Clinical trial NCT04823377: Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
Official title: Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Advanced Cancer
Keywords: cancer therapy
last days of life
optimization device
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
2. Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
3. 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).
4. ECOG Performance Status ≥ 2.
5. Age ≥ 18.
6. Written informed consent.
7. Patient capable, according to the investigator, to comply with the requirements of the study.

Exclusion Criteria:

1. Small Cell Lung Cancer (including mixed forms).
2. Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
3. Impossible follow up for geographical, social or psychological reason.
4. Inability to answer a questionnaire (language or neurological barrier).
5. Patient under guardianship.
6. Patient being treated in a therapeutic trial.
7. Patient not covered by social security. -

Primary outcomes:
measure: Percentage of patients receiving systemic anticancer treatment in their last days of life
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of chemotherapy
timeFrame: 24 months
measure: Number of emergency room visits
timeFrame: 24 months
measure: Percentage of initiation of a new line of chemotherapy
timeFrame: 24 months
measure: Percentage of immunotherapy and of Tyrosine kinase inhibitor
timeFrame: 24 months
measure: Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy
timeFrame: 24 months
measure: Use of supportive care
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Aix-en-Provence
country: France
facility: CH du Pays d'Aix
city: Amiens
country: France
facility: CHU Amiens - Hôpital Sud
city: Angers
country: France
facility: CHU Angers
city: Ars-Laquenexy
country: France
facility: CHR Metz-Thionville - Hôpital de Mercy
city: Avignon
country: France
facility: CH Henri Duffaut Avignon
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Boulogne-Billancourt
country: France
facility: AP-HP Ambroise Paré
city: Compiègne
country: France
facility: CHI de Compiègne-Noyon
city: Corbeil-Essonnes
country: France
facility: CHU Sud Francilien
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Créteil
country: France
facility: CH Intercommunal de Créteil
city: Dijon
country: France
facility: CGFL
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: AP-HP Cochin
city: Paris
country: France
facility: AP-HP Bichat
city: Paris
country: France
facility: AP-HP Tenon
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-Malo
country: France
facility: CH Saint-Malo
city: Suresnes
country: France
facility: Hôpital Foch
city: Valenciennes
country: France
facility: Clinique Tessier
Study officials:
affiliation: Institut Curie
name: Marie-Ange MASSIANI, MD
role: PRINCIPAL_INVESTIGATOR
References: