- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02479061
An Observational Study of the Prevalence of Patients Requiring Palliative Care in French Anti-cancer Centers. (PREPA-10)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Angers, França, 49933
- Institut de cancérologie de l'ouest
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Bordeaux, França, 33076
- Institut Bergonié
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Caen, França, 14000
- Centre Francois Baclesse
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Clermont Ferrand, França, 63011
- Centre Jean Perrin
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Lille, França, 59020
- Centre Oscar Lambret
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Lyon, França, 69008
- Centre Leon Berard
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Marseille, França, 13009
- Institut Paoli Calmettes
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Montpellier, França, 34298
- Institut Régional du Cancer de Montpellier
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Nice, França, 06189
- Centre Antoine Lacassagne
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Paris - Saint Cloud, França, 75005
- Institut Curie
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Reims, França, 51726
- Institut Jean Godinot
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Rennes, França, 35000
- Centre Eugene Marquis
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Strasbourg, França, 67085
- Centre Paul Strauss
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Toulouse, França, 31059
- Institut Universitaire du Cancer de Toulouse Oncopole
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Vandoeuvre-lès-Nancy, França, 54519
- Institut de Cancerologie de Lorraine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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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.
Prazo: Day 1 of the study
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Day 1 of the study
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
Prazo: Day 1 of the study
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Day 1 of the study
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Proportion of patients already followed-up by a palliative care team
Prazo: Day 1 of the study
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Day 1 of the study
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Mean score to questionnaire PALLIA-10
Prazo: Day 1 of the study
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Day 1 of the study
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Predictive factors of current palliative cares
Prazo: Day 1 of the study
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Day 1 of the study
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Prognostic factors of overall survival
Prazo: From Day 1 of the study to the update of survival status (6 months later)
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From Day 1 of the study to the update of survival status (6 months later)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gisèle CHVETZOFF, MD, Centre Leon Berard
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PREPA-10
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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