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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00514-43 | Other Identifier | ID-RCB number, ANSM |
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sponsor decision
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| Name | Class |
|---|---|
| Santelys Association | OTHER |
| Novartis | INDUSTRY |
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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
144 patients will be included; 72 per arm.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications. | |
| intervention arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi disciplinary palliative care monthly consultations | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | quality of life is measured at 12 weeks by the TOI score | 12 weeks |
| 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 |
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Inclusion Criteria:
Being diagnosed with non-small cell lung cancer
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:
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| Name | Affiliation | Role |
|---|---|---|
| Licia Touzet, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20818875 | Background | Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |