Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.

NCT ID: NCT04823377

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2027-09-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Period A: Usual management

Period of end-of-life care as usual

Group Type OTHER

Usual care

Intervention Type OTHER

Patients receiving systemic anticancer treatment in their last days of life

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.

Group Type OTHER

Optimization of the medical decision

Intervention Type OTHER

Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care

Interventions

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Usual care

Patients receiving systemic anticancer treatment in their last days of life

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Ange MASSIANI, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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CH Abbeville

Abbeville, , France

Site Status

CH du Pays d'Aix

Aix-en-Provence, , France

Site Status

CHU Amiens - Hôpital Sud

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CHR Metz-Thionville - Hôpital de Mercy

Ars-Laquenexy, , France

Site Status

CH Henri Duffaut Avignon

Avignon, , France

Site Status

Institut Sainte-Catherine

Avignon, , France

Site Status

AP-HP Ambroise Paré

Boulogne-Billancourt, , France

Site Status

CHI de Compiègne-Noyon

Compiègne, , France

Site Status

CHU Sud Francilien

Corbeil-Essonnes, , France

Site Status

Clinique des Cèdres

Cornebarrieu, , France

Site Status

CH Intercommunal de Créteil

Créteil, , France

Site Status

CGFL

Dijon, , France

Site Status

CHU Grenoble Alpes

Grenoble, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut Curie

Paris, , France

Site Status

AP-HP Cochin

Paris, , France

Site Status

AP-HP Bichat

Paris, , France

Site Status

AP-HP Tenon

Paris, , France

Site Status

Institut Curie

Saint-Cloud, , France

Site Status

CH Saint-Malo

St-Malo, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Clinique Tessier

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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IC 2020-05

Identifier Type: -

Identifier Source: org_study_id

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