Validation of a Nutrition Screening Tool

NCT01851928 | Completed DMC

• 1 other identifier: CCR 3621
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Screening Tool

  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.

  24 hrs

Secondary Outcomes (1)

• Specificity of the Tool

  24 hrs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, London .., SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Fallopian Tube Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Sarcoma; Vaginal Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Fallopian Tube Diseases; Adnexal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Vaginal Diseases; Vulvar Diseases

Study Officials

• Clare Shaw, Phd

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 13, 2013
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

GB (1)