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
70 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
functional status
Outcome Description:
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.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Aude CHARBONNIER, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Paoli-Calmettes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
MLSP/IPC 2009-003
NCT ID:
NCT01188330
Start Date:
March 2010
Completion Date:
Related Keywords:
- Acute Myeloid Leukemia
- acute myeloid leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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