Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

Study Overview
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Brief Summary
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The objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. Feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. The study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach (stage IIIb-IV).

Official Title
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Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

Conditions
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Lung Cancer, Mesothelioma, Pancreas Cancer, Gastric Cancer

Intervention / Treatment
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* Other: The early palliative care programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients within 8 weeks of cancer diagnosis confirmed by histology or cytology lung cancer (NSCLC or SCLC) stage IIIb-IV OR mesothelioma stage III-IV OR pancreas cancer stage IV, OR gastric cancer stage IIIb-IV age more than 18 years performance status (ECOG) ≤ 2; ability to read, understand and fill-in the questionnaires written informed consent to the study Exclusion Criteria: any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early palliative care programme<br>Patients will be proposed to be followed by the Palliative Care Team | Other: The early palliative care programme<br>* The intervention consists of an early integration of a palliative care programme with the standard care performed by the oncologists-pneumologists that are following the cancer patients. The intervention will be delivered by the specialised Palliative Care Unit (PCU) of the hospital. Each patient meets the professionals of the PCU by 30 days by cancer diagnosis and at least monthly thereafter in the outpatint settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of cancer patients that accept and attend the early palliative care programme | percentage of eligible cancer patients that accept the proposal of the intervention (the early palliative care programme) and that, by 30 days after the diagnosis, effectively start to be followed by the Palliative Care Unit | up to 30 days after the diagnosis of cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists | percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme | up to 30 days after the diagnosis of cancer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, early palliative care, feasibility