessed by the designated researcher or clinician. Accrual is anticipated to take place over a 3-year period. All data collection will occur on routine clinical visits or during hospitalization, as per treatment protocol, not requiring otherwise unscheduled visits to the hospital. Determination of time-points coincides with variations in therapy as per the treatment protocols followed by the hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of malnutrition
timeFrame: Up to 3 years
measure: Rate of utilization of nutritional interventions
timeFrame: Up to 3 years
Secondary outcomes:
measure: Cumulative number of grade 3/4 toxicities
timeFrame: Up to 3 years
measure: Survival rate
timeFrame: Up to 3 years
measure: Disease relapse rate
timeFrame: Up to 3 years
measure: Rate of chemotherapy dose reductions
timeFrame: Up to 3 years
measure: Number of treatment delays (in days)
timeFrame: Up to 3 years
measure: Total duration of hospital stay
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Managua
country: Nicaragua
facility: Children's Hospital Manuel de Jesus Rivera (CHMJR)
Study officials:
affiliation: Columbia University
name: Elena Ladas, Phd, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Manuel de Jesus Rivera (CHMJR)
name: Roberta Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References: