CancerMEGERIANCT02873533
Modification of the Quality of Life Based on Objective Geriatric Tests
A study testing geriatric care and longitudinal follow up in people with Cancer and Elderly Patients, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Elderly Patients
- What is being tested?
- geriatric care and longitudinal follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to 1 Apr 2019
- 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
- Patient over 70 years,
- Patient with a solid malignant tumor,
- Patients for whom a first line chemotherapy is theoretically indicated
- Patient chemotherapy naive,
- Performance Index (PS) <4
Who cannot join
- Patient not understanding or do not speak French,
- Patients with any severe psychopathological disorder preventing the completion of the questionnaire or invalidating a priori measures of the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Project - Prospective Longitudinal Cohort of Patients Over 70 Years With Malignant Solid Tumors: Modification of Quality of Life Based on Objective Geriatric Tests
The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment.
The analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.
Read the detailed description
Quality of life is defined as "an individual's perception of his place in life, in the context of culture and value system in which he lives, in relation to its goals, expectations, standards and concerns "(WHO 1993).
This concept refers to multiple dimensions, both objective and subjective:
- The physical condition of the person, his functional abilities;
- His somatic sensations;
- His psychological health;
- His social status, relational environment.
This concept focuses on perception's basics. Quality of life is a criteria supposed to be objective even though it is subject to subjective interpretation at the highest point. Indeed, if the quality of life varies depending on the discretion of each person, it also changes over time: it refers to a situation at a given moment and not to a stable state.
Therefore in this study, it seemed appropriate to show the concept of "quality of life objective" which is linked to objective data measures recognized criteria for evaluating the elderly. These criteria are repeatable, validated and not dependent operator.
This process completely matches with the actions promoted by the 2009-2013 Cancer Plan (measures 23 and 26) on the basis of an improvement of:
- The quality of consideration of the psychosocial dimension (customization accompaniment, living environment, social, involvement, ..)
- The quality of the integration of physical and psychological dangers inherent to this weakness situation induced by cancer.
- Conditions
- Cancer, Elderly Patients
- Being tested
- geriatric care and longitudinal follow up
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geriatric care and longitudinal follow upOther
geriatric care and longitudinal follow up
| Study group | Role | What they receive |
|---|---|---|
| A-Elderly patients with cancer | Other | geriatric care and longitudinal follow up Receives: Other: geriatric care and longitudinal follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring quality of life according to geriatric questionnaires
Activities of Daily Living Questionnaire
Measured: 36 months
Secondary outcomes (1)
Geriatric Screening Test fragilities and comorbidities
Mini Mental State Examination
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2013
- Primary completionMar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique MARI, md, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873533
- Sponsor's protocol ID
- 2011/11 MEGERIA
- Other IDs
- 2012-A01168-35
- Acronym
- MEGERIA
- Status last verified
- Jan 2018
- First submitted
- 11 Aug 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project - Prospective Longitudinal Cohort of Patients Over 70 Years With Malignant Solid Tumors: Modification of Quality of Life Based on Objective Geriatric Tests
- ClinicalTrials.gov ID
- NCT02873533
- Acronym / sponsor ID
- MEGERIA / 2011/11 MEGERIA
- Conditions
- Cancer, Elderly Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Aug 2016 (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.
The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment.
The analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.
Detailed description
Quality of life is defined as "an individual's perception of his place in life, in the context of culture and value system in which he lives, in relation to its goals, expectations, standards and concerns "(WHO 1993).
This concept refers to multiple dimensions, both objective and subjective:
- The physical condition of the person, his functional abilities;
- His somatic sensations;
- His psychological health;
- His social status, relational environment.
This concept focuses on perception's basics. Quality of life is a criteria supposed to be objective even though it is subject to subjective interpretation at the highest point. Indeed, if the quality of life varies depending on the discretion of each person, it also changes over time: it refers to a situation at a given moment and not to a stable state.
Therefore in this study, it seemed appropriate to show the concept of "quality of life objective" which is linked to objective data measures recognized criteria for evaluating the elderly. These criteria are repeatable, validated and not dependent operator.
This process completely matches with the actions promoted by the 2009-2013 Cancer Plan (measures 23 and 26) on the basis of an improvement of:
- The quality of consideration of the psychosocial dimension (customization accompaniment, living environment, social, involvement, ..)
- The quality of the integration of physical and psychological dangers inherent to this weakness situation induced by cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-Elderly patients with cancer | Other | Other: geriatric care and longitudinal follow upgeriatric care and longitudinal follow up |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient over 70 years,
- Patient with a solid malignant tumor,
- Patients for whom a first line chemotherapy is theoretically indicated
- Patient chemotherapy naive,
- Performance Index (PS) <4
Key exclusion criteria (2 listed)
- Patient not understanding or do not speak French,
- Patients with any severe psychopathological disorder preventing the completion of the questionnaire or invalidating a priori measures of the questionnaire
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 |
|---|---|---|
| geriatric care and longitudinal follow upgeriatric care and longitudinal follow up | Other | A-Elderly patients with cancer |
Primary outcome
Measuring quality of life according to geriatric questionnaires
Time frame: 36 months
Activities of Daily Living Questionnaire
1 secondary outcome
Geriatric Screening Test fragilities and comorbidities
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Véronique MARI, md principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geriatric care and longitudinal follow up in people with Cancer and Elderly Patients, run by Centre Antoine Lacassagne at 1 site 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 5 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: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring quality of life according to geriatric questionnaires (time frame: 36 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 30 Sep 2025.