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

Institut Paoli-Calmettes

Status: Unknown

Conditions: Acute Myeloid Leukemia

Treatments: Behavioral: Conventional; Behavioral: WITH Comprehensive Geriatric assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01188330

MLSP/IPC 2009-003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

WITH Comprehensive Geriatric assessment

Experimental group

Description:

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.

Treatment:

Behavioral: WITH Comprehensive Geriatric assessment

Conventional

Active Comparator group

Description:

Conventional haematological management of patients

Treatment:

Behavioral: Conventional