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Trial record 24 of 33 for:    Vagina Sarcoma

Validation of a Nutrition Screening Tool

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ClinicalTrials.gov Identifier: NCT01851928
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:

The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input.

The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.


Condition or disease
Adenocarcinoma of the Gastroesophageal Junction Cervical Cancer Endometrial Cancer Esophageal Cancer Fallopian Tube Cancer Gastric Cancer Ovarian Cancer Sarcoma Vaginal Cancer Vulvar Cancer

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Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Validation of Two Inpatient Adult Nutrition Screening Tools in Cancer Care - a Prospective Study
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 2013





Primary Outcome Measures :
  1. Sensitivity of Screening Tool [ Time Frame: 24 hrs ]
    The primary endpoint of the study is the sensitivity of each screening tool as compared to the gold standard of PG-SGA when completed by a trained dietitian.


Secondary Outcome Measures :
  1. Specificity of the Tool [ Time Frame: 24 hrs ]

    Secondary endpoints are as follows:

    • specificity of the screening tool
    • proportion of inpatients with malnutrition on admission



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be approached for consideration and recruitment to the study in a stratified manner in order to proportionately represent the diagnostic groups admitted to The Royal Marsden NHS Foundation Trust as inpatients. Patients will be approached sequentially from the list until the required number of patients are recruited for that particular diagnoses. Recruitment for particular diagnostic groups may take place over a number of days until the required number of patients is recruited. The same procedure will be repeated, with a newly generated list, for all selected diagnostic groups in a random order. This methodology will aim to capture patients who have been newly diagnosed, patients with established disease, patients newly admitted and those who have been inpatients for anumber of days or weeks.
Criteria

Inclusion Criteria:

  • All adult inpatients, over the age of 18, admitted to RMH for whom a measured weight and height can be obtained

Exclusion Criteria

  • Patients for whom it is not possible to obtain a measured height and weight
  • People with a definitive diagnosis of dementia
  • People who lack capacity to understand the purpose of the study and to consent
  • Patients who are unable to understand and speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851928


Locations
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United Kingdom
Royal Marsden Hospital NHS Foundation Trust
London, London .., United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Clare Shaw, Phd Royal Marsden Hospital NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01851928     History of Changes
Other Study ID Numbers: CCR 3621
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Vaginal Neoplasms
Vaginal Diseases
Endometrial Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Fallopian Tube Diseases
Vulvar Diseases