CancerPRO-HANDNCT07167082
Multidomain Bedside Assessment of Short-Term Mortality and Readmission in Hospitalized Patients With Metastatic Cancer
An observational study of Cancer and Hospitalizations, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated whether simple bedside assessments performed during an unplanned hospitalization were associated with short-term outcomes in adults with metastatic solid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hospitalizations, Sarcopenia
- What is being tested?
- Handgrip Strength Assessment
- How many people
- 233 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 13 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer who underwent unplanned admission to the medical oncology inpatient unit of Ankara Etlik City Hospital. Consecutive eligible patients were enrolled during the recruitment period. Bedside assessments, including handgrip strength, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment, were performed within the first 48 hours of index hospitalization.
Who may be able to join
- Age 18 years or older
- Histologically or cytologically confirmed metastatic solid cancer
- Unplanned admission to the medical oncology inpatient unit
- Ability and willingness to provide written informed consent
Who cannot join
- Receiving curative-intent treatment without distant metastatic disease
- Estimated life expectancy of less than 48 hours at the time of admission, as judged by the treating oncologist
- Unable or unwilling to provide written informed consent
- Impaired consciousness or inability to cooperate with bedside assessments
- Contraindication to bioelectrical impedance analysis according to the study protocol, including implanted cardiac electronic devices or metallic implants that precluded bioelectrical impedance assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, 06210
About this study
Official title: Multidomain Bedside Assessment of Short-Term Mortality and Readmission Following Unplanned Hospitalization in Patients With Metastatic Cancer: The PRO-HAND Study
This prospective observational study evaluated whether simple bedside assessments performed during an unplanned hospitalization were associated with short-term outcomes in adults with metastatic solid cancer. The assessments included handgrip strength, blood-based cachexia and inflammatory-metabolic indices, body composition measured by bioelectrical impedance analysis, and patient-reported and nutritional measures.
The primary outcome was death from any cause within 30 days of the index hospital admission. Additional outcomes were death from any cause within 90 days and the first unplanned hospital readmission within 30 days after live discharge. The study aimed to determine whether different bedside domains were associated with mortality and readmission and whether these associations differed across outcomes.
Participants received usual clinical care, and no treatment was assigned by the study.
Read the detailed description
This prospective observational cohort study was conducted in the medical oncology inpatient unit of Ankara Etlik City Hospital. Consecutive adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer undergoing unplanned hospitalization were assessed for eligibility.
Study assessments were performed during the index hospitalization. Laboratory values used to calculate composite indices were obtained within the first 24 hours of admission. Handgrip strength testing, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment were performed within the first 48 hours of admission and, whenever clinically feasible, before initiation of new inpatient therapeutic interventions.
Handgrip strength was measured using a calibrated hydraulic hand dynamometer with the patient seated, the elbow flexed at 90 degrees, and the wrist in a neutral position. Three measurements of the dominant hand were obtained at 60-second intervals, and the highest value was retained for analysis.
The two primary composite bedside exposures were the handgrip strength-cachexia index and the standardized C-reactive protein-triglyceride-glucose index. Body-composition measures obtained by bioelectrical impedance analysis included phase angle, fat-free mass, fat mass, skeletal muscle mass, and total body water. Patient-reported and nutritional assessments included the Functional Assessment of Cancer Therapy-General, the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls questionnaire, the Pittsburgh Sleep Quality Index, resting pain assessed using a visual analog scale, appetite impairment assessed using a visual analog scale, and the Patient-Generated Subjective Global Assessment.
The primary outcome was 30-day all-cause mortality measured from the date of index admission. Additional outcomes were 90-day all-cause mortality and the first unplanned inpatient readmission within 30 days after live discharge. Planned admissions for anticancer treatment, scheduled procedures, day-case therapy, emergency department visits without inpatient admission, and observation stays were not counted as unplanned readmissions.
The study evaluated whether cachexia-related, inflammatory-metabolic, body-composition, patient-reported, and nutritional bedside measures were associated with short-term mortality and unplanned readmission. The study was observational and did not assign or modify anticancer or supportive treatment.
