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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; Chronic Renal Failure
• Intervention / Treatment: Other: palliative care

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

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Italy
  • Meldola, Italy, 47014
    • IRST IRCCS UO Cure Palliative
  • BO
    • Bologna, BO, Italy, 40124
      • Rete Cure Palliative AUSL Bologna
    • Bologna, BO, Italy, 40138
      • U.O. Nefrologia, Dialisi e Trapianto Renale, Policlinico Sant'Orsola
    • Bologna, BO, Italy, 40138
      • U.O. Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant'Orsola
  • FC
    • Forlì, FC, Italy, 47121
      • U.O. Nefrologia e Dialisi, Ospedale Morgagni-Pierantoni - Ospedale M. Bufalini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients; cancer patients with first diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma	Other: palliative 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.
Chronic pulmonary failure; patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).	Other: palliative 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.
Chronic renal failure; patients with advanced chronic renal failure	Other: palliative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach	Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.	55 months
Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze timeliness of progressive palliative care approach	Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.	55 months

Collaborators and Investigators

• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
• Investigators: Study Chair: Marco C Maltoni, MD, Irst Irccs

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): October 17, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: palliative care; cancer; chronic renal failure; appropriateness; chronic pulmonary failure
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Renal Insufficiency; Lung Diseases, Interstitial; Renal Insufficiency, Chronic; Pulmonary Fibrosis; Pathological Conditions, Signs and Symptoms; Neoplasms; Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis; Kidney Failure, Chronic; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: IRST100.45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No