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

Last updated: December 12, 2024
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Treatment

Optimization of the medical decision

Usual care

Clinical Study ID

NCT04823377
IC 2020-05
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofmetastatic disease (or in the context of locoregional disease if the lastchemotherapy 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 ofthe study.

Exclusion

Exclusion Criteria:

  1. Small Cell Lung Cancer (including mixed forms).

  2. Patient with NSCLC for whom a decision has already been made to permanentlydiscontinue 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. -

Study Design

Total Participants: 364
Treatment Group(s): 2
Primary Treatment: Optimization of the medical decision
Phase:
Study Start date:
September 24, 2021
Estimated Completion Date:
September 23, 2027

Study 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.

Connect with a study center

  • CH Abbeville

    Abbeville, 80142
    France

    Active - Recruiting

  • CH du Pays d'Aix

    Aix-en-Provence, 13616
    France

    Active - Recruiting

  • CHU Amiens - Hôpital Sud

    Amiens, 80054
    France

    Active - Recruiting

  • CHU Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHR Metz-Thionville - Hôpital de Mercy

    Ars-Laquenexy,
    France

    Active - Recruiting

  • CH Henri Duffaut Avignon

    Avignon, 84000
    France

    Active - Recruiting

  • Institut Sainte-Catherine

    Avignon, 84918
    France

    Active - Recruiting

  • AP-HP Ambroise Paré

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • CHI de Compiègne-Noyon

    Compiègne, 60200
    France

    Active - Recruiting

  • CHU Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Active - Recruiting

  • Clinique des Cèdres

    Cornebarrieu, 31700
    France

    Active - Recruiting

  • CH Intercommunal de Créteil

    Créteil, 94000
    France

    Active - Recruiting

  • CGFL

    Dijon, 21000
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble, 38043
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • CHRU Lille

    Lille, 59000
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69008
    France

    Active - Recruiting

  • HP-HM Marseille

    Marseille, 13915
    France

    Site Not Available

  • AP-HP Bichat

    Paris, 75018
    France

    Active - Recruiting

  • AP-HP Cochin

    Paris, 75014
    France

    Active - Recruiting

  • AP-HP Tenon

    Paris, 75970
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie

    Saint-Cloud, 92210
    France

    Active - Recruiting

  • CH Saint-Malo

    Saint-Malo, 35420
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92150
    France

    Active - Recruiting

  • Clinique Tessier

    Valenciennes, 59300
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.