- Conditions
- Cancer, Hospitalizations, Sarcopenia, Cachexia; Cancer; Sarcopenia
- Being tested
- Handgrip Strength Assessment
- Keywords
- Hand Grip Strength, Prognosis, Hospitalized Cancer Patients, Cachexia, Malnutrition, Functional Decline, Mortality
- Medical subject headings
- Neoplasms, Sarcopenia, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip Strength AssessmentOther
Handgrip strength was measured within the first 48 hours of the index hospitalization using a calibrated hydraulic hand dynamometer. Measurements were performed on the dominant hand with the patient seated, the elbow flexed at 90 degrees, and the wrist in a neutral position. Three measurements were obtained at 60-second intervals, and the highest value was retained for analysis. Measurement was deferred when acute injury or recent surgery involved the dominant upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients With Metastatic Solid Cancer | This cohort consisted of adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer undergoing unplanned hospitalization in the medical oncology inpatient unit. Bedside assessments, including handgrip strength, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment, were performed within the first 48 hours of the index hospitalization. Participants were followed for 30-day all-cause mortality, 90-day all-cause mortality, and the first unplanned hospital readmission within 30 days after live discharge. Receives: Other: Handgrip Strength Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day All-Cause Mortality
All-cause mortality within 30 days of the index hospital admission. Mortality was assessed from the date of index admission using hospital records and structured follow-up. All enrolled participants were included in this outcome assessment.
Measured: 30 days after index hospital admission
Secondary outcomes (2)
90-Day All-Cause Mortality
All-cause mortality within 90 days of the index hospital admission. Mortality was assessed from the date of index admission using hospital records and structured follow-up. All enrolled participants were included in this outcome assessment.
Measured: 90 days after index hospital admission
30-Day Unplanned Hospital Readmission After Live Discharge
The first unplanned inpatient hospital readmission occurring within 30 days after live discharge from the index hospitalization. Emergency department visits or observation stays without inpatient admission and planned admissions for systemic anticancer treatment, day-case therapy, scheduled procedures, or other elective care were not considered unplanned readmissions. This outcome was evaluated among participants discharged alive from the index hospitalization.
Measured: 30 days after live discharge from index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Dec 2024
- Primary completion14 Nov 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167082
- Sponsor's protocol ID
- AEŞH-BADEK-2024-1105
- Other IDs
- AEŞH-BADEK-2024-1105
- Acronym
- PRO-HAND
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidomain Bedside Assessment of Short-Term Mortality and Readmission Following Unplanned Hospitalization in Patients With Metastatic Cancer: The PRO-HAND Study
- ClinicalTrials.gov ID
- NCT07167082
- Acronym / sponsor ID
- PRO-HAND / AEŞH-BADEK-2024-1105
- Conditions
- Cancer, Hospitalizations, Sarcopenia, Cachexia; Cancer; Sarcopenia
- Keywords
- Hand Grip Strength, Prognosis, Hospitalized Cancer Patients, Cachexia, Malnutrition, Functional Decline, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study evaluated whether simple bedside assessments performed during an unplanned hospitalization were associated with short-term outcomes in adults with metastatic solid cancer. The assessments included handgrip strength, blood-based cachexia and inflammatory-metabolic indices, body composition measured by bioelectrical impedance analysis, and patient-reported and nutritional measures.
The primary outcome was death from any cause within 30 days of the index hospital admission. Additional outcomes were death from any cause within 90 days and the first unplanned hospital readmission within 30 days after live discharge. The study aimed to determine whether different bedside domains were associated with mortality and readmission and whether these associations differed across outcomes.
Participants received usual clinical care, and no treatment was assigned by the study.
Detailed description
This prospective observational cohort study was conducted in the medical oncology inpatient unit of Ankara Etlik City Hospital. Consecutive adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer undergoing unplanned hospitalization were assessed for eligibility.
