Clinical trial NCT02873533: Modification of the Quality of Life Based on Objective Geriatric Tests
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Elderly Patients
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 76
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring quality of life according to geriatric questionnaires
timeFrame: 36 months
Secondary outcomes:
measure: Geriatric Screening Test fragilities and comorbidities
timeFrame: 36 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
Study officials:
affiliation: Centre Antoine Lacassagne
name: Véronique MARI, md
role: PRINCIPAL_INVESTIGATOR
References: