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

March 19, 2026 updated by: Centre Oscar Lambret
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

493

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early integrated palliative care
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 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
Active Comparator: Usual oncological 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed during the last 30 days of life and up to 14 days before death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed during the last 30 days of life and up to 14 days before death
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.
From study inclusion until death from any cause (follow-up up to 12 months)
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.
Baseline and every 3 months until death or up to 12 months
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.
Baseline and every 3 months until death or up to 12 months
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.
Baseline and every 3 months until death or up to 12 months
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.
Baseline and every 3 months until death or up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPPC-2503
  • PREPS-24-0053 (Other Grant/Funding Number: DGOS)
  • 2025-A02238-41 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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