Early Palliative Care in Metastatic Lung Cancer in Northern France

Study Overview
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Brief Summary
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Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer

Detailed Description
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144 patients will be included; 72 per arm. Standard Control arm: patient supported by the onco-respiratory service. Intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care. The main criterion of judgment is the TOI score measured at 12 weeks. FACTL questionnaires, HADS and PHQ-9 will be filled out before randomization , at 12 weeks and 21 weeks

Official Title
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Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France

Conditions
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Lung Cancer Metastatic

Intervention / Treatment
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* Other: multi disciplinary palliative care monthly consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with non-small cell lung cancer Proven histologically Metastatic proven imaging (MRI, CT Scanner, PET scan) Stage IV (any T, any N, M1) prior to secondary chemotherapy treatment. Age> 18 years PS ≤2 Patient able to understand the nature, purpose and methodology of the study signed Informed consent Exclusion Criteria: Age <18 years Patient already supported by palliative care Patient with an activating EGFR mutation or EML4-ALK rearrangement or ROS1 gene translocation Patient under trusteeship / guardianship

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 |
| --- | --- |
| No Intervention: Control arm<br>Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications. | |
| Experimental: intervention arm<br>Multi disciplinary palliative care monthly consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a chaplain in addition to standard onco-pneumologic care. | Other: multi disciplinary palliative care monthly consultations<br>* multi disciplinary palliative care consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a worship person.The primary consultation within 3 weeks inclusion and then every month at the same time that consultations onco-respiratory<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life is measured at 12 weeks by the TOI score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SURVIVAL |  | from baseline | 
| EVENTS | presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths | 14 days before deaths | 
| QUALITY OF LIFE | quality of life is measured by the score TOI at 12 weeks and by the Echelle SCNS - SF34 scale, FACTL, PHQ-9 and HADS questionnaires at 12 and 21 weeks | 12 and 21 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Early palliative care, Lung cancer