Clinical trial NCT02479061: An Observational Study of the Prevalence of Patients Requiring Palliative Care in French Anti-cancer Centers.
Official title: An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Oncology
Keywords: Observationnal study
Prevalence
Palliative care
Anti cancer center
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients hospitalized in a conventionnal medical service of a French anti cancer center.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 1 of the study
Secondary outcomes:
measure: The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
timeFrame: Day 1 of the study
measure: Proportion of patients already followed-up by a palliative care team
timeFrame: Day 1 of the study
measure: Mean score to questionnaire PALLIA-10
timeFrame: Day 1 of the study
measure: Predictive factors of current palliative cares
timeFrame: Day 1 of the study
measure: Prognostic factors of overall survival
timeFrame: From Day 1 of the study to the update of survival status (6 months later)
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean PERRIN
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris - Saint Cloud
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean GODINOT
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse Oncopole
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Centre Leon Berard
name: Gisele CHVETZOFF, MD
role: PRINCIPAL_INVESTIGATOR
References: