The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.
In France, social isolation and prevalence of cancer increases with the population ageing: it is estimated that in 2050, 1 of 2 cancers will be diagnosed in patients over than 75 years old. Meanwhile, the share of isolated elderly increased from 16 to 24% between 2010 and 2013. It is shown that socially precarious elderly have an increased risk of dying from cancer. Among the areas of Comprehensive Geriatric Assessment (CGA), social assessment is crucial. It can be assessed by a self-administered 8 items questionnaire, derived from MOS-SS (Medical Outcomes Study Social Support Survey) and validated in the elderly supported for cancer: m-MOS-SS (modified Medical Outcomes Study Social Support). Once spotted, social isolation can be averted by appropriate measures, provided the intervention of a multidisciplinary team. In this area, the techniques of automation and remote assistance might have an interest. They already demonstrated their impact on falls prevention, addiction, feelings of social isolation and quality of life. However, little is known about the impact of social isolation in elderly patients supported for cancer. The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
320
Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
Assistance Publique Hôpitaux de Marseille
Marseille, France
RECRUITINGMeasure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
The "global health" score will constitute the main judgment criteria
Time frame: 3 months
Time to failure of first line of treatment
Time between inclusion and treatment failure, whatever the cause
Time frame: From date of inclusion until treatment failure, up to 6 months
First line of treatment toxicity at the end
Measured by Toxicity scale NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events, version 4.0).
Time frame: 12 months
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Treatment compliance
Time frame: 12 months
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Time frame: 3 months and 6 months
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Time frame: 3 months and 6 months
Nutritional assessment at 3 months and 6 months
Body mass index (BMI) is the ratio of weight to height in cm squared.
Time frame: 3 months and 6 months
Functional assessment at 3 months and 6 months
The unipodal station is to stand on one foot without aid. A unipodal station less than 5 seconds indicating a high risk of falls (46).
Time frame: 3 months and 6 months
Overall Survival defined as the time between chemotherapy start and death
will be assessed at 6 months and 1 year
Time frame: up to 12 months
Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
Time to progression is the time elapsed between the date of treatment start and the occurrence of progression or relapse if a response was observed (response or stabilization). A patient who has not progressed or who did not die at the limit of 1 year will have its censored survival time when tumor enough last evaluation conducted by the deadline of 1 year . The progress will then be defined according to the criteria RECIST1.1 . In case of death , it will be identified if it is related to tumor progression , toxicity or complication of treatment or another cause (non-specific death).
Time frame: up to 12 months
Social isolation
Social isolation will be measured by the m -MOS questionnaire. A result \< 80% is recognized as the consensus inferior value below which patients are socially isolated position
Time frame: 12 months
Measure of the "global health score" to assess the quality of life at first line of treatment
Time frame: 3 months and 6 months
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