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

NCT ID: NCT06909968

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2025-10-17

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

palliative care

Intervention Type: 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.

Chronic pulmonary failure

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

palliative care

Intervention Type: 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.

Chronic renal failure

patients with advanced chronic renal failure

palliative care

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco C Maltoni, MD

Role: STUDY_CHAIR

IRST IRCCS

Locations

Rete Cure Palliative AUSL Bologna

Bologna, BO, Italy

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

Bologna, BO, Italy

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

Bologna, BO, Italy

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

Forlì, FC, Italy

IRST IRCCS UO Cure Palliative

Meldola, , Italy

Countries

Italy

Other Identifiers

IRST100.45

Identifier Type: -

Identifier Source: org_study_id