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

Institut Paoli-Calmettes100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Acute Myeloid Leukemia

Interventions

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

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

nutritional status

mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)

Time frame: 6 months

quality of life

estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)

Time frame: 6 months

survival

overall survival

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts