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Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival (MLSP)

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WITH Comprehensive Geriatric assessment
Conventional
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aude CHARBONNIER, MDRecruiting
  • Christian RECHERRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WITH Comprehensive Geriatric assessment

Conventional

Arm Description

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.

Conventional haematological management of patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

nutritional status
mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)
quality of life
estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)
survival
overall survival

Full Information

First Posted
August 24, 2010
Last Updated
October 30, 2013
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT01188330
Brief Title
Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
Acronym
MLSP
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WITH Comprehensive Geriatric assessment
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional haematological management of patients
Intervention Type
Behavioral
Intervention Name(s)
WITH Comprehensive Geriatric assessment
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Conventional
Intervention Description
no Comprehensive Geriatric assessment
Primary Outcome Measure Information:
Title
functional status
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
nutritional status
Description
mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)
Time Frame
6 months
Title
quality of life
Description
estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)
Time Frame
6 months
Title
survival
Description
overall survival
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
(33) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès BOYER CHAMMARD, MD
Phone
(33) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aude CHARBONNIER, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aude CHARBONNIER, MD
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Name
Christian RECHER
City
Toulouse
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr/
Description
institut Paoli-Calmettes web site

Learn more about this trial

Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival

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