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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Chronic pulmonary failure | patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF). |
| |
| Chronic renal failure | patients with advanced chronic renal failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Inclusion Criteria specific for POPULATION A:
Inclusion Criteria specific for POPULATION B:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Marco C Maltoni, MD | IRST IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rete Cure Palliative AUSL Bologna | Bologna | BO | 40124 | Italy | ||
| U.O. Nefrologia, Dialisi e Trapianto Renale, Policlinico Sant'Orsola |
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|
| Bologna |
| BO |
| 40138 |
| Italy |
| U.O. Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant'Orsola | Bologna | BO | 40138 | Italy |
| U.O. Nefrologia e Dialisi, Ospedale Morgagni-Pierantoni - Ospedale M. Bufalini | Forlì | FC | 47121 | Italy |
| IRST IRCCS UO Cure Palliative | Meldola | 47014 | Italy |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007676 | Kidney Failure, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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