Acute Myeloid LeukemiaMLSPNCT01188330
Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival
A study testing WITH Comprehensive Geriatric assessment and Conventional in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- WITH Comprehensive Geriatric assessment and Conventional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 70 years and older
- Referred for treatment following a diagnosis of acute myeloid leukaemia.
- signed informed consent
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Aude CHARBONNIER, MD
Marseille, 13009
- Recruiting
Christian RECHER
Toulouse
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- WITH Comprehensive Geriatric assessment, Conventional
- Keywords
- acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WITH Comprehensive Geriatric assessmentBehavioural
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
ConventionalBehavioural
no Comprehensive Geriatric assessment
| Study group | Role | What they receive |
|---|---|---|
| WITH Comprehensive Geriatric assessment | Experimental | 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. Receives: Behavioral: WITH Comprehensive Geriatric assessment |
| Conventional | Active comparator | Conventional haematological management of patients Receives: Behavioral: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
nutritional status
mesured by the Mini Nutritional Assessment Short Form (mini MNA-SF)
Measured: 6 months
quality of life
estimated by a Quality of Life Questionnaire including 30 items (QLQ-C30)
Measured: 6 months
survival
overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aude CHARBONNIER, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188330
- Sponsor's protocol ID
- MLSP/IPC 2009-003
- Acronym
- MLSP
- Status last verified
- Oct 2013
- First submitted
- 24 Aug 2010
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01188330
- Acronym / sponsor ID
- MLSP / MLSP/IPC 2009-003
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2016 (estimated)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WITH Comprehensive Geriatric assessment | Experimental | Behavioral: WITH Comprehensive Geriatric assessmentConventional 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 | Active comparator | Behavioral: ConventionalConventional haematological management of patients |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 70 years and older
- Referred for treatment following a diagnosis of acute myeloid leukaemia.
- signed informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WITH Comprehensive Geriatric assessmentEach 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 | Behavioural | WITH Comprehensive Geriatric assessment |
| Conventionalno Comprehensive Geriatric assessment | Behavioural | Conventional |
Primary outcome
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.
3 secondary outcomes
nutritional status
Time frame: 6 months
quality of life
Time frame: 6 months
survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- institut Paoli-Calmettes web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aude CHARBONNIER, MD principal investigator
Institut Paoli-Calmettes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WITH Comprehensive Geriatric assessment and Conventional in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD ((33) 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.