CancerNECPAL_HUILNCT07387224
Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care
An observational study of Cancer and Chronic Liver Disease (CLD), run by Infanta Leonor University Hospital at 2 sites in Spain.
Trial summary
Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Liver Disease (CLD), Heart Failure Chronic
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2024to 1 Feb 2028
- How long will I take part?
- 38 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 consists of adult patients with advanced oncological and non-oncological chronic diseases who are hospitalized for an acute medical condition or evaluated in a day hospital setting. Patients are consecutively assessed as part of routine clinical care and screened for palliative care needs using the NECPAL tool.
Who may be able to join
- Adults aged 18 years or older.
- Hospitalized patients admitted for an acute medical condition or patients attending a day hospital.
- Presence of at least one advanced chronic oncological or non-oncological disease.
- Ability to provide informed consent or availability of a legally authorized representative to provide consent.
Who cannot join
- Patients in the last days of life at the time of assessment.
- Patients who die during the acute hospitalization process.
- Patients with end-stage organ failure who are listed for organ transplantation.
- Patients with severe psychiatric disease that interferes with study participation.
- Patients previously included in the study during a prior hospital admission.
- Patients for whom outpatient follow-up cannot be ensured.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28023
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28030
About this study
Official title: Study to Identify Patients With Advanced Chronic Conditions in Need of Palliative Care: Validation of the NECPAL Instrument.
Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions.
This prospective observational study aims to identify hospitalized patients and patients attending a day hospital with advanced chronic conditions who have palliative care needs, using the NECPAL tool. NECPAL is a validated screening instrument designed to identify patients with advanced chronic diseases who may benefit from palliative care, based on clinical indicators, disease progression, functional decline, and health care utilization.
Read more
Adult patients with advanced oncological and non-oncological chronic diseases will be consecutively evaluated. The NECPAL tool will be applied by trained investigators as part of routine clinical assessment. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria.
The study will estimate the proportion of patients identified as NECPAL positive, describe their clinical characteristics, and analyze whether they are receiving palliative care. Secondary objectives include comparing clinical variables, comorbidity indices, and mortality between NECPAL-positive and NECPAL-negative patients over follow-up.
The results of this study will provide information on the prevalence of palliative care needs among patients with advanced chronic diseases and support early identification strategies in hospital settings.
Read the detailed description
This is a prospective, observational, analytical study designed to identify patients with advanced chronic conditions who have palliative care needs, using the NECPAL screening tool.
The study will be conducted in hospitalized patients admitted for an acute medical condition and in patients attending a day hospital. Adult patients with at least one advanced chronic oncological or non-oncological disease will be consecutively assessed during routine clinical care.
The NECPAL tool will be applied by trained investigators following the standardized methodology recommended by its developers. The assessment begins with the Surprise Question ("Would you be surprised if this patient died within the next 12 months?"). If the answer is negative, additional clinical indicators related to disease severity, functional decline, comorbidity, symptom burden, and health care utilization are evaluated. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria.
For patients identified as NECPAL positive, information regarding current palliative care involvement will be recorded. Clinical, functional, social, and health care utilization variables will be collected from the electronic medical record as part of routine clinical documentation.
Secondary analyses will compare NECPAL-positive and NECPAL-negative patients in terms of comorbidity, functional status, and mortality. Mortality will be assessed during follow-up using hospital records and, when necessary, telephone contact.
The study aims to describe the prevalence of palliative care needs in patients with advanced chronic diseases, evaluate the alignment between identified needs and current palliative care provision, and support early identification of patients who may benefit from palliative care in hospital settings.
- Conditions
- Cancer, Chronic Liver Disease (CLD), Heart Failure Chronic, Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- NECPAL tool, Palliative Care Needs, Advanced Chronic Conditions, Early Identification, Screening Tool, Observational Study, Prediction
- Medical subject headings
- Neoplasms, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Adult patients with advanced oncological and non-oncological chronic diseases hospitalized for an acute medical condition or attending a day hospital, assessed using the NECPAL screening tool as part of routine clinical care. No experimental intervention is assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Identified as NECPAL Positive
Proportion of adult patients with advanced oncological and non-oncological chronic diseases who are identified as NECPAL positive using the NECPAL screening tool during hospital admission or day hospital assessment.
Measured: At baseline (at the time of inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
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.
- 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
- 200 participants (actual)
- Target duration
- 38 Months
Sponsor and investigators
- Lead sponsor
- Infanta Leonor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Universitario del Sureste
- Responsible party
- Principal investigator, Anabel Franco Moreno, Infanta Leonor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387224
- Sponsor's protocol ID
- NECPAL_HU-Infanta Leonor
- Acronym
- NECPAL_HUIL
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the observational nature of the study and the inclusion of sensitive clinical data collected from routine care. Data sharing would require additional ethical approvals and data-sharing agreements that are not currently planned.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify Patients With Advanced Chronic Conditions in Need of Palliative Care: Validation of the NECPAL Instrument.
