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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

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 25, 2010
Last Update Posted Date October 31, 2013
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
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 (OARS), Instrumental Activities of Daily Living (IADL) mesured at diagnosis and 6 month after inclusion.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • nutritional status [ Time Frame: 6 months ]
    mesured by the mini MNA
  • quality of life [ Time Frame: 6 months ]
    estimated by QLQ-C30
  • survival [ Time Frame: 6 months ]
    overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • 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

  • Behavioral: Conventional
    no Comprehensive Geriatric assessment
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: WITH Comprehensive Geriatric assessment
  • Active Comparator: Conventional
    Conventional haematological management of patients
    Intervention: Behavioral: Conventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 24, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188330
Other Study ID Numbers  ICMJE MLSP/IPC 2009-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aude CHARBONNIER, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP