Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Behavioral: WITH Comprehensive Geriatric assessment
* Behavioral: Conventional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WITH Comprehensive Geriatric assessment<br>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. | Behavioral: WITH Comprehensive Geriatric assessment<br>* 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<br>|
| Active Comparator: Conventional<br>Conventional haematological management of patients | Behavioral: Conventional<br>* no Comprehensive Geriatric assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional status | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional status | mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF) | 6 months | 
| quality of life | estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30) | 6 months | 
| survival | overall survival | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia