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| ID | Type | Description | Link |
|---|---|---|---|
| PREPS-24-0053 | Other Grant/Funding Number | DGOS | |
| 2025-A02238-41 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| Assessed during the last 30 days of life and up to 14 days before death |
| Measure | Description | Time Frame |
|---|---|---|
| Components and additional indicators of aggressiveness of end-of-life care | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanny BEN OUNE | Contact | +33320295896 | promotion@o-lambret.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3657724 | Background | Kovac T. [Protein glycolysation]. Med Pregl. 1987;40(1-2):55-9. No abstract available. Croatian. | |
| 35045221 | Background | 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 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19. |
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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.
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|
| 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. |
|
| Assessed during the last 30 days of life and up to 14 days before death |
| Overall survival | 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 | 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 | 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 | 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 | 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 |
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| Background | 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. |
| Background | Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa |
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| Background | Mignonat-Lecoanet C., Nahapetian H., Lecoanet A., Filbet M., " Modalités d'appel des soins palliatifs : enquête auprès des oncologues ", Médecine Palliative : Soins de Support - Accompagnement - Éthique, Volume 16, Issue 2, 2017, Pages 70-80, ISSN 1636-6522, https://doi.org/10.1016/j.medpal.2017.01.001 |
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| 39526177 | Background | Adenis A, Da Silva A, Ben Abdelghani M, Bourgeois V, Bogart E, Turpin A, Evin A, Proux A, Galais MP, Jaraudias C, Quintin J, Bouquet G, Samalin E, Bremaud N, Javed S, Henry A, Kurtz JE, Cornuault-Foubert D, Vandamme H, Lucchi E, Pannier D, Belletier C, Paul M, Touzet L, Penel N, Chvetzoff G, Le Deley MC. Early palliative care and overall survival in patients with metastatic upper gastrointestinal cancers (EPIC): a multicentre, open-label, randomised controlled phase 3 trial. EClinicalMedicine. 2024 Jun 28;74:102470. doi: 10.1016/j.eclinm.2024.102470. eCollection 2024 Aug. |
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| Background | F. Worms, le moment du soin - A quoi tenons-nous ? Chapitre 1 : les deux concepts du soin. Presses Universitaires de France, Paris, 2021 |
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| 37331369 | Background | Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, Garcia-Alfonso P, Kocsis J, Cubillo Gracian A, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Paulson AS, Masuishi T, Jones J, Csoszi T, Cremolini C, Ghiringhelli F, Shergill A, Hochster HS, Krauss J, Bassam A, Ducreux M, Elme A, Faugeras L, Kasper S, Van Cutsem E, Arnold D, Nanda S, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023 Jul 1;402(10395):41-53. doi: 10.1016/S0140-6736(23)00772-9. Epub 2023 Jun 15. |
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| Background | Defossez G, Le Guyader-Peyrou S, Uhry Z, Grosclaude P, Colonna M, Dantony E, et al. Estimations nationales de l'incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018. Volume 1 - Tumeurs solides. Saint-Maurice (Fra) : Santé publique France, 2019. 372 p. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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