Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
- Conditions
- Advanced CancerCarcinoma, Non-Small-Cell Lung
- Interventions
- Other: Optimization of the medical decisionOther: Usual care
- Registration Number
- NCT04823377
- Lead Sponsor
- Institut Curie
- 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.
- 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:
1. clinical parameters;
2. doctors' expectations regarding the continuation of anticancer treatment;
3. patient expectations and preferences;
4. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 364
- Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
- Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
- 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).
- ECOG Performance Status ≥ 2.
- Age ≥ 18.
- Written informed consent.
- Patient capable, according to the investigator, to comply with the requirements of the study.
- Small Cell Lung Cancer (including mixed forms).
- Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
- Impossible follow up for geographical, social or psychological reason.
- Inability to answer a questionnaire (language or neurological barrier).
- Patient under guardianship.
- Patient being treated in a therapeutic trial.
- Patient not covered by social security. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period B: Process of optimization of the medical decision Optimization of the medical decision Period of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment. Period A: Usual management Usual care Period of end-of-life care as usual
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Use of supportive care 24 months Frequency and precocity of use of supportive care.
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 chemotherapy 24 months Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days 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 initiation of Tyrosine kinase inhibitor or immunotherapy 24 months Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life.
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.
Trial Locations
- Locations (24)
CHU Amiens - Hôpital Sud
🇫🇷Amiens, France
CH Abbeville
🇫🇷Abbeville, France
CH du Pays d'Aix
🇫🇷Aix-en-Provence, France
CHU Angers
🇫🇷Angers, France
CHR Metz-Thionville - Hôpital de Mercy
🇫🇷Ars-Laquenexy, France
CH Henri Duffaut Avignon
🇫🇷Avignon, France
Institut Sainte-Catherine
🇫🇷Avignon, France
AP-HP Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHI de Compiègne-Noyon
🇫🇷Compiègne, France
CHU Sud Francilien
🇫🇷Corbeil-Essonnes, France
Clinique des Cèdres
🇫🇷Cornebarrieu, France
CH Intercommunal de Créteil
🇫🇷Créteil, France
CGFL
🇫🇷Dijon, France
CHU Grenoble Alpes
🇫🇷Grenoble, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
CHRU Lille
🇫🇷Lille, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Curie
🇫🇷Saint-Cloud, France
AP-HP Bichat
🇫🇷Paris, France
CH Saint-Malo
🇫🇷Saint-Malo, France
AP-HP Tenon
🇫🇷Paris, France
Hôpital Foch
🇫🇷Suresnes, France
Clinique Tessier
🇫🇷Valenciennes, France
AP-HP Cochin
🇫🇷Paris, France