Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. (PACT-01)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Advanced Cancer
• Intervention / Treatment: Other: Usual care; Other: Optimization of the medical decision

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 Type: Interventional
• Enrollment (Estimated): 364
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Abbeville, France, 80142
    • CH Abbeville
  • Aix-en-Provence, France, 13616
    • CH du Pays D'Aix
  • Amiens, France, 80054
    • CHU Amiens - Hopital Sud
  • Angers, France, 49933
    • CHU Angers
  • Ars-Laquenexy, France
    • CHR Metz-Thionville - Hôpital de Mercy
  • Avignon, France, 84918
    • Institut Sainte-Catherine
  • Avignon, France, 84000
    • CH Henri Duffaut Avignon
  • Boulogne-Billancourt, France, 92100
    • AP-HP Ambroise Paré
  • Compiègne, France, 60200
    • CHI de Compiègne-Noyon
  • Corbeil-Essonnes, France, 91100
    • CHU Sud Francilien
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Créteil, France, 94000
    • Ch Intercommunal de Creteil
  • Dijon, France, 21000
    • CGFL
  • Grenoble, France, 38043
    • Chu Grenoble Alpes
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • Lille, France, 59000
    • CHRU Lille
  • Lyon, France, 69008
    • Centre léon bérard
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75014
    • AP-HP Cochin
  • Paris, France, 75018
    • Ap-Hp Bichat
  • Paris, France, 75970
    • AP-HP Tenon
  • Saint-Cloud, France, 92210
    • Institut Curie
  • St-Malo, France, 35420
    • CH Saint-Malo
  • Suresnes, France, 92150
    • Hopital Foch
  • Valenciennes, France, 59300
    • Clinique Tessier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Period A: Usual management; Period of end-of-life care as usual	Other: Usual care; Patients receiving systemic anticancer treatment in their last days of life
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of chemotherapy	Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,	24 months
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
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
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
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
Use of supportive care	Frequency and precocity of use of supportive care.	24 months
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
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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Marie-Ange MASSIANI, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2027

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cancer therapy; last days of life; optimization device
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IC 2020-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No