Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Oscar Lambret

About this trial

This is a multicenter, national, interventional, cluster-randomized study, "stepped wedge" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged 18 years and older;

Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;

Currently undergoing systemic palliative treatment (no prospect of cure);

Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);

Disqualifiers

PS (WHO) = 4;

Patient receiving end-of-life care;

Patient opposed to the use of medical data for research purposes;

Person deprived of liberty or under guardianship;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Early integrated palliative care

    Other intervention

    Patients receive early integrated palliative care at the time of unplanned hospitalization for metastatic or advanced cancer. The intervention includes: * A palliative care consultation * A consultation with the treating oncologist * A multidisciplinary onco-palliative meeting to define a coordinated care plan

  • Usual oncological care

    Other intervention

    Patients receive standard oncological care according to institutional practices. Palliative care is provided only when clinically indicated, without systematic early consultation at the time of unplanned hospitalization.

Treatment groups

493 Participants
are divided into 2 treatment groups
Group A: Early integrated palliative careExperimental treatment 1 intervention
Group B: Usual oncological careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Aggressiveness of end-of-life care (composite endpoint)

Treatment will be considered aggressive if at least one of the following criteria is met (composite criterion): * Administration of systemic IV treatment (chemotherapy, targeted therapy, immunotherapy) within 14 days prior to death * At least one visit to the emergency room within 30 days prior to death * At least one admission to intensive care within 30 days prior to death * At least one admission to resuscitation within 30 days prior to death * Death in hospital outside of palliative care

Time frame
Assessed during the last 30 days of life and up to 14 days before death

Secondary outcomes

1

Components and additional indicators of aggressiveness of end-of-life care

Each component of the primary composite endpoint will be analyzed separately, including: intravenous systemic anticancer therapy within 14 days before death, ≥1 emergency department visit within 30 days before death, ≥1 intensive care unit admission within 30 days before death, ≥1 resuscitation unit admission within 30 days before death, and hospital death outside a palliative care unit. Additional indicators of aggressiveness will also be evaluated: initiation of a new line of systemic therapy within 30 days before death, number of hospitalizations in the last 30 days of life, cumulative duration of hospitalization in the last 30 days of life, number of emergency department visits, ICU admissions, resuscitation admissions, and palliative care admission within the last 3 days of life.

Time frame
Assessed during the last 30 days of life and up to 14 days before death
2

Overall survival

Overall survival will be defined as the time from the date of the unplanned hospitalization leading to study inclusion until the date of death from any cause.

Time frame
From study inclusion until death from any cause (follow-up up to 12 months)
3

Quality of life EORTC QLQ-C30 questionnaire

Quality of life will be assessed using the EORTC QLQ-C30 questionnaire at baseline and every 3 months.

Time frame
Baseline and every 3 months until death or up to 12 months
4

Quality of life MQOL-R questionnaire

The quality of life will be evaluated via the McGill Quality of Life-Revised (MQOL-R) questionnaire at baseline and every 3 months.

Time frame
Baseline and every 3 months until death or up to 12 months

Other outcomes

Sponsors and contacts

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