Exploratory Study of Frailty Evaluation in Elderly Population With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The Comprehensive Geriatric Assessment (CGA) is, still today, barely established in the standard practice. Although the different scientific societies recommend a CGA in elderly population affected with cancer at first visit, the evidence regarding its transcendence is limited. On the other hand, the components of this evaluation and the translation of their findings in changes in the clinical practice are not stablished. This project intends to implement a CGA in a group of patients to compare this group with an historical cohort that reflects the standard practice, to evaluate the differences between both approaches. The study also evaluate the feasibility and utility of this CGA. All these questions aims to support the hypothesis that CGA impacts on the cancer treatment for elderly population affected with cancer.
详细描述
This study compares two groups of elderly patients affected with stage IV non-small lung cancer (NSCLC), stage III colon cancer and stage IV colorectal cancer (CRC): a prospective experimental cohort and an historic control cohort. The sample size is 60 patients, 30 prospective and 30 retrospective. Of each cohort, 10 patients have stage IV NSCLC, 10 have stage III colon cancer and 10 have stage IV CRC. Prospective patients will be recruited longitudinally from January 2013 and retrospective patients are recorded longitudinally backward in time from December 2012. Both groups are patients of Medical Oncology Service of Hospital General Universitario de Elche, and both groups sign an informed consent form.
A CGA is performed in the experimental group after the first visit with oncologist and prior to therapeutic decision. This CGA includes:
- Nutritional Assessment: Mini Nutritional Assessment (MNA)
- Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss.
- Cognitive Assessment: Mini-Mental State Examination (MMSE-30)
- Psychological status: Geriatric Depression Scale (GDS)
- Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS)
- Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27)
The evaluation includes too age, haemoglobin, Creatinine Clearance (CrCl) and presence of geriatric syndromes.
The results of this evaluation allow to calculate:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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 more than 70 years
- •Outpatients
- •Patients diagnosed with stage III colon cancer, stage IV colorectal cancer or stage IV NSCLC
- •No previous diagnosis of cancer.
- •No previous chemotherapy for current diagnosis of cancer
- •Signed informed consent
排除标准
- •Not fulfilling inclusion criteria
结局指标
主要结局
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
Evaluate occurrence of toxicity in both groups, experimental and control
次要结局
- Number of participants with occurrence of early mortality(6 months)
- Number of Hospitalizations(6 months)
- Number of participants with changes in cancer treatment related to toxicity(6 months)
- Number of participants with a change in therapeutic decision related to CGA(6 months)
- Contribution of different components of CGA to the management fo cancer(6 months)
- Impact of CGA in health care in terms of human recourses and time consumption(Baseline)
- Predictive factors of events related to treatment(6 months)
研究者
Javier Gallego Plazas
PhD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana