Menu
Not yet recruiting NCT07490106

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

No phase Interventional Cancer Sarcoma Metastatic Gynaecologic Cancer Digestive Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early integrated palliative care, Usual oncological care.
Who it may be relevant to
Registry conditions: Cancer, Sarcoma Metastatic, Gynaecologic Cancer, Digestive Cancers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]
  • Overall survival [Time frame: 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 [Time frame: 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]
  • Time Until Definitive Deterioration [Time frame: Baseline and every 3 months until death or up to 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Centre Oscar Lambret — Lille

Publications

  • Kovac T. [Protein glycolysation]. Med Pregl. 1987;40(1-2):55-9. No abstract available. Croatian. PMID 3657724
  • Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Fe PMID 35045221
  • Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gomez-Puerto D, Lopez-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berche R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Munoz-Couselo E, Martinez-Marti A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Elez E, Felip PMID 39529819
  • Patel TL, Bouchal SR, Laing CM, Hubbard S. Diminuer le recours au service des urgences pour les patients externes presentant des symptomes aigus de cancer : revue integrative sur l'emergence des centres de soins d'urgence en cancerologie. Can Oncol Nurs J. 2021 Feb 1;31(1):36-50. doi: 10.5737/236880763113650. eCollection 2021 Winter. French. PMID 38919462
  • Paillé, P. et Mucchielli, A. (2021). Chapitre 12. L'analyse thématique. L'analyse qualitative en sciences humaines et sociales - 5e éd. (p. 269 -357). Armand Colin. https://shs.cairn.info/l-analyse-qualitative-en-sciences-humaines--9782200624019-page-69?lang=fr.
  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
  • Hemming K, Taljaard M. Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice? Int J Epidemiol. 2020 Jun 1;49(3):1043-1052. doi: 10.1093/ije/dyaa077. PMID 32386407
  • Whynes DK; TOMBOLA Group. Responsiveness of the EQ-5D to HADS-identified anxiety and depression. J Eval Clin Pract. 2009 Oct;15(5):820-5. doi: 10.1111/j.1365-2753.2008.01102.x. PMID 19811595

Identifiers

NCT: NCT07490106 · SPPC-2503 · PREPS-24-0053 · 2025-A02238-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