Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •G8 score ≤
- •WHO score ≤2
- •Having an ADL score ≥ 4 (Katz scale).
- •Having an MMSE score > 24
- •At risk of social isolation: m-MOS below 80%, and / or the following criteria: patient living alone without close help (<50 km) and / or primary caregiver of the patient's spouse, spouse limited autonomy and / or reached itself a disease (neurodegenerative disease, cancer disease, other) requiring regular hospital treatment for at least 3 months.
- •Locally advanced or metastatic cancer or malignant blood disease (except acute leukemia)
- •Treated by chemotherapy, new generation hormone therapy, immunotherapy or targeted therapy in first or second line of treatment, with or without radiotherapy
- •Life expectancy more than 6 months
- •Informed consent signed.
- •Patients affiliated to French social security system in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health)
排除标准
- •Patients with other cancers
- •Patients should be directed immediately into a rehabilitation and recuperative care service to receive treatment or in a palliative care service
- •Inability to sign a consent or under guardianship
研究组 & 干预措施
Interventional arm PS-DR
The interventional arm (PS-DR) will include the implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance (in connection with a call center 24h/24).
干预措施: Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (Other)
Reference Arm
In the reference arm, patients will have a conventional oncological care, social support measures will be left to the discretion of the clinician and the paramedical team.
结局指标
主要结局
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
时间窗: 3 months
The "global health" score will constitute the main judgment criteria
次要结局
- Time to failure of first line of treatment(From date of inclusion until treatment failure, up to 6 months)
- Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale(3 months and 6 months)
- Nutritional assessment at 3 months and 6 months(3 months and 6 months)
- Social isolation(12 months)
- First line of treatment toxicity at the end(12 months)
- Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies(12 months)
- Measure of the "global health score" to assess the quality of life at first line of treatment(3 months and 6 months)
- Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale(3 months and 6 months)
- Functional assessment at 3 months and 6 months(3 months and 6 months)
- Overall Survival defined as the time between chemotherapy start and death(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.(up to 12 months)