An observational study in Neoplasms and Palliative Care, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Observational
The goal of this observational study is to learn how symptom burden differs according to the level of diagnostic and therapeutic intensity agreed for each patient, in adults with cancer admitted to a palliative care unit. The main questions it aims to answer are:
Symptom control is the core of care in palliative care units, where most patients have advanced cancer and a high and complex symptom burden. Palliative care units also routinely assess the level of diagnostic and therapeutic intensity (NADT), a person-centred and dynamic classification of the degree of intervention aligned with each patient's goals of care. To our knowledge, the relationship between NADT and symptom burden has not been studied.
This prospective cross-sectional study will consecutively include adults with cancer admitted to the Palliative Care Unit of Hospital Residencia Sant Camil (Consorci Sanitari de l'Alt Penedès i Garraf) over 18 months. Within the first 72 hours of admission, two different healthcare professionals will assess: (1) symptom burden with the Spanish version of the ESAS, which rates the intensity of 9 symptoms from 0 (absent) to 10 (worst imaginable), following the recommendations of Centeno et al.; and (2) the NADT, which classifies patients into 5 levels. Sociodemographic and clinical variables, comorbidities, ECOG performance status, number of active medications, length of stay, and vital status at discharge will be collected from the medical record. Clinical decisions will follow usual practice and are not determined by the study.
For each NADT group, the mean total ESAS score and the percentage of patients with at least one clinically significant symptom will be estimated with 95% confidence intervals. Groups will be compared with ANOVA or the Kruskal-Wallis test, and multivariable models will adjust for potential confounders. A sample of 265 participants provides 80% power (alpha 0.05) to detect a 10-point difference in total ESAS score between three groups, allowing for an unequal distribution across groups.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 265 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients with an underlying cancer admitted to the Palliative Care Unit of Hospital Residencia Sant Camil during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive adult patients with an underlying cancer admitted to the Palliative Care Unit of Hospital Residencia Sant Camil during the study period.
Symptom burden (total ESAS score) by NADT group
Total score of the Edmonton Symptom Assessment System (ESAS), calculated as the sum of the intensity scores of 9 symptoms, each rated from 0 (absent) to 10 (worst imaginable). Total score range: 0 to 90; higher scores indicate greater symptom burden. Reported as mean with 95% CI for each NADT group.
Time frame: Within 72 hours of admission to the palliative care unit
Plan to share: Yes — IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Supporting information: Study protocol
Time frame: After publication of main results of the study.
Access criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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