Clinical trial NCT06499623: Early Detection of Malnutrition in Oncology Patients and Elderly Patients
Official title: Early Detection of Malnutrition in Oncology Patients and People Over 65 Years of Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Keywords: malnutrition
oncology
gerontology
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: Brno University Hospital
name: Bulovka Hospital
name: Masaryk Memorial Cancer Institute
name: University Hospital, Motol
name: Hospital AGEL Nový Jičín a.s.
name: Military University Hospital, Prague
name: General University Hospital, Prague
name: University Hospital Olomouc
name: University Hospital Pilsen
First posted: 2024-07-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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+.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of people with malnutrition according to the PSNPO questionnaire
timeFrame: Until 31. 3. 2026
Secondary outcomes:
measure: Proportion of people with initiated nutritional intervention
timeFrame: Until 31. 3. 2026
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Nový Jičín
country: Czechia
facility: Hospital AGEL Nový Jičín a.s.
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Pilsen
country: Czechia
facility: University Hospital Pilsen
city: Prague
country: Czechia
facility: Bulovka Hospital
city: Prague
country: Czechia
facility: General University Hospital, Prague
city: Prague
country: Czechia
facility: Military University Hospital, Prague
city: Prague
country: Czechia
facility: University Hospital, Motol
Study officials:
affiliation: Charles University First Faculty of Medicine
name: Petra Beran Holeckova, MD
role: STUDY_DIRECTOR
References: