Cancer, Digestive Cancers, ENT Cancer, Gynaecologic Cancer, Metastatic Cancer or Locally Advanced, Sarcoma Metastatic
Conditions
Keywords
Metastatic or Locally Advanced digestive, gynecological, ENT, or sarcoma cancer
Brief summary
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.
Detailed description
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. * Describing care according to the organization at the time of inclusion. * Evaluating the economic impact of early palliative care in patients with metastatic or advanced cancer through a medico-economic analysis combining cost-effectiveness and cost-utility analysis. * Evaluating interactions between the various stakeholders (palliative care physicians, supportive care physicians, oncologists).
Interventions
OTHEREarly integrated palliative 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
OTHERUsual oncological care
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.
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study is a multicenter, national, phase III cluster-randomized stepped-wedge trial evaluating the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization. Participating centers represent the clusters. All centers start in the control phase (usual care) and subsequently cross over to the intervention phase according to a randomized implementation schedule. Clusters are randomized to the timing of implementation of the early palliative care intervention (12 or 24 months after study initiation). Randomization is stratified according to the expected recruitment rate per center (≤2 versus \>2 patients per month). This design allows sequential implementation of the intervention across centers while enabling comparison between control and intervention periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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); * Patient covered by the French social security system; * Informed consent, written and signed.
Exclusion criteria
* 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; * Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aggressiveness of end-of-life care (composite endpoint) | Assessed during the last 30 days of life and up to 14 days before death | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Components and additional indicators of aggressiveness of end-of-life care | Assessed during the last 30 days of life and up to 14 days before death | 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. |
| Overall survival | From study inclusion until death from any cause (follow-up up to 12 months) | 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. |
| Quality of life EORTC QLQ-C30 questionnaire | Baseline and every 3 months until death or up to 12 months | Quality of life will be assessed using the EORTC QLQ-C30 questionnaire at baseline and every 3 months. |
| Quality of life MQOL-R questionnaire | Baseline and every 3 months until death or up to 12 months | The quality of life will be evaluated via the McGill Quality of Life-Revised (MQOL-R) questionnaire at baseline and every 3 months. |
| Psychological distress and care pathway indicators | Baseline and every 3 months until death or up to 12 months | 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 Until Definitive Deterioration | Baseline and every 3 months until death or up to 12 months | 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. |
Countries
France
Contacts
CONTACTFanny BEN OUNE
Outcome results
None listed