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

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Behavioral: WITH Comprehensive Geriatric assessment; Behavioral: Conventional

• Registration Number: NCT01188330
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WITH Comprehensive Geriatric assessment	WITH Comprehensive Geriatric assessment	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	Conventional	Conventional haematological management of patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Aude CHARBONNIER, MD; 🇫🇷 Marseille, France

Christian RECHER; 🇫🇷 Toulouse, France