Modification of the Quality of Life Based on Objective Geriatric Tests

Cancer Clinical Trial

— MEGERIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873533
• Other study ID #: 2011/11 MEGERIA
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2018
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 1, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Elderly Patients

Intervention

Other:
• geriatric care and longitudinal follow up
geriatric care and longitudinal follow up

Locations

Country	Name	City	State
France	Centre Antoine LACASSAGNE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring quality of life according to geriatric questionnaires	Activities of Daily Living Questionnaire	36 months
Secondary	Geriatric Screening Test fragilities and comorbidities	Mini Mental State Examination	36 months