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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Oncology

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.

• Study Type: Observational
• Enrollment (Actual): 846

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Gisèle CHVETZOFF, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Prevalence; Palliative care; Observationnal study; Anti cancer center
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PREPA-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO