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

NCT ID: NCT01188330

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia

Keywords

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acute myeloid leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

WITH Comprehensive Geriatric assessment

Intervention Type BEHAVIORAL

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

Conventional

Conventional haematological management of patients

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type BEHAVIORAL

no Comprehensive Geriatric assessment

Interventions

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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

Intervention Type BEHAVIORAL

Conventional

no Comprehensive Geriatric assessment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aude CHARBONNIER, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Aude CHARBONNIER, MD

Marseille, , France

Site Status RECRUITING

Christian RECHER

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique GENRE, MD

Role: CONTACT

Phone: (33) 4 91 22 37 78

Email: [email protected]

Agnès BOYER CHAMMARD, MD

Role: CONTACT

Phone: (33) 4 91 22 37 78

Email: [email protected]

Related Links

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http://www.institutpaolicalmettes.fr/

institut Paoli-Calmettes web site

Other Identifiers

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MLSP/IPC 2009-003

Identifier Type: -

Identifier Source: org_study_id