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

NCT06909968 | Completed

• 1 other identifier: IRST100.45
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

Chronic pulmonary failure

patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).

Other: palliative care

Chronic renal failure

patients with advanced chronic renal failure

Other: palliative care

Interventions

palliative care OTHER

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.

Cancer patients; Chronic pulmonary failure; Chronic renal failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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;
• 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.
• \- 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.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (5)

Rete Cure Palliative AUSL Bologna

Bologna, BO, 40124, Italy

Location

U.O. Nefrologia, Dialisi e Trapianto Renale, Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

Location

U.O. Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

Location

U.O. Nefrologia e Dialisi, Ospedale Morgagni-Pierantoni - Ospedale M. Bufalini

Forlì, FC, 47121, Italy

Location

IRST IRCCS UO Cure Palliative

Meldola, 47014, Italy

Location

MeSH Terms

Conditions

Neoplasms; Kidney Failure, Chronic; Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marco C Maltoni, MD

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: December 14, 2020
• Primary Completion: February 26, 2025
• Study Completion: October 17, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-10

Locations

IT (5)