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

Centre Oscar Lambret

Status: Not yet enrolling

Conditions: Gynaecologic Cancer; Metastatic Cancer or Locally Advanced; Sarcoma Metastatic; Digestive Cancers; Cancer; ENT Cancer

Treatments: Other: Early integrated palliative care; Other: Usual oncological care

Study type: Interventional

Funder types: Other

Identifiers

NCT07490106

2025-A02238-41 (Other Identifier)

SPPC-2503

PREPS-24-0053 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 493 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

493 participants in 2 patient groups

Early integrated palliative care

Experimental group

Description:

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.

Treatment:

Other: Early integrated palliative care

Usual oncological care

Active Comparator group

Description:

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.

Treatment:

Other: Usual oncological care