Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT03035604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At 1 year', 'description': '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.'}, {'measure': 'Unplanned hospitalization rate', 'timeFrame': 'At 6 months and 1 year', 'description': '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.'}, {'measure': 'Hospital readmission rate', 'timeFrame': 'At 6 months', 'description': '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.'}, {'measure': 'Re-hospitalization rate', 'timeFrame': 'At 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nIII. 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.\n\nOUTLINE:\n\nParticipants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with hematologic and solid tumor cancers, undergo a comprehensive geriatric assessment by a geriatrician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With hematologic and solid tumor cancers.\n* Undergo a comprehensive geriatric assessment by a geriatrician.\n\nExclusion Criteria:\n\n* Unable or unwilling to sign consent form.\n* Life expectancy under 6 months.'}, 'identificationModule': {'nctId': 'NCT03035604', 'briefTitle': 'Comprehensive Nutritional Geriatric Assessments in Identifying Malnutrition in Older Cancer Participants', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Malnutrition in Older Cancer Patients', 'orgStudyIdInfo': {'id': '2016-0705'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01280', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-0705', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nutritional geriatric assessment', 'description': 'Participants undergo nutritional geriatric assessment over 15 minutes in person or on the phone every 3 months for 12 months.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment']}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment', 'type': 'OTHER', 'description': 'Undergo nutritional geriatric assessment', 'armGroupLabels': ['Nutritional geriatric assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Mehnaz Shafi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}