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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Behavioral: WITH Comprehensive Geriatric assessment Behavioral: Conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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


Arm Intervention/treatment
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
Behavioral: Conventional
no Comprehensive Geriatric assessment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. nutritional status [ Time Frame: 6 months ]
    mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)

  2. quality of life [ Time Frame: 6 months ]
    estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)

  3. survival [ Time Frame: 6 months ]
    overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Dominique GENRE, MD (33) 4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD (33) 4 91 22 37 78 drci.up@ipc.unicancer.fr

Locations
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France
Aude CHARBONNIER, MD Recruiting
Marseille, France, 13009
Christian RECHER Recruiting
Toulouse, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Aude CHARBONNIER, MD Institut Paoli-Calmettes
Additional Information:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01188330    
Other Study ID Numbers: MLSP/IPC 2009-003
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013
Keywords provided by Institut Paoli-Calmettes:
acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms