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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01188330

Acronym

MLSP

Enrollment

100

Registered

2010-08-25

Start date

2010-03-31

Completion date

Unknown

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia

Brief summary

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.

Interventions

BEHAVIORALWITH Comprehensive Geriatric assessment

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

BEHAVIORALConventional

no Comprehensive Geriatric assessment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
functional status	6 months	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.

Secondary

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

Countries

France

Contacts

Primary ContactDominique GENRE, MD

drci.up@ipc.unicancer.fr(33) 4 91 22 37 78

Backup ContactAgnès BOYER CHAMMARD, MD