- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02479061
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Angers, 프랑스, 49933
- Institut de cancérologie de l'ouest
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Bordeaux, 프랑스, 33076
- Institut Bergonié
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Caen, 프랑스, 14000
- Centre Francois Baclesse
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Clermont Ferrand, 프랑스, 63011
- Centre Jean Perrin
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Lille, 프랑스, 59020
- Centre Oscar Lambret
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Lyon, 프랑스, 69008
- Centre Leon Berard
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Marseille, 프랑스, 13009
- Institut Paoli Calmettes
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Montpellier, 프랑스, 34298
- Institut Régional du Cancer de Montpellier
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Paris - Saint Cloud, 프랑스, 75005
- Institut Curie
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Reims, 프랑스, 51726
- Institut Jean Godinot
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Rennes, 프랑스, 35000
- Centre Eugene Marquis
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Strasbourg, 프랑스, 67085
- Centre Paul Strauss
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Toulouse, 프랑스, 31059
- Institut Universitaire du Cancer de Toulouse Oncopole
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Vandoeuvre-lès-Nancy, 프랑스, 54519
- Institut de Cancerologie de Lorraine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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.
기간: Day 1 of the study
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Day 1 of the study
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The proportion of patients with a score greater than 5 to questionnaire PALLIA-10
기간: Day 1 of the study
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Day 1 of the study
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Proportion of patients already followed-up by a palliative care team
기간: Day 1 of the study
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Day 1 of the study
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Mean score to questionnaire PALLIA-10
기간: Day 1 of the study
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Day 1 of the study
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Predictive factors of current palliative cares
기간: Day 1 of the study
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Day 1 of the study
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Prognostic factors of overall survival
기간: From Day 1 of the study to the update of survival status (6 months later)
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From Day 1 of the study to the update of survival status (6 months later)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gisèle CHVETZOFF, MD, Centre Leon Berard
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
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