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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PACT-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823377
• Other study ID #: IC 2020-05
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: September 20, 2026

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: Marie-Ange MASSIANI, MD
• Phone: +33 1 47 11 15 15
• Email: marieange.massiani[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: September 20, 2026
• Est. primary completion date: September 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• Usual care
Patients receiving systemic anticancer treatment in their last days of life
• 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

Locations

Country	Name	City	State
France	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	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	AP-HP Bichat	Paris
France	AP-HP Cochin	Paris
France	AP-HP Tenon	Paris
France	Institut Curie	Paris
France	Institut Curie	Saint-Cloud
France	CH Saint-Malo	Saint-Malo
France	Hôpital Foch	Suresnes
France	Clinique Tessier	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients receiving systemic anticancer treatment in their last days of life	Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period	24 months
Secondary	Percentage of chemotherapy	Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,	24 months
Secondary	Number of emergency room visits	Percentage of patients visiting emergency room visits more than once and of unplanned hospitalizations and intensive care admission in the last month of life.	24 months
Secondary	Percentage of initiation of a new line of chemotherapy	Percentage of initiation of a new line of chemotherapy (IV, oral) in the last month of life	24 months
Secondary	Percentage of immunotherapy and of Tyrosine kinase inhibitor	Percentage of immunotherapy and of Tyrosine kinase inhibitor in the last 60, 30 and 14 days of life.	24 months
Secondary	Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy	Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life.	24 months
Secondary	Use of supportive care	Frequency and precocity of use of supportive care.	24 months
Secondary	Overall survival (OS)	Overall survival (OS) defined as the time from the date of consent to the date of death due to any cause.	24 months
Secondary	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	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.	24 months