Lung Cancer Metastatic
Conditions
Keywords
Early palliative care, Lung cancer, Quality of life
Brief summary
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
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
Interventions
OTHERmulti disciplinary palliative care monthly consultations
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
Sponsors
Santelys Association
Novartis
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 12 weeks | quality of life is measured at 12 weeks by the TOI score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SURVIVAL | from baseline | — |
| EVENTS | 14 days before deaths | presence of any of the following: chemotherapy, use of resuscitation or no treatment limiting decision 14 days before deaths |
| QUALITY OF LIFE | 12 and 21 weeks | 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 |
Countries
France
Outcome results
None listed