Early Detection of Malnutrition in Oncology Patients and Elderly Patients (MALNUTRITION)

October 1, 2024 updated by: Institute of Health Information and Statistics of the Czech Republic

Early Detection of Malnutrition in Oncology Patients and People Over 65 Years of Age

The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.

The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

Another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. This process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life.

The project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000282.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 60200
        • Enrolling by invitation
        • Brno University Hospital
      • Brno, Czechia, 60200
        • Recruiting
        • Masaryk Memorial Cancer Institute
        • Contact:
        • Principal Investigator:
          • Věra Andrášková, MSc
        • Principal Investigator:
          • Andrea Jurečková, MD
      • Nový Jičín, Czechia
        • Recruiting
        • Hospital AGEL Nový Jičín a.s.
        • Contact:
        • Principal Investigator:
          • Viktor Maňásek, MD
      • Olomouc, Czechia
        • Enrolling by invitation
        • University Hospital Olomouc
      • Pilsen, Czechia
        • Enrolling by invitation
        • University Hospital Pilsen
      • Prague, Czechia
        • Recruiting
        • University Hospital, Motol
        • Contact:
        • Principal Investigator:
          • Milan Kvapil, Prof.
      • Prague, Czechia
        • Recruiting
        • Bulovka Hospital
        • Contact:
        • Principal Investigator:
          • Petra Holečková, MD
      • Prague, Czechia
        • Enrolling by invitation
        • General University Hospital, Prague
      • Prague, Czechia
        • Recruiting
        • Military University Hospital, Prague
        • Contact:
        • Principal Investigator:
          • Denisa Janíčková Ždárská, Assoc. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with oncological diagnosis with age 18+ or patients with hospitalization at least 14 days and age 65+.

Description

Inclusion Criteria:

Cohort Oncological patients:

  • 18+
  • an oncological diagnosis
  • a survival prognosis of at least 3 months

Cohort Patients older than 65 years:

  • 65+
  • hospitalization at least 14 days or longer

Exclusion Criteria (both cohorts):

  • not agreeing to participate in the project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oncological patients
The inclusion criteria for the cohort of oncological patients are age 18+, an oncological diagnosis and a survival prognosis of at least 3 months.
Diagnostic test: Blood test
Albumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D
Diagnostic test: Bioelectrical Impedance Analysis
Total Impedance, Segmental Muscle Analysis, Segmental Fat Analysis, Absolute Muscle Mass Value, Muscle Mass Index, Total Body Fat Percentage, Total Body Water, Phase Angle Measurement
Other: Nutritional Risk Assessment Questionnaire
Fill in the Questionnaire of the Working Group on Nutritional Care in Oncology and get nutrition risk score. The objective data includes weight loss in 6 months, current BMI and food tolerance, and oncological diagnosis including ongoing anti-cancer treatment.
Patients older than 65 years
The inclusion criteria for this cohort are age 65 and older and hospitalization at least 14 days or longer.
Diagnostic test: Blood test
Albumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D
Diagnostic test: Bioelectrical Impedance Analysis
Total Impedance, Segmental Muscle Analysis, Segmental Fat Analysis, Absolute Muscle Mass Value, Muscle Mass Index, Total Body Fat Percentage, Total Body Water, Phase Angle Measurement
Other: Nutritional Risk Assessment Questionnaire
Fill in the Questionnaire of the Working Group on Nutritional Care in Oncology and get nutrition risk score. The objective data includes weight loss in 6 months, current BMI and food tolerance, and oncological diagnosis including ongoing anti-cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of people with malnutrition according to the PSNPO questionnaire
Time Frame: Until 31. 3. 2026
Until 31. 3. 2026

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of people with initiated nutritional intervention
Time Frame: Until 31. 3. 2026
Until 31. 3. 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

Brno University Hospital
University Hospital Olomouc
University Hospital Pilsen
General University Hospital, Prague
Masaryk Memorial Cancer Institute
University Hospital, Motol
Military University Hospital, Prague
Bulovka Hospital
Hospital AGEL Nový Jičín a.s.

Investigators

  • Study Director: Petra Beran Holeckova, MD, Charles University First Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZIS 2024/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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