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Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants

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ClinicalTrials.gov Identifier: NCT03035604
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Malnutrition Solid Neoplasm Other: Comprehensive Geriatric Assessment

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.


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Study Type : Observational
Estimated Enrollment : 284 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition in Older Cancer Patients
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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.
Other: Comprehensive Geriatric Assessment
Undergo nutritional geriatric assessment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with hematologic and solid tumor cancers, undergo a comprehensive geriatric assessment by a geriatrician
Criteria

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.

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): NCT03035604


Contacts
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Contact: John R. Stroehlein, MD 713-794-5073 jrstroeh@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: John R. Stroehlein    713-794-5073      
Principal Investigator: John R. Stroehlein         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John R Stroehlein M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03035604     History of Changes
Other Study ID Numbers: 2016-0705
NCI-2018-01280 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0705 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hematologic Neoplasms
Malnutrition
Neoplasms
Nutrition Disorders
Neoplasms by Site
Hematologic Diseases