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

Neoplasms Clinical Trial

— PREPA-10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479061
• Other study ID #: PREPA-10
• Status: Completed
• Phase: N/A
• First received: June 19, 2015
• Last updated: August 16, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: June 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	Centre Jean PERRIN	Clermont Ferrand
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmettes	Marseille
France	Institut Régional du Cancer de Montpellier	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut Curie	Paris - Saint Cloud
France	Institut Jean GODINOT	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Paul Strauss	Strasbourg
France	Institut Universitaire du Cancer de Toulouse Oncopole	Toulouse
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 1 of the study
Secondary	The proportion of patients with a score greater than 5 to questionnaire PALLIA-10		Day 1 of the study
Secondary	Proportion of patients already followed-up by a palliative care team		Day 1 of the study
Secondary	Mean score to questionnaire PALLIA-10		Day 1 of the study
Secondary	Predictive factors of current palliative cares		Day 1 of the study
Secondary	Prognostic factors of overall survival		From Day 1 of the study to the update of survival status (6 months later)