- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035604
Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants
Malnutrition in Older Cancer Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
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:
Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mehnaz A. Shafi, MD
- Phone Number: (713) 794-5073
- Email: mashafi@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- With hematologic and solid tumor cancers.
- Undergo a comprehensive geriatric assessment by a geriatrician.
Exclusion Criteria:
- Unable or unwilling to sign consent form.
- Life expectancy under 6 months.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nutritional geriatric assessment
Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.
|
Undergo nutritional geriatric assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 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.
|
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: At 1 year
|
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.
|
At 1 year
|
Unplanned hospitalization rate
Time Frame: At 6 months and 1 year
|
The associations between nutrition status and unplanned hospitalization will be assessed by logistic regression analysis.
Univariate logistic regression analysis will be used to get the crude odds ratio, and multivariable logistic regression will be used to get the adjusted odds ratio, after controlling for potential confounder variables, such as age, race, cancer type, cancer stage, co-morbidity, cognitive status, and frailty.
Patients who died before 6 months or 1 year from geriatric test will be considered as having unplanned 6-month or 1-year hospitalization.
ROC curve to predict each of secondary outcomes 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.
Descriptive statistics will be used to summarize data.
Two sample t-test or Wilcoxon rank-sum test will be used for the comparison in numeric variables.
|
At 6 months and 1 year
|
Hospital readmission rate
Time Frame: At 6 months
|
The associations between nutrition status and hospital readmissions will be assessed by logistic regression analysis.
Univariate logistic regression analysis will be used to get the crude odds ratio, and multivariable logistic regression will be used to get the adjusted odds ratio, after controlling for potential confounder variables, such as age, race, cancer type, cancer stage, co-morbidity, cognitive status, and frailty.
Patients who died before 6 months or 1 year from geriatric test will be considered as having unplanned 6-month or 1-year hospitalization.
ROC curve to predict each of secondary outcomes 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.
Descriptive statistics will be used to summarize data.
Two sample t-test or Wilcoxon rank-sum test will be used for the comparison in numeric variables.
|
At 6 months
|
Re-hospitalization rate
Time Frame: At 1 year
|
The associations between nutrition status and hospital readmissions will be assessed by logistic regression analysis.
Univariate logistic regression analysis will be used to get the crude odds ratio, and multivariable logistic regression will be used to get the adjusted odds ratio, after controlling for potential confounder variables, such as age, race, cancer type, cancer stage, co-morbidity, cognitive status, and frailty.
Patients who died before 6 months or 1 year from geriatric test will be considered as having unplanned 6-month or 1-year hospitalization.
ROC curve to predict each of secondary outcomes 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.
Descriptive statistics will be used to summarize data.
Two sample t-test or Wilcoxon rank-sum test will be used for the comparison in numeric variables.
|
At 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehnaz Shafi, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0705 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01280 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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