Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00710632
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2008-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening to Predict Weight Loss in Patients With Cancer
Sponsor:
Queen's Medical Center
Organization:
Study Overview
Official Title:
Predicting Weight Loss in People With Cancer: Development of a Screening Tool
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment.
PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.
PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.
Detailed Description:
OBJECTIVES:
* To identify people with cancer who are at greatest risk of future weight loss by the development of a simple and practical screening tool.
* To estimate the reliability of the Appetite and Symptom Questionnaire (part 1).
* To develop a screening tool based on the ability of the optimal combination of items from the three measures (ASQ, MUST, CRP) to predict clinically significant weight loss over three months (part 2).
* To estimate the sensitivity and specificity at various cut-points of the developed screening tool in predicting clinically significant weight loss (\> 10% weight loss or between 5% and 10% weight loss with a BMI \< 20 kg/m\^2) over three months (part 2).
OUTLINE: This is a two-part study.
* Part 1: Patients are asked to complete the Appetite and Symptom Questionnaire (ASQ) on two occasions, one week apart.
* Part 2: Patients are screened at baseline for risk of malnutrition using the Malnutrition Universal Screening Tool. Blood samples are also taken at this time to establish the level of C-reactive protein and patients complete the ASQ. Patients are weighed using calibrated scales and height measurements are obtained. Patients are asked about unplanned weight loss over the previous 3-6 months. Patients are weighed again at 3 months. Percentage weight loss is calculated at 3 months.
* To identify people with cancer who are at greatest risk of future weight loss by the development of a simple and practical screening tool.
* To estimate the reliability of the Appetite and Symptom Questionnaire (part 1).
* To develop a screening tool based on the ability of the optimal combination of items from the three measures (ASQ, MUST, CRP) to predict clinically significant weight loss over three months (part 2).
* To estimate the sensitivity and specificity at various cut-points of the developed screening tool in predicting clinically significant weight loss (\> 10% weight loss or between 5% and 10% weight loss with a BMI \< 20 kg/m\^2) over three months (part 2).
OUTLINE: This is a two-part study.
* Part 1: Patients are asked to complete the Appetite and Symptom Questionnaire (ASQ) on two occasions, one week apart.
* Part 2: Patients are screened at baseline for risk of malnutrition using the Malnutrition Universal Screening Tool. Blood samples are also taken at this time to establish the level of C-reactive protein and patients complete the ASQ. Patients are weighed using calibrated scales and height measurements are obtained. Patients are asked about unplanned weight loss over the previous 3-6 months. Patients are weighed again at 3 months. Percentage weight loss is calculated at 3 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: