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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02479061
Other study ID # PREPA-10
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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