Clinical trial NCT06909968: Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases
Official title: Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Chronic Renal Failure
Chronic Obstructive Pulmonary Disease
Idiopathic Pulmonary Fibrosis
Keywords: palliative care
appropriateness
cancer
chronic pulmonary failure
chronic renal failure
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Population A: cancer patients with first diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma.
* Population B: patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).
* Population C: patients with advanced 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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach
timeFrame: 55 months
measure: Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze timeliness of progressive palliative care approach
timeFrame: 55 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rete Cure Palliative AUSL Bologna
state: BO
city: Bologna
country: Italy
facility: U.O. Nefrologia, Dialisi e Trapianto Renale, Policlinico Sant'Orsola
state: BO
city: Bologna
country: Italy
facility: U.O. Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant'Orsola
state: BO
city: Forlì
country: Italy
facility: U.O. Nefrologia e Dialisi, Ospedale Morgagni-Pierantoni - Ospedale M. Bufalini
state: FC
city: Meldola
country: Italy
facility: IRST IRCCS UO Cure Palliative
Study officials:
affiliation: IRST IRCCS
name: Marco C Maltoni, MD
role: STUDY_CHAIR
References: