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

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

Status: Completed

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

Treatments: Other: palliative care

Study type: Observational

Funder types: Other

Identifiers

NCT06909968

IRST100.45

Details and patient eligibility

About

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.

Full 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

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

178 participants in 3 patient groups

Cancer patients

Description:

cancer patients with first diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma

Treatment:

Other: palliative care

Chronic pulmonary failure

Description:

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

Treatment:

Other: palliative care

Chronic renal failure

Description:

patients with advanced chronic renal failure

Treatment:

Other: palliative care