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Uitgebreide nutritionele geriatrische beoordelingen bij het identificeren van ondervoeding bij oudere deelnemers aan kanker

6 november 2026 bijgewerkt door: M.D. Anderson Cancer Center

Ondervoeding bij oudere kankerpatiënten

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

180

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • M D Anderson Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Nutritional geriatric assessment

Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.
Ander: Comprehensive Geriatric Assessment

Undergo nutritional geriatric assessment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mortality
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mortality
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

M.D. Anderson Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Mehnaz Shafi, M.D. Anderson Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 januari 2017

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

24 januari 2017

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2017

Eerst geplaatst (Geschat)

30 januari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2016-0705
  • 2016-0705 (Andere identificatie: M D Anderson Cancer Center)
  • NCI-2018-01280 (Register-ID: CTRP (Clinical Trial Reporting Program))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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