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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2026
  • participants needed
    364
  • sponsor
    Institut Curie
Updated on 4 October 2022
carcinoma
cancer treatment
cancer chemotherapy
lung carcinoma

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.

Details
Condition Carcinoma, Non-Small-Cell Lung, Advanced Cancer
Treatment Usual Care, Optimization of the medical decision
Clinical Study IdentifierNCT04823377
SponsorInstitut Curie
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction
Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
ECOG Performance Status ≥ 2
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)
Age ≥ 18
Written informed consent
Patient capable, according to the investigator, to comply with the requirements of the study

Exclusion Criteria

Small Cell Lung Cancer (including mixed forms)
Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment
Impossible follow up for geographical, social or psychological reason
Inability to answer a questionnaire (language or neurological barrier)
Patient under guardianship
Patient being treated in a therapeutic trial
Patient not covered by social security. -
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