Early Palliative Care on Quality of Life of Advanced Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial

Conditions
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Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Cancer, Biliary Tract Cancer

Intervention / Treatment
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* Other: Early Palliative Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization. Exclusion Criteria: Patients already receiving care from the PC service or pretreated with chemotherapy ± biological

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Palliative Care<br>Subjects receive standard of care with early palliative care. | Other: Early Palliative Care<br>* 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.<br>|
| No Intervention: Standard of Care<br>Subjects receive standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life