Modification of the Quality of Life Based on Objective Geriatric Tests (MEGERIA)

September 29, 2025 updated by: Centre Antoine Lacassagne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A-Elderly patients with cancer
geriatric care and longitudinal follow up
Other: geriatric care and longitudinal follow up
geriatric care and longitudinal follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring quality of life according to geriatric questionnaires
Time Frame: 36 months
Activities of Daily Living Questionnaire
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriatric Screening Test fragilities and comorbidities
Time Frame: 36 months
Mini Mental State Examination
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Investigators

  • Principal Investigator: Véronique MARI, md, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 19, 2016

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/11 MEGERIA
  • 2012-A01168-35 (Other Identifier: ANSM ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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