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An Observational Study of the Prevalence of Patients Requiring Palliative Care in French Anti-cancer Centers. (PREPA-10)

16. august 2017 opdateret af: Centre Leon Berard

An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.

The purpose of this observational study is to determine the proportion of patients with a score greater than 3/10 to the questionnaire PALLIA-10.

This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at helping the providers of care to identify patients who would require palliative cares.

According to the notice of the questionnaire, patients with a score greater than 3 would be taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it seems that a large majority of patients would have a score greater than 3 in the context of anti cancer centers.

To date, palliative teams are not designed to take in charge such an amount of patients.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Continuous improvement of therapeutics helped to lengthen different stages of natural cancer evolution. Advanced cancer patients are followed-up even longer; therefore there is a need to increase palliative care resources. A global therapeutic approach is being set up gradually thanks to specialized supportive care team. This global approach includes therapeutics and life condition improvement of the patient and his family.

In France, only 2 anti-cancer centers have a palliative care unit. The 16 other centers design hospital beds for palliative care and work with mobile palliative care teams.

According to latest studies with high level of evidence, International oncology societies published good practices guidelines supporting the need of early palliative cares for patients with metastatic cancer.

In 2010, Temel et al. demonstrated early palliative care effectiveness. Indeed, early palliative care led to significant improvements in both quality of life (score on the FACT-L scale: 98.0 vs. 91.5; p=0.03) and mood (depressive symptoms: 16% vs. 38%, P=0.01). Moreover median survival was longer among patients receiving early palliative care (11.6 months vs. 8.9 months, p=0.02). Analysis showed that patients assigned to early palliative care stopped chemotherapy earlier, had a higher enrollment rate in palliative care units and less depressive symptoms when cares were provided by both oncologists and palliative care teams.

Other specific scales support efficiency of early palliative care on quality of life. Early palliative care increases also satisfaction of the cares. Therefore, these results illustrate the need for an early integration of palliative care in France; and this approach is recommended in the third national plan against cancer.

Despite efficacy data, no high international consensus exists on a screening score for patients requiring early palliative care. Some teams therefore use prognostic factors like Barbot score.

Confronted with such difficulties, the French Society for Counselling and Palliative Care create a score (PALLIA-10) with 10 items on personal situation of the patient and his disease. This score helps medical staffs to direct patients to a specialized team as soon as it is > 3/10.

PALLI-10 score is not optimized because of the large number of patients with a score > 3 in the French anti-cancer centers. In 2014, a team from Centre Fraçois Baclesse (Caen, France) showed that nearly 65% of hospitalized patients in medicine department has a score PALLIA-10 > 3/10. Today, mobile palliative care teams are too small to manage so many patients.

First, it is important to evaluate the prevalence of these patients in France. Description of patients hospitalized in a Center for the Treatment of Cancers should help us to describe the characteristics of patients requiring cares provided by a mobile palliative care team.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

846

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Angers, Frankrig, 49933
        • Institut de Cancérologie de l'Ouest
      • Bordeaux, Frankrig, 33076
        • Institut Bergonie
      • Caen, Frankrig, 14000
        • Centre Francois Baclesse
      • Clermont Ferrand, Frankrig, 63011
        • Centre Jean Perrin
      • Lille, Frankrig, 59020
        • Centre OSCAR LAMBRET
      • Lyon, Frankrig, 69008
        • Centre LEON BERARD
      • Marseille, Frankrig, 13009
        • Institut Paoli Calmettes
      • Montpellier, Frankrig, 34298
        • Institut Regional du Cancer de Montpellier
      • Nice, Frankrig, 06189
        • Centre Antoine Lacassagne
      • Paris - Saint Cloud, Frankrig, 75005
        • Institut Curie
      • Reims, Frankrig, 51726
        • Institut Jean Godinot
      • Rennes, Frankrig, 35000
        • Centre Eugene Marquis
      • Strasbourg, Frankrig, 67085
        • Centre Paul Strauss
      • Toulouse, Frankrig, 31059
        • Institut Universitaire du Cancer de Toulouse Oncopole
      • Vandoeuvre-lès-Nancy, Frankrig, 54519
        • Institut de Cancérologie de Lorraine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients hospitalized in a conventionnal medical service of a French anti cancer center.

Beskrivelse

Inclusion Criteria:

  • 18-year old or older
  • Hospitalized in a conventionnal medical service, including radiotherapy, brachytherapy, palliative care units.

Exclusion Criteria:

  • Patient hospitalized in an out-patient service, surgery unit, weekly units

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients with a score greater than 3/10 to questionnaire PALLIA-10 in the population of patients hospitalized in a French cancer center.
Tidsramme: Day 1 of the study
Day 1 of the study

Sekundære resultatmål

Resultatmål
Tidsramme
The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
Tidsramme: Day 1 of the study
Day 1 of the study
Proportion of patients already followed-up by a palliative care team
Tidsramme: Day 1 of the study
Day 1 of the study
Mean score to questionnaire PALLIA-10
Tidsramme: Day 1 of the study
Day 1 of the study
Predictive factors of current palliative cares
Tidsramme: Day 1 of the study
Day 1 of the study
Prognostic factors of overall survival
Tidsramme: From Day 1 of the study to the update of survival status (6 months later)
From Day 1 of the study to the update of survival status (6 months later)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Gisèle CHVETZOFF, MD, Centre LEON BERARD

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

19. juni 2015

Først indsendt, der opfyldte QC-kriterier

19. juni 2015

Først opslået (Skøn)

23. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PREPA-10

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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