Evaluation of the Nutritional Status of Palliative Care Patients

NCT06753708 | Completed

• 1 other identifier: 16.09.2024/85
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the nutritional status of palliative care patients receiving enteral tube feeding. It aims to assess their condition using nutritional screening tools, anthropometric measurements and biochemical data to improve standards of care, patient safety and outcomes. The study will take place at a state hospital palliative care clinic from November 2024 to March 2025, with a possible extension to June 2025. Participants will be adults aged 18 years and older undergoing enteral tube feeding. Informed consent will be obtained, and data collection will include in-person interviews, patient questionnaires, food consumption records completed by family members, and biochemical data from medical records. Nutritional information will be analyzed using BeBIS software, and SPSS will be used for statistical analysis. The study aims to create effective nutrition plans, improve clinical protocols, and improve healthcare outcomes. By addressing gaps in the literature, particularly regarding enteral tube feeding in palliative care, this research will benefit patients, families, healthcare providers, and institutions. Anticipated benefits include improved patient care, reduced complications, shorter hospital stays, and cost savings to the healthcare system.

Conditions

Palliative Care; Tube Feeding

Keywords

Palliative Care; Malnutrition; Nutritional Status; Tube Feeding

Outcome Measures

Primary Outcomes (7)

• Malnutrition Status - NRS-2002 Score

  The NRS-2002 tool will be used to evaluate the malnutrition risk of patients. This screening tool, developed by ESPEN in 2002, includes components for nutritional status and disease severity. The total score will be recorded based on the assessment conducted by the researcher. Unit of Measure: NRS-2002 score; \>3 indicates malnutrition.

  7 days after admission to the palliative care unit

• Body Mass Index (BMI)

  Calculated from weight (measured or estimated) and height (measured or estimated). Unit of Measure: kg/m²

  7 days after admission to the palliative care unit

• Upper Mid-Arm Circumference

  Measured using a flexible tape measure. Unit of Measure: cm

  7 days after admission to the palliative care unit

• Skinfold Thickness

  Measured at specified anatomical sites using a Saehan Medical Skinfold Caliper. Unit of Measure: Millimeters (mm)\]

  7 days after admission to the palliative care unit

• Enteral Nutrition Record

  For each patient, enteral nutrition method, type, total daily feeding hours and nutrition infusion rate will be recorded on the form. Interruptions in enteral nutrition due to medical, technical or patient-related reasons, duration of interruption and treatment changes will also be recorded. This information will be obtained from the patients' nutrition files after obtaining the necessary permissions. Target energy and protein levels will be calculated by the investigator for each patient.

  7 days after admission to the palliative care unit

• Food Consumption Record

  A 24-hour food consumption record will be obtained for patients with oral intake in addition to tube enteral nutrition.

  7 days after admission to the palliative care unit

• Nutritional Biomarker Index

  A composite nutritional biomarker index will be calculated based on laboratory findings that have been recorded in patients files in the last 7 days. The index will include hemoglobin, hematocrit, albumin, and prealbumin levels, combined using a weighted scoring system to reflect overall nutritional status. Unit of Measure: Composite score (unitless)

  7 days after admission to the palliative care unit

Secondary Outcomes (26)

• Phenotypic Criteria - Weight Loss

  7 days after admission to the palliative care unit

• Phenotypic Criteria - Body Mass Index (BMI)

  7 days after admission to the palliative care unit

• Phenotypic Criteria - Muscle Mass

  7 days after admission to the palliative care unit

• Etiologic Criteria - Food Intake

  7 days after admission to the palliative care unit

• Etiologic Criteria - Inflammatory Status

  7 days after admission to the palliative care unit

Study Arms (1)

Palliative Care Patients

Patients over 18 years of age who received inpatient treatment in the Palliative Care Clinic of a State Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Palliative Care patients from a State Hospital in Istanbul / Türkiye

You may qualify if:

• Being 18 years of age or older
• Being treated in the Palliative Care Clinic
• Being fed with one of the tube enteral nutrition methods (only enteral/enteral + oral/enteral)

You may not qualify if:

• Having any limb amputation
• Being hospitalized in the Palliative Care Clinic for less than 3 days
• Receiving parenteral nutrition support

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara University, Faculty of Health Sciences

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Zehra M Celik

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: November 25, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-12

Locations

TU (2)