- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665691
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
April 24, 2017 updated by: St. Jude Children's Research Hospital
Researchers are studying ways to predict if cancer patients are at risk for poor nutrition during their chemotherapy treatment.
They hope to identify children with nutrition problems early in treatment.
This may help prevent weight loss and other nutrition problems later in treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The PEDSGA is a newly developed nutrition tool that includes a training manual that be used to teach health care professionals to identify at-risk patients by doing a nutrition physical exam.
The PEDSGA also includes questions that the patient/caregiver answers regarding appetite, recent treatment, and activity level.
This method of screening is new and may be able to identify at-risk patients better than the standard method.
This study will use both methods and evaluate the two, in hope of determining which method works best to identify at-risk patients.
Study Type
Observational
Enrollment (Actual)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participant is between 2 and 16 years of age and receiving treatment for a hematologic or solid malignancy at St. Jude Children's Research Hospital.
Description
Inclusion Criteria:
- St. Jude Children's Research Hospital patient between 2 and 16 years of age who is actively receiving treatment for a hematologic or solid tumor malignancy
- Patient is not admitted to the transplant service
- Patient is able to read English or Spanish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
|
To compare the nutrition risk identification abilities of two nutrition screening tools: PEDSGA tool and the standard assessment tool.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the ability of two nutrition screening tools to identify nutritionally at risk patients
Time Frame: Within 90 days of study completion
|
Within 90 days of study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karen Smith, RD, MS, LDN, St. Jude Children's Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 22, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEDSGA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.