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

Not Applicable

Recruiting

• Conditions: Advanced Cancer; Carcinoma, Non-Small-Cell Lung

• 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.

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Study Start: 2021-09-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-09-23
• Study Completion: 2027-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 364

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

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
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.
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.

Trial Locations

Locations (24)

CH Abbeville; 🇫🇷 Abbeville, France

CH du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHU Amiens - Hôpital Sud; 🇫🇷 Amiens, 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

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