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

Acute Myeloid Leukemia Clinical Trial

— MLSP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01188330
• Other study ID #: MLSP/IPC 2009-003
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2010
• Last updated: October 30, 2013
• Start date: March 2010

Study information

• Verified date: October 2013
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: (33) 4 91 22 37 78
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• WITH 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
• Conventional
no Comprehensive Geriatric assessment

Locations

Country	Name	City	State
France	Aude CHARBONNIER, MD	Marseille
France	Christian RECHER	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	nutritional status	mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)	6 months	No
Secondary	quality of life	estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)	6 months	No
Secondary	survival	overall survival	6 months	No

External Links

•   institut Paoli-Calmettes web site