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Trial Title:
Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
NCT ID:
NCT01188330
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
acute myeloid leukemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
WITH Comprehensive Geriatric assessment
Description:
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
Arm group label:
WITH Comprehensive Geriatric assessment
Intervention type:
Behavioral
Intervention name:
Conventional
Description:
no Comprehensive Geriatric assessment
Arm group label:
Conventional
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aude CHARBONNIER, MD
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Facility:
Name:
Christian RECHER
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Start date:
March 2010
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01188330
http://www.institutpaolicalmettes.fr/
