NeoplasmsPREPA-10NCT02479061
An Observational Study of the Prevalence of Patients Requiring Palliative Care in French Anti-cancer Centers.
An observational study of Neoplasms and Oncology, run by Centre Leon Berard at 15 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 846 participants
- Where
- 15 sitesFrance
- Study dates
- Jun 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in a conventionnal medical service of a French anti cancer center.
Who may be able to join
- 18-year old or older
- Hospitalized in a conventionnal medical service, including radiotherapy, brachytherapy, palliative care units.
Who cannot join
- Patient hospitalized in an out-patient service, surgery unit, weekly units
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Institut de Cancérologie de l'Ouest
Angers, 49933
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14000
Centre Jean PERRIN
Clermont-Ferrand, 63011
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13009
Institut Régional du Cancer de Montpellier
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris - Saint Cloud, 75005
Institut Jean GODINOT
Reims, 51726
Centre Eugène Marquis
Rennes, 35000
Centre Paul Strauss
Strasbourg, 67085
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- Observationnal study, Prevalence, Palliative care, Anti cancer center
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 of the study
Secondary outcomes (5)
The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
Measured: Day 1 of the study
Proportion of patients already followed-up by a palliative care team
Measured: Day 1 of the study
Mean score to questionnaire PALLIA-10
Measured: Day 1 of the study
Predictive factors of current palliative cares
Measured: Day 1 of the study
Prognostic factors of overall survival
Measured: From Day 1 of the study to the update of survival status (6 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisele CHVETZOFF, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479061
- Sponsor's protocol ID
- PREPA-10
- Acronym
- PREPA-10
- Status last verified
- Aug 2017
- First submitted
- 19 Jun 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.
- ClinicalTrials.gov ID
- NCT02479061
- Acronym / sponsor ID
- PREPA-10 / PREPA-10
- Keywords
- Observationnal study, Prevalence, Palliative care, Anti cancer center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in a conventionnal medical service of a French anti cancer center.
Key inclusion criteria (2 listed)
- 18-year old or older
- Hospitalized in a conventionnal medical service, including radiotherapy, brachytherapy, palliative care units.
Key exclusion criteria (1 listed)
- Patient hospitalized in an out-patient service, surgery unit, weekly units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Day 1 of the study
5 secondary outcomes
The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
Time frame: Day 1 of the study
Proportion of patients already followed-up by a palliative care team
Time frame: Day 1 of the study
Mean score to questionnaire PALLIA-10
Time frame: Day 1 of the study
Predictive factors of current palliative cares
Time frame: Day 1 of the study
Prognostic factors of overall survival
Time frame: From Day 1 of the study to the update of survival status (6 months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisele CHVETZOFF, MD principal investigator
Centre Leon Berard
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Oncology, run by Centre Leon Berard at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 1 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.