Expression of a Need of Implication for the Vulnerable Patient and His Adaptation (EIVA)
연구 개요
상태
상태
정황
정황
상세 설명
The respect for the rights of the patients in palliative phase - having an evolutionary or terminal grave pathology - is a legal requirement since 1999, strengthened by the laws of April 4th, 2002 and April 22nd, 2005. Nevertheless, a lack of palliative approach persists, that is premature awareness of the necessity of a global approach, not exclusively centred on the specific therapeutics. The palliative approach remains rare and especially most of the time reduced in the last days of the life. The lack of distribution of the legal texts and insufficient training are among the main reasons. The lack of educational tools is probably also a major brake in a premature reflection.
Primary objective : to detect prematurely vulnerable patients needing a global coverage in integrated care with a created and metrological validated score.
Primary endpoint: capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach
Secondary objectives:
- The measure of the relevance of the tests of quality of life, personality traits, level of information and anxiety depression to detect prematurely the vulnerable patients and/or their family caregivers who need an approach of palliative care in integrated care;
- The detail (date, nature of the event) of the various stages of their life course, during which the vulnerable patients needing a premature global care were taken care within the framework of such an approach, compared with their theoretical detection by the score of premature detection scale;
- The evaluation of the concordance between the patient score and the family caregiver score, if he participates in the research.
Secondary endpoints:
- The tests estimating the anxiety and the depression ( HAD (Hospital Anxiety and Depression) score), the personality and adaptation traits, Brief Cope;
- The quality of life tests EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) and level of information EORTC INF-30 (Information-30) for the cancer patients;
- The deadline between detection by the score and effective global care
- The deadline between detection by the score and the cessation of the specific treatments
- The deadline between detection by the score and the death
- The patient and close scores obtained in the validation phase.
Methods: Prospective, controlled, nonrandomized study
Number of patients to include: 610 (maximum)
Duration: 36 months (32 inclusion months).
Number of participating centers: 1 center
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Suresnes, 프랑스, 92150
- Hôpital Foch
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
All patients hospitalized with:
- an evolutionary incurable disease;
- Taken care for more than a month by the health care team palliatives EIVA (except for the last 200 patients, for whom the deadline extension of palliative care is lower that 6 days);
- Benefiting of asocial scheme or claimant
- Having signed the informed consent as well as his(her) family caregiver, if this one participates in the research.
The absence of family caregiver is not an exclusion criterion.
Exclusion Criteria:
Patient:
- Having difficulty of understanding of the French language
- Having a life expectancy estimated unless one month
- un controlled physical or psychic distress (anxiety and/or depression)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Group A
Elaboration of the questionnaires
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실험적: Group B
Patients taken care for more less than 6 days by the health care team palliatives EIVA and they eventual family caregiver.
Score
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Capacity of the score to be discriminated (area under the curve) to find the patients who need or not a palliative approach
기간: 15 days
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15 days
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Edouard FERRAND, MD, Hôpital Foch
간행물 및 유용한 링크
일반 간행물
- Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
- Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Arraras JI, Greimel E, Sezer O, Chie WC, Bergenmar M, Costantini A, Young T, Vlasic KK, Velikova G. An international validation study of the EORTC QLQ-INFO25 questionnaire: an instrument to assess the information given to cancer patients. Eur J Cancer. 2010 Oct;46(15):2726-38. doi: 10.1016/j.ejca.2010.06.118. Epub 2010 Jul 30.
- Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.
- Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.
- Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 2014/27
- 2014-A01386-41 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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