Study assessments were performed during the index hospitalization. Laboratory values used to calculate composite indices were obtained within the first 24 hours of admission. Handgrip strength testing, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment were performed within the first 48 hours of admission and, whenever clinically feasible, before initiation of new inpatient therapeutic interventions.
Handgrip strength was measured using a calibrated hydraulic hand dynamometer with the patient seated, the elbow flexed at 90 degrees, and the wrist in a neutral position. Three measurements of the dominant hand were obtained at 60-second intervals, and the highest value was retained for analysis.
The two primary composite bedside exposures were the handgrip strength-cachexia index and the standardized C-reactive protein-triglyceride-glucose index. Body-composition measures obtained by bioelectrical impedance analysis included phase angle, fat-free mass, fat mass, skeletal muscle mass, and total body water. Patient-reported and nutritional assessments included the Functional Assessment of Cancer Therapy-General, the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls questionnaire, the Pittsburgh Sleep Quality Index, resting pain assessed using a visual analog scale, appetite impairment assessed using a visual analog scale, and the Patient-Generated Subjective Global Assessment.
The primary outcome was 30-day all-cause mortality measured from the date of index admission. Additional outcomes were 90-day all-cause mortality and the first unplanned inpatient readmission within 30 days after live discharge. Planned admissions for anticancer treatment, scheduled procedures, day-case therapy, emergency department visits without inpatient admission, and observation stays were not counted as unplanned readmissions.
The study evaluated whether cachexia-related, inflammatory-metabolic, body-composition, patient-reported, and nutritional bedside measures were associated with short-term mortality and unplanned readmission. The study was observational and did not assign or modify anticancer or supportive treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients With Metastatic Solid Cancer | – | Other: Handgrip Strength AssessmentThis cohort consisted of adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer undergoing unplanned hospitalization in the medical oncology inpatient unit. Bedside assessments, including handgrip strength, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment, were performed within the first 48 hours of the index hospitalization. Participants were followed for 30-day all-cause mortality, 90-day all-cause mortality, and the first unplanned hospital readmission within 30 days after live discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18 years or older with histologically or cytologically confirmed metastatic solid cancer who underwent unplanned admission to the medical oncology inpatient unit of Ankara Etlik City Hospital. Consecutive eligible patients were enrolled during the recruitment period. Bedside assessments, including handgrip strength, bioelectrical impedance analysis, patient-reported measures, and nutritional assessment, were performed within the first 48 hours of index hospitalization.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Histologically or cytologically confirmed metastatic solid cancer
- Unplanned admission to the medical oncology inpatient unit
- Ability and willingness to provide written informed consent
Key exclusion criteria (5 listed)
- Receiving curative-intent treatment without distant metastatic disease
- Estimated life expectancy of less than 48 hours at the time of admission, as judged by the treating oncologist
- Unable or unwilling to provide written informed consent
- Impaired consciousness or inability to cooperate with bedside assessments
- Contraindication to bioelectrical impedance analysis according to the study protocol, including implanted cardiac electronic devices or metallic implants that precluded bioelectrical impedance assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip Strength AssessmentHandgrip strength was measured within the first 48 hours of the index hospitalization using a calibrated hydraulic hand dynamometer. Measurements were performed on the dominant hand with the patient seated, the elbow flexed at 90 degrees, and the wrist in a neutral position. Three measurements were obtained at 60-second intervals, and the highest value was retained for analysis. Measurement was deferred when acute injury or recent surgery involved the dominant upper extremity. | Other | Hospitalized Patients With Metastatic Solid Cancer |
Primary outcome
30-day All-Cause Mortality
Time frame: 30 days after index hospital admission
All-cause mortality within 30 days of the index hospital admission. Mortality was assessed from the date of index admission using hospital records and structured follow-up. All enrolled participants were included in this outcome assessment.
2 secondary outcomes
90-Day All-Cause Mortality
Time frame: 90 days after index hospital admission
30-Day Unplanned Hospital Readmission After Live Discharge
Time frame: 30 days after live discharge from index hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galip Can Uyar, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hospitalizations, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day All-Cause Mortality (time frame: 30 days after index hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.