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Clinical Trials/NCT03035604
NCT03035604
Active, Not Recruiting
N/A

Malnutrition in Older Cancer Patients

M.D. Anderson Cancer Center1 site in 1 country180 target enrollmentJanuary 24, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Sponsor
M.D. Anderson Cancer Center
Enrollment
180
Locations
1
Primary Endpoint
Mortality
Status
Active, Not Recruiting
Last Updated
5 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2017
End Date
June 30, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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