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

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: Cancer; Elderly Patients
• Intervention / Treatment: Other: geriatric care and longitudinal follow up

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Activities of Daily Living Questionnaire	36 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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 (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2011/11 MEGERIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED