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Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases

Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06909968
Enrollment
178
Registered
2025-04-04
Start date
2020-12-14
Completion date
2025-10-17
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chronic Obstructive Pulmonary Disease, Chronic Renal Failure, Idiopathic Pulmonary Fibrosis

Keywords

palliative care, appropriateness, cancer, chronic pulmonary failure, chronic renal failure

Brief summary

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Detailed description

This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. The primary objective is to analyze appropriateness and timeliness of progressive palliative care approach (initially simultaneously with ongoing disease-oriented treatment and subsequently possibly as the only modality of care to avoid aggressiveness of care) in patients with: * First diagnosis of advanced metastatic non-small cell lung cancer, or advanced gastric cancer or advanced pancreatic adenocarcinoma * advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF). * advanced chronic renal failure

Interventions

OTHERpalliative care

As this study is intended to be observational (not interventional), the patient's medical record will be the source of all data to be recorded. No additional procedures/patient visits should be planned in the study with respect to clinical practice. Two tools will be used to to analyze appropriateness and timeliness of progressive palliative care approach: NECPAL CCOMS-ICO(©), specific for the assessment of needs in palliative care, and the PaP score, for the assessment of prognosis.

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Both sex; * All ethnic background; * Age ≥18 years; * Subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures; * Written informed consent; * Not receiving care from the palliative care service Inclusion Criteria specific for POPULATION A: * Diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded); * Life expectancy \>2 months; Inclusion Criteria specific for POPULATION B: * Diagnosis of chronic obstructive pulmonary disease (COPD) with at least two of these characteristics: age \> 70 years, FEV1 \<30 % predicted, oxygen-therapy dependency, \> 1 admission/year in hospital for COPD exacerbated, congestive heart failure and/or other comorbidity, weight loss/cachexia, reduced functional autonomy, increase dependence. * or idiopathic pulmonary fibrosis (IPF) diagnosis with at least two of these characteristics: age \> 70 years, histological pattern UIP (if known), dependence on oxygen-therapy, radiological aspect of Honeycomb to the HRTC of the thorax, reduced functional autonomy, increased dependence. Inclusion Criteria specific for POPULATION C: \- Diagnosis advanced chronic renal failure with at least two of these characteristics: age \> 75 years, advanced malignancy, severe malnutrition, cardiac or pulmonary pathology terminal, Multiple Organ Failure in Intensive Care.

Design outcomes

Primary

MeasureTime frameDescription
Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach55 monthsInitially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.
Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze timeliness of progressive palliative care approach55 monthsInitially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026