PACT-01: Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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clinical parameters;
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doctors' expectations regarding the continuation of anticancer treatment;
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patient expectations and preferences;
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the possibility of referring the patient to a supportive care specialist and strengthening home care.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Period A: Usual management Period of end-of-life care as usual |
Other: Usual care
Patients receiving systemic anticancer treatment in their last days of life
|
| Other: Period B: Process of optimization of the medical decision Period of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment. |
Other: Optimization of the medical decision
Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients receiving systemic anticancer treatment in their last days of life [24 months]
Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period
Secondary Outcome Measures
- Percentage of chemotherapy [24 months]
Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,
- Number of emergency room visits [24 months]
Percentage of patients visiting emergency room visits more than once and of unplanned hospitalizations and intensive care admission in the last month of life.
- Percentage of initiation of a new line of chemotherapy [24 months]
Percentage of initiation of a new line of chemotherapy (IV, oral) in the last month of life
- Percentage of immunotherapy and of Tyrosine kinase inhibitor [24 months]
Percentage of immunotherapy and of Tyrosine kinase inhibitor in the last 60, 30 and 14 days of life.
- Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy [24 months]
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life.
- Use of supportive care [24 months]
Frequency and precocity of use of supportive care.
- Overall survival (OS) [24 months]
Overall survival (OS) defined as the time from the date of consent to the date of death due to any cause.
- 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 [24 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
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Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
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Patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago).
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ECOG Performance Status ≥ 2.
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Age ≥ 18.
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Written informed consent.
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Patient capable, according to the investigator, to comply with the requirements of the study.
Exclusion Criteria:
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Small Cell Lung Cancer (including mixed forms).
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Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
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Impossible follow up for geographical, social or psychological reason.
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Inability to answer a questionnaire (language or neurological barrier).
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Patient under guardianship.
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Patient being treated in a therapeutic trial.
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Patient not covered by social security. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Abbeville | Abbeville | France | 80142 | |
| 2 | CH du Pays d'Aix | Aix-en-Provence | France | 13616 | |
| 3 | CHU Amiens - Hôpital Sud | Amiens | France | 80054 | |
| 4 | CHU Angers | Angers | France | 49933 | |
| 5 | CHR Metz-Thionville - Hôpital de Mercy | Ars-Laquenexy | France | ||
| 6 | CH Henri Duffaut Avignon | Avignon | France | 84000 | |
| 7 | Institut Sainte-Catherine | Avignon | France | 84918 | |
| 8 | AP-HP Ambroise Paré | Boulogne-Billancourt | France | 92100 | |
| 9 | CHI de Compiègne-Noyon | Compiègne | France | 60200 | |
| 10 | CHU Sud Francilien | Corbeil-Essonnes | France | 91100 | |
| 11 | Clinique des Cèdres | Cornebarrieu | France | 31700 | |
| 12 | CH Intercommunal de Créteil | Créteil | France | 94000 | |
| 13 | CGFL | Dijon | France | 21000 | |
| 14 | CHU Grenoble Alpes | Grenoble | France | 38043 | |
| 15 | CHD Vendée | La Roche-sur-Yon | France | 85925 | |
| 16 | CHRU Lille | Lille | France | 59000 | |
| 17 | Centre Léon Bérard | Lyon | France | 69008 | |
| 18 | Institut Curie | Paris | France | 75005 | |
| 19 | AP-HP Cochin | Paris | France | 75014 | |
| 20 | AP-HP Bichat | Paris | France | 75018 | |
| 21 | AP-HP Tenon | Paris | France | 75970 | |
| 22 | Institut Curie | Saint-Cloud | France | 92210 | |
| 23 | CH Saint-Malo | Saint-Malo | France | 35420 | |
| 24 | Hôpital Foch | Suresnes | France | 92150 | |
| 25 | Clinique Tessier | Valenciennes | France | 59300 |
Sponsors and Collaborators
- Institut Curie
Investigators
- Principal Investigator: Marie-Ange MASSIANI, MD, Institut Curie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC 2020-05