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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WITH Comprehensive Geriatric assessment | Experimental | 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. |
|
| Conventional | Active Comparator | Conventional haematological management of patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WITH Comprehensive Geriatric assessment | Behavioral | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique GENRE, MD | Contact | (33) 4 91 22 37 78 | drci.up@ipc.unicancer.fr | |
| Agnès BOYER CHAMMARD, MD | Contact | (33) 4 91 22 37 78 | drci.up@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aude CHARBONNIER, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aude CHARBONNIER, MD | Recruiting | Marseille | 13009 | France | ||
| Christian RECHER |
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| Label | URL |
|---|---|
| institut Paoli-Calmettes web site | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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|
| Conventional | Behavioral | no Comprehensive Geriatric assessment |
|
| 6 months |
| survival | overall survival | 6 months |
| Recruiting |
| Toulouse |
| France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |