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Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00665691
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date April 22, 2008
First Posted Date April 24, 2008
Last Update Posted Date April 26, 2017
Study Start Date September 2003
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2008)
To compare the ability of two nutrition screening tools to identify nutritionally at risk patients [ Time Frame: Within 90 days of study completion ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
Official Title Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
Brief Summary 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.
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
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Compare Two Nutrition Screening Tools
Intervention Other: Nutritional Screening Tools
To compare the nutrition risk identification abilities of two nutrition screening tools: PEDSGA tool and the standard assessment tool.
Study Groups/Cohorts 1
Intervention: Other: Nutritional Screening Tools
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2008)
132
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00665691
Other Study ID Numbers PEDSGA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor St. Jude Children's Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Karen Smith, RD, MS, LDN St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date June 2011