- ClinicalTrials.gov ID
- NCT07387224
- Acronym / sponsor ID
- NECPAL_HUIL / NECPAL_HU-Infanta Leonor
- Conditions
- Cancer, Chronic Liver Disease (CLD), Heart Failure Chronic, Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- NECPAL tool, Palliative Care Needs, Advanced Chronic Conditions, Early Identification, Screening Tool, Observational Study, Prediction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Infanta Leonor University HospitalUniversity, hospital or other
- Collaborators
- Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Universitario del Sureste
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 4 Feb 2026 (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.
Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions.
This prospective observational study aims to identify hospitalized patients and patients attending a day hospital with advanced chronic conditions who have palliative care needs, using the NECPAL tool. NECPAL is a validated screening instrument designed to identify patients with advanced chronic diseases who may benefit from palliative care, based on clinical indicators, disease progression, functional decline, and health care utilization.
Adult patients with advanced oncological and non-oncological chronic diseases will be consecutively evaluated. The NECPAL tool will be applied by trained investigators as part of routine clinical assessment. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria.
The study will estimate the proportion of patients identified as NECPAL positive, describe their clinical characteristics, and analyze whether they are receiving palliative care. Secondary objectives include comparing clinical variables, comorbidity indices, and mortality between NECPAL-positive and NECPAL-negative patients over follow-up.
The results of this study will provide information on the prevalence of palliative care needs among patients with advanced chronic diseases and support early identification strategies in hospital settings.
Detailed description
This is a prospective, observational, analytical study designed to identify patients with advanced chronic conditions who have palliative care needs, using the NECPAL screening tool.
The study will be conducted in hospitalized patients admitted for an acute medical condition and in patients attending a day hospital. Adult patients with at least one advanced chronic oncological or non-oncological disease will be consecutively assessed during routine clinical care.
The NECPAL tool will be applied by trained investigators following the standardized methodology recommended by its developers. The assessment begins with the Surprise Question ("Would you be surprised if this patient died within the next 12 months?"). If the answer is negative, additional clinical indicators related to disease severity, functional decline, comorbidity, symptom burden, and health care utilization are evaluated. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria.
For patients identified as NECPAL positive, information regarding current palliative care involvement will be recorded. Clinical, functional, social, and health care utilization variables will be collected from the electronic medical record as part of routine clinical documentation.
Secondary analyses will compare NECPAL-positive and NECPAL-negative patients in terms of comorbidity, functional status, and mortality. Mortality will be assessed during follow-up using hospital records and, when necessary, telephone contact.
The study aims to describe the prevalence of palliative care needs in patients with advanced chronic diseases, evaluate the alignment between identified needs and current palliative care provision, and support early identification of patients who may benefit from palliative care in hospital settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 38 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | –Adult patients with advanced oncological and non-oncological chronic diseases hospitalized for an acute medical condition or attending a day hospital, assessed using the NECPAL screening tool as part of routine clinical care. No experimental intervention is assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with advanced oncological and non-oncological chronic diseases who are hospitalized for an acute medical condition or evaluated in a day hospital setting. Patients are consecutively assessed as part of routine clinical care and screened for palliative care needs using the NECPAL tool.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Hospitalized patients admitted for an acute medical condition or patients attending a day hospital.
- Presence of at least one advanced chronic oncological or non-oncological disease.
- Ability to provide informed consent or availability of a legally authorized representative to provide consent.
Key exclusion criteria (6 listed)
- Patients in the last days of life at the time of assessment.
- Patients who die during the acute hospitalization process.
- Patients with end-stage organ failure who are listed for organ transplantation.
- Patients with severe psychiatric disease that interferes with study participation.
- Patients previously included in the study during a prior hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Identified as NECPAL Positive
Time frame: At baseline (at the time of inclusion)
Proportion of adult patients with advanced oncological and non-oncological chronic diseases who are identified as NECPAL positive using the NECPAL screening tool during hospital admission or day hospital assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the observational nature of the study and the inclusion of sensitive clinical data collected from routine care. Data sharing would require additional ethical approvals and data-sharing agreements that are not currently planned.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Chronic Liver Disease (CLD), run by Infanta Leonor University Hospital at 2 sites in Spain.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of Patients Identified as NECPAL Positive (time frame: At baseline (at the time of inclusion)). 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 10 Jun 2026.