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NCT Number: NCT07490106

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early integrated palliative care

Other

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

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Overall survival

    Time frame: 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.

  3. Quality of life

    Time frame: 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.

  4. Quality of life

    Time frame: 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.

  5. Psychological distress and care pathway indicators

    Time frame: 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.

  6. Time Until Definitive Deterioration

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny BEN OUNE

CONTACT

[email protected]

+33320295896

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Acronym: SPPC

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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