Integrated Bedside Assessment and Prognosis in Hospitalized Patients With Metastatic Cancer (PRO-HAND)

June 28, 2026 updated by: Galip Can Uyar, Ankara Etlik City Hospital

Integrated Assessment of Cachexia, Body Composition, and Patient-Reported Outcomes in Unplanned Hospitalizations of Metastatic Cancer Patients: The PRO-HAND Study

This prospective observational cohort study aims to evaluate whether integrated bedside assessment of handgrip strength, cachexia-related indices, body composition, and patient-reported outcomes improves short-term prognostic stratification in hospitalized patients with metastatic cancer. Handgrip strength is a simple, rapid, and non-invasive measure of muscle function and physical reserve, and it is increasingly recognized as an indicator of frailty, sarcopenia, nutritional status, and cancer cachexia. In addition to handgrip strength, this study evaluates the prognostic value of the handgrip strength-cachexia index, bioelectrical impedance analysis-derived body composition parameters, the CRP-triglyceride-glucose index, and validated patient-reported outcome measures. The study will examine whether these admission-time assessments are associated with 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Handgrip strength declines with age and is associated with frailty, sarcopenia, cancer cachexia, nutritional deterioration, and adverse clinical outcomes in patients with cancer. In this prospective observational cohort study, consecutive adult patients with histologically or cytologically confirmed metastatic solid malignancies undergoing unplanned hospitalization will be assessed at the time of admission. Handgrip strength will be measured within the first 48 hours of admission using a calibrated hydraulic hand dynamometer. Measurements will be performed on the dominant hand, with patients seated, the elbow flexed at 90 degrees, and the wrist in a neutral position, according to standardized procedures. Three consecutive measurements will be obtained, and the highest value will be recorded for analysis.

In addition to handgrip strength, admission-time assessments will include routine laboratory parameters, the handgrip strength-cachexia index, the CRP-triglyceride-glucose index, bioelectrical impedance analysis-derived body composition measures, and validated patient-reported outcome instruments, including SARC-F, FACT-G, PSQI, PG-SGA, visual analogue scale pain score, and visual analogue scale appetite score. Patients will be followed for short-term clinical outcomes, including 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission after index discharge.

Study Type

Observational

Enrollment (Actual)

233

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06210
        • Etlik City Hospital, Medical Oncology Department

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

The study population consists of adult patients aged 18 years and older with pathologically confirmed cancer who are admitted to the Ankara Etlik City Hospital, Department of Medical Oncology. Eligible participants are hospitalized for more than 48 hours and undergo hand grip strength measurement within 24 hours of admission. Patients represent a heterogeneous group of solid tumor cases across different cancer types and stages, reflecting a real-world hospitalized oncology population.

Description

Inclusion Criteria:

  • Adults aged 18 years and older
  • Pathologically confirmed diagnosis of cancer
  • Hospitalized with an expected hospital stay of more than 48 hours
  • Ability to provide written informed consent

Exclusion Criteria:

  • Diagnosis of anorexia nervosa
  • Acute pancreatitis or acute liver failure at admission
  • History of gastric bypass surgery
  • Presence of chronic active infections
  • History of solid organ transplantation
  • Pregnant or breastfeeding women

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
Hospitalized Cancer Patients
This cohort consists of adult patients (aged 18-80 years) with pathologically confirmed cancer who are admitted to the hospital for at least 48 hours. Hand grip strength is measured within the first 24 hours of admission using a standardized dynamometer protocol. Patients are followed prospectively for 30 days to evaluate primary and secondary outcomes including all-cause mortality, functional decline, hospital stay duration, readmission, and major complications.
Other: Hand Grip Strength Measurement
Hand grip strength will be measured within the first 24 hours of hospitalization using a calibrated hand dynamometer. Measurements will be performed on the dominant hand, with patients seated, following standardized international procedures. Three consecutive measurements will be obtained, and the average value will be recorded. The test is non-invasive, quick, and performed by oncology clinicians trained in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day All-Cause Mortality
Time Frame: 30 days after hospital admission
All-cause mortality within 30 days of hospital admission among cancer patients (Yes/No). Mortality status will be assessed through hospital records and follow-up. Hand grip strength values will be analyzed in relation to mortality risk.
30 days after hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive Care Unit Admission
Time Frame: 30 days after hospital admission
Number of patients requiring ICU admission within 30 days of hospital admission (Yes/No).
30 days after hospital admission
Hospital Readmission
Time Frame: 30 days after discharge
All-cause hospital readmission within 30 days of discharge (Yes/No).
30 days after discharge
Functional Decline - ECOG Performance Status
Time Frame: Baseline and 30 days after hospital admission
Decline in functional status assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status (range 0-4; 0 = fully active, 1 = restricted in strenuous activity, 2 = ambulatory but unable to work, 3 = limited self-care, 4 = completely disabled; higher score = worse performance), comparing baseline and 30-day follow-up.
Baseline and 30 days after hospital admission
Length of Hospital Stay
Time Frame: Through initial hospitalization, up to 30 days
Duration of initial hospitalization, measured in days from admission to discharge.
Through initial hospitalization, up to 30 days
Major Complications
Time Frame: 30 days after hospital admission
Incidence of major complications including hospital-acquired infection, respiratory failure, cardiovascular events, acute renal failure, or gastrointestinal failure within 30 days (Yes/No).
30 days after hospital admission
Functional Decline - Patient-Generated Subjective Global Assessment (PG-SGA)
Time Frame: Baseline and 30 days after hospital admission
Decline in nutritional status assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) Score (range 0-35; 0-1 = no intervention required, 2-3 = patient/family education, 4-8 = requires dietitian intervention, ≥9 = critical need for nutritional intervention and/or symptom management; higher score = worse nutritional status), comparing baseline and 30-day follow-up.
Baseline and 30 days after hospital admission

Collaborators and Investigators

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

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: Galip Can Uyar, MD, Ankara Etlik City Hospital

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)

September 1, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

August 23, 2025

First Submitted That Met QC Criteria

September 3, 2025

First Posted (Actual)

September 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-BADEK-2024-1105 (Other Identifier: Ankara Etlik City Hospital Ethics Committee)

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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