跳至主要内容
临床试验/NCT03035604
NCT03035604进行中(未招募)不适用

Malnutrition in Older Cancer Patients

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
2
主要终点
Mortality

研究概览

简要总结

This trial studies how well comprehensive nutritional geriatric assessments work in identifying malnutrition in older cancer participants. Comprehensive nutritional geriatric assessments may help doctors learn about ways to check for malnutrition (loss of weight/appetite that may result in health problems) that is due to cancer or cancer treatment.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate whether nutritional status, as determined by each of 4 screening tools (Mini Nutritional Assessment [MNA], weight loss, body mass index [BMI], and lean muscle mass), correlates with 6-month and 12-month mortality in older cancer patients after geriatric assessment, after adjusting for covariates.

II. To evaluate whether nutritional status, as determined by each of by 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month unplanned hospitalization in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

III. To evaluate whether nutritional status, as determined by each of 4 screening tools (MNA, weight loss, BMI, and lean muscle mass) correlates with 6-month and 12-month hospital readmissions in older cancer patients who undergo geriatric assessment, after adjusting for covariates.

OUTLINE:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • With hematologic and solid tumor cancers.
  • Undergo a comprehensive geriatric assessment by a geriatrician.

排除标准

  • Unable or unwilling to sign consent form.
  • Life expectancy under 6 months.

结局指标

主要结局

Mortality

时间窗: At 6 months

The association between nutrition status and mortality (6-month and 1-year mortality since geriatric assessment) will be assessed by logistic regression analysis, considering mortality as a response variable. Univariate logistic regression analysis will be used to estimate the crude odds ratio, and multivariable logistic regression will be used to estimate the adjusted odds ratio, after controlling for potential confounder variables, such as age, race, cancer type, cancer stage, co-morbidity, cognitive status), and frailty. ROC curve to predict 6-month and 1-year mortality will be constructed for nutritional status, as determined by each screening tool. The area under the ROC curve, sensitivity, and specificity and 95% confidence intervals will be obtained for each screening tool.

次要结局

  • Mortality(At 1 year)
  • Unplanned hospitalization rate(At 6 months and 1 year)
  • Hospital readmission rate(At 6 months)
  • Re-hospitalization rate(At 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Comprehensive Nutritional Geriatric Assessments in... | 临床试验