Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
MLSP
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
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedOctober 31, 2013
October 1, 2013
6.5 years
August 24, 2010
October 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
nutritional status
6 months
quality of life
6 months
survival
6 months
Study Arms (2)
WITH Comprehensive Geriatric assessment
EXPERIMENTALConventional 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
ACTIVE COMPARATORConventional haematological management of patients
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 Criteria
You may qualify if:
- Patients aged 70 years and older
- Referred for treatment following a diagnosis of acute myeloid leukaemia.
- signed informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aude CHARBONNIER, MD
Marseille, 13009, France
Christian RECHER
Toulouse, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aude CHARBONNIER, MD
Institut Paoli-Calmettes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2010
First Posted
August 25, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2016
Last Updated
October 31, 2013
Record last verified: 2013-10