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NCT Number: NCT03035604

Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Geriatric Assessment

Other

Undergo nutritional geriatric assessment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Malnutrition in Older Cancer Patients

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2017
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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