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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02873533
Other study ID # 2011/11 MEGERIA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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