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

NCT07490106 | Not Yet Recruiting

• 3 other identifiers: SPPC-2503PREPS-24-00532025-A02238-41
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metastatic or Locally Advanced digestive, gynecological, ENT, or sarcoma cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Assessed during the last 30 days of life and up to 14 days before death

Secondary Outcomes (6)

• 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

• Overall survival

  From study inclusion until death from any cause (follow-up up to 12 months)

• Quality of life

  Baseline and every 3 months until death or up to 12 months

• Quality of life

  Baseline and every 3 months until death or up to 12 months

• Psychological distress and care pathway indicators

  Baseline and every 3 months until death or up to 12 months

Study Arms (2)

Early integrated palliative care

EXPERIMENTAL

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

Usual oncological care

ACTIVE COMPARATOR

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

Interventions

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

Early integrated palliative care

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.

Usual oncological care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

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  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fanny BEN OUNE

CONTACT

+33320295896; promotion@o-lambret.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)