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出境医 / 临床实验 / Nutrition in Pediatric Oncology in Central America
Nutrition in Pediatric Oncology in Central America
Study Description
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.
| Condition or disease |
|---|
| Nutrition in Cancer Survival and Treatment |
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Central America |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
Arms and Interventions
| Group/Cohort |
|---|
|
Children diagnosed with cancer
Patients diagnosed with childhood cancer in participating sites in Central American countries
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- Cumulative number of grade 3/4 toxicities [ Time Frame: 3 years ]Investigate association of nutritional status and the occurrence of grade 3/4 toxicities using NCI Common Toxicity Criteria (CTC).
- Survival rate [ Time Frame: 3 years ]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).
- Disease relapse rate [ Time Frame: 3 years ]Investigate the association of nutritional status and disease relapse
- Rate of chemotherapy dose reductions [ Time Frame: 3 years ]The rate of chemotherapy dose reductions will be measured.
- Number of treatment delays (in days) [ Time Frame: 3 years ]The number of treatment delays will be measured in days.
- Readmission rate [ Time Frame: 3 years ]The readmission rate will be measured by the number of readmissions.
- Total duration of hospital stay [ Time Frame: 3 years ]The total duration of hospital stay will be measured in days.
Eligibility Criteria
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with childhood cancer in participating sites in Central American countries specified in the protocol, will be recruited at diagnosis. A total of 1000 patients are anticipated for the study in AHOPCA affiliated institutions. 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 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.
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
Contacts and Locations
Contacts
| Contact: Elena Ladas, Phd, RD | 212-305-7835 | ejd14@cumc.columbia.edu | |
| Contact: Suvekshya Aryal, MPH | 646-317-2070 | sa3234@cumc.columbia.edu |
Locations
| Honduras | |
| Oncologia Pediatrica, Hospital Escuela Universitario, Universidad Nacional Autonoma de Honduras | Recruiting |
| Tegucigalpa, Honduras | |
| Contact: Stephany Zelaya, RD steph_sazel@hotmail.com | |
| Principal Investigator: Armando Peña-Hernandez, MD | |
| Sub-Investigator: Stephany Zelaya, RD | |
Sponsors and Collaborators
Columbia University
Hospital Escuela Universitario, Honduras
Investigators
| Principal Investigator: | Elena Ladas, Phd, RD | Columbia University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 3, 2019 | ||||||||
| First Posted Date | June 6, 2019 | ||||||||
| Last Update Posted Date | June 28, 2019 | ||||||||
| Actual Study Start Date | January 1, 2019 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Nutrition in Pediatric Oncology in Central America | ||||||||
| Official Title | The Role of a Nutritional Program on Delivery of Nutritional Services and Cost of Care in Children With Cancer in Central America | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients diagnosed with childhood cancer in participating sites in Central American countries specified in the protocol, will be recruited at diagnosis. A total of 1000 patients are anticipated for the study in AHOPCA affiliated institutions. 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 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. | ||||||||
| Condition | Nutrition in Cancer Survival and Treatment | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Children diagnosed with cancer
Patients diagnosed with childhood cancer in participating sites in Central American countries
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2022 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Honduras | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03976830 | ||||||||
| Other Study ID Numbers | AAAS1869 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Elena Ladas, Columbia University | ||||||||
| Study Sponsor | Columbia University | ||||||||
| Collaborators | Hospital Escuela Universitario, Honduras | ||||||||
| Investigators |
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| PRS Account | Columbia University | ||||||||
| Verification Date | June 2019 | ||||||||
