Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival (MLSP)
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|ClinicalTrials.gov Identifier: NCT01188330|
Recruitment Status : Unknown
Verified October 2013 by Institut Paoli-Calmettes.
Recruitment status was: Recruiting
First Posted : August 25, 2010
Last Update Posted : October 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Behavioral: WITH Comprehensive Geriatric assessment Behavioral: Conventional||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||September 2016|
Experimental: 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.
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
Active Comparator: Conventional
Conventional haematological management of patients
no Comprehensive Geriatric assessment
- functional status [ Time Frame: 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.
- nutritional status [ Time Frame: 6 months ]mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)
- quality of life [ Time Frame: 6 months ]estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)
- survival [ Time Frame: 6 months ]overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188330
|Contact: Dominique GENRE, MD||(33) 4 91 22 37 firstname.lastname@example.org|
|Contact: Agnès BOYER CHAMMARD, MD||(33) 4 91 22 37 email@example.com|
|Aude CHARBONNIER, MD||Recruiting|
|Marseille, France, 13009|
|Principal Investigator:||Aude CHARBONNIER, MD||Institut Paoli-Calmettes|