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OpenTrials
Completed

NCT Number: NCT02873533

Modification of the 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.

Completed

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine LACASSAGNE

Nice, 06189, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geriatric care and longitudinal follow up

Other

geriatric care and longitudinal follow up

Primary outcomes

  1. Measuring quality of life according to geriatric questionnaires

    Time frame: 36 months

    Activities of Daily Living Questionnaire

Secondary outcomes

  1. Geriatric Screening Test fragilities and comorbidities

    Time frame: 36 months

    Mini Mental State Examination

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study 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

Acronym: MEGERIA

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2016
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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