Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants

NCT03035604 | Active Not Recruiting

• 2 other identifiers: 2016-0705NCI-2018-01280
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Mortality

  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 Outcomes (4)

• 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 Arms (1)

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

Interventions

Comprehensive Geriatric Assessment OTHER

Undergo nutritional geriatric assessment

Nutritional geriatric assessment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with hematologic and solid tumor cancers, undergo a comprehensive geriatric assessment by a geriatrician

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Mehnaz Shafi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 30, 2017
• Study Start: January 24, 2017
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)