Elderly Cancer Patient: ELCAPA Cohort Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
研究概览
简要总结
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.
Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.
The objectives are:
- To assess the role of GA for decision making process for older patients with cancer
- To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities
- To develop and/or validate screening tests for frailty in geriatric oncology
- To develop and validate frailty classifications
Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient aged 70 years or older
- •Diagnosed cancer at all stage
- •Referred to a geriatrician for GA
- •Given oral non-opposition from patient or a legally mandated person
排除标准
- •Oral opposition
结局指标
主要结局
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
时间窗: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).
次要结局
- Overall mortality(Year 1 and 5 years follow-up)
- Chemotherapy toxicities using Common Terminology Criteria for Adverse Events(through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).)
- Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)(through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).)