An interventional study of Early integrated palliative care and Usual oncological care in Cancer, Sarcoma Metastatic and Gynaecologic Cancer, sponsored by Centre Oscar Lambret. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Health services research
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.
This study will aim to evaluate the effectiveness of early palliative care for patients with metastatic or advanced cancer identified through unscheduled hospitalization in terms of reducing "aggressive" treatment.
Other objectives of the study include :
Compare approaches in terms of overall survival, treatment toxicities, advance directives, quality of life, anxiety, and depression.
Exclusion Criteria:
Patients receive early integrated palliative care following an unplanned hospitalization for metastatic or advanced cancer. The intervention includes a palliative care consultation, consultation with the treating oncologist, and a multidisciplinary onco-palliative discussion to define a shared care strategy. Implementation of an early collaboration between oncologists and palliative care physicians. At the time of unplanned hospitalization, patients receive a palliative care consultation, a consultation with their oncologist, and a multidisciplinary discussion (onco-palliative meeting) to define a coordinated care strategy.
Other: Early integrated palliative care
Patients receive standard oncological management without systematic early involvement of palliative care. Palliative care may be introduced according to usual clinical practice. Standard oncological care provided according to institutional practices without systematic early palliative care consultation at the time of unplanned hospitalization.
Other: Usual oncological care
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
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.
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
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
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)
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
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
Psychological distress and care pathway indicators
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and every 3 months. Additional indicators related to the care pathway will also be collected, including the presence of advance directives and the number of oncology consultations, palliative care consultations, and multidisciplinary onco-palliative meetings during follow-up.
Time frame: Baseline and every 3 months until death or up to 12 months
Time Until Definitive Deterioration
The Time Until Definitive Deterioration (TUDD) will be calculated from MQOL-R scores. Definitive deterioration is defined as a decrease of at least 1 point from baseline without any subsequent improvement greater than 1 point above the baseline score. TUDD will be defined as the time from inclusion to the first observation of definitive deterioration or death.
Time frame: Baseline and every 3 months until death or up to 12 months
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Centre Oscar Lambret