Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival (MLSP)
Randomized Study Comparing the Interest of a Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival of Elderly Patients With Acute Myeloid Leukaemia. MLSP/IPC 2009-003
Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of 65. A poor outcome in this population has been well established, with very short overall survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors related to the disease itself or to the patient's medical condition.
This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed at diagnosis with planned interventions according to disabilities and monthly follow-up by a nurse practitioner during 6 months on functional status of older cancer patients treated for Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Marseille, 프랑스, 13009
- 모병
- Aude CHARBONNIER, MD
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Toulouse, 프랑스
- 모병
- Christian RECHER
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients aged 70 years and older
- Referred for treatment following a diagnosis of acute myeloid leukaemia.
- signed informed consent
Exclusion Criteria:
- Terminal patients, with a life expectancy estimated to be less than 3 months, will be excluded from the study, due to ethical issues and the fact that they are unlikely to benefit from this evaluation.
- Patients unable to give informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: WITH Comprehensive Geriatric assessment
Conventional haematological management of patients and Comprehensive Geriatric assessment (CGA) at diagnosis followed by interventions according to disabilities detected and planned monthly follow up by a nurse practitioner during 6 months.
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Each month after randomization, a nurse practitioner will systematically review the intervention plan. In case of hospitalisation, the nurse will go and meet the patient and his care giver to check each point of the intervention plan. If an action has not been done, a new proposal will be made to the patient. If the patient is at home or in institution, the nurse practitioner will call the patient and /or his care giver for the same purpose |
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활성 비교기: Conventional
Conventional haematological management of patients
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no Comprehensive Geriatric assessment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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functional status
기간: 6 months
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The functional status is evaluated with KATZ INDEX : BASIC ACTIVITIES OF DAILY LIVING (ADL) and Older American Resources and Services, Instrumental Activities of Daily Living (IADL) mesured at diagnosis and 6 month after inclusion.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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nutritional status
기간: 6 months
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mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)
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6 months
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quality of life
기간: 6 months
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estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)
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6 months
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survival
기간: 6 months
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overall survival
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aude CHARBONNIER, MD, Institut Paoli-Calmettes
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MLSP/IPC 2009-003
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