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Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.
We propose to study the optimization of this decision process in an advanced Non-Small-Cell Lung Carcinoma (NSCLC) population, with a Performance Status (PS) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating:
The process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision.
In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period A: Usual management | Other | Period of end-of-life care as usual |
|
| Period B: Process of optimization of the medical decision | Other | Period of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Other | Patients receiving systemic anticancer treatment in their last days of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients receiving systemic anticancer treatment in their last days of life | Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of chemotherapy | Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life, | 24 months |
| Number of emergency room visits | Percentage of patients visiting emergency room visits more than once and of unplanned hospitalizations and intensive care admission in the last month of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Ange MASSIANI, MD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Abbeville | Abbeville | 80142 | France | |||
| CH du Pays d'Aix |
Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
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| Optimization of the medical decision | Other | Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care |
|
| 24 months |
| Percentage of initiation of a new line of chemotherapy | Percentage of initiation of a new line of chemotherapy (IV, oral) in the last month of life | 24 months |
| Percentage of immunotherapy and of Tyrosine kinase inhibitor | Percentage of immunotherapy and of Tyrosine kinase inhibitor in the last 60, 30 and 14 days of life. | 24 months |
| Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy | Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life. | 24 months |
| Use of supportive care | Frequency and precocity of use of supportive care. | 24 months |
| Overall survival (OS) | Overall survival (OS) defined as the time from the date of consent to the date of death due to any cause. | 24 months |
| Quality of life using QLQ-C15-PAL EORTC (European Organization for Research and Treatment of Cancer) and anxiety with HAD (Hospital Anxiety and Depression) questionnaire | The quality of Life in palliative cancer care patients will be collected with QLQ-C15-PAL EORTC scale and anxiety will be mesured with HAD scale. | 24 months |
| Aix-en-Provence |
| 13616 |
| France |
| CHU Amiens - Hôpital Sud | Amiens | 80054 | France |
| CHU Angers | Angers | 49933 | France |
| CHR Metz-Thionville - Hôpital de Mercy | Ars-Laquenexy | France |
| CH Henri Duffaut Avignon | Avignon | 84000 | France |
| Institut Sainte-Catherine | Avignon | 84918 | France |
| AP-HP Ambroise Paré | Boulogne-Billancourt | 92100 | France |
| CHI de Compiègne-Noyon | Compiègne | 60200 | France |
| CHU Sud Francilien | Corbeil-Essonnes | 91100 | France |
| Clinique des Cèdres | Cornebarrieu | 31700 | France |
| CH Intercommunal de Créteil | Créteil | 94000 | France |
| CGFL | Dijon | 21000 | France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
| CHRU Lille | Lille | 59000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Curie | Paris | 75005 | France |
| AP-HP Cochin | Paris | 75014 | France |
| AP-HP Bichat | Paris | 75018 | France |
| AP-HP Tenon | Paris | 75970 | France |
| Institut Curie | Saint-Cloud | 92210 | France |
| CH Saint-Malo | St-Malo | 35420 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| Clinique Tessier | Valenciennes | 59300 | France |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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