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| Name | Class |
|---|---|
| Regione Emilia-Romagna | OTHER |
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This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.
The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.
Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.
Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Palliative Care | Experimental | Subjects receive standard of care with early palliative care. |
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| Standard of Care | No Intervention | Subjects receive standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Palliative Care | Other | Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure) | compare change in QOL from baseline to 12 weeks between study arms | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | from date of randomization until date of death or for a minimum of six months | |
| Resource utilization at the end of life (EOL): chemotherapy utilization | percentage of patients who died, that in the 30 days preceding the death received chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VITTORIO FRANCIOSI, M.D. | UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| From date of randomization until death or for a minimum of six months after enrollment |
| Resource utilization at the end of life (EOL): hospital admissions | percentage of patients who died, that in the 30 days preceding the death were admitted to hospital | From date of randomization until death or for a minimum of six months after enrollment |
| Resource utilization at the end of life (EOL): emergency room admissions | percentage of patients who died, that in the 30 days preceding the death went to the emergency room | From date of randomization until death or for a minimum of six months after enrollment |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |