Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

16 de agosto de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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 estudio

De observación

Inscripción (Actual)

846

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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.
Periodo de tiempo: Day 1 of the study
Day 1 of the study

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
Periodo de tiempo: Day 1 of the study
Day 1 of the study
Proportion of patients already followed-up by a palliative care team
Periodo de tiempo: Day 1 of the study
Day 1 of the study
Mean score to questionnaire PALLIA-10
Periodo de tiempo: Day 1 of the study
Day 1 of the study
Predictive factors of current palliative cares
Periodo de tiempo: Day 1 of the study
Day 1 of the study
Prognostic factors of overall survival
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Gisèle CHVETZOFF, MD, Centre Leon Berard

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2015

Finalización primaria (Actual)

1 de marzo de 2016

Finalización del estudio (Actual)

1 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

19 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de junio de 2015

Publicado por primera vez (Estimar)

23 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

16 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PREPA-10

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

3
Suscribir