Retrospective Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 117
- 试验地点
- 15
- 主要终点
- The score of activities of daily living on th Geriatric Assessment in Haematology (GAH) scale
研究概览
简要总结
This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric properties of the GAH study (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be collected to ensure its retrospective nature, thereby reflecting routine clinical practice and non-interference in the physician's clinical practice
详细描述
Patients over 65 are the most prevalent population in oncological clinical practice. It is also expected that this group of patients will increase significantly in the coming decades as a result of increased life expectancy and the aging population.
Overall, the population is aging and this aging is accompanied by an increase in the prevalence and incidence of age-related diseases, such as cancer. So much so that approximately 60% of new cancer cases and 70% of the overall cancer mortality occurs in patients aged 65 and over.
Despite the high incidence of cancer in the elderly and its peculiarities as opposed to young patients, from the point of view of health, the management of elderly patients is especially complex because there are few data on the evaluation and treatment thereof. Often, older patients are underrepresented in clinical trials and treatment guidelines, resulting in a population that is undertreated or at greater risk of suffering treatment-related toxicities.
In this respect, both the National Comprehensive Cancer Network (NCCN) and the International Society of Geriatric Oncology (SIOG, its acronym in Spanish) agree that age should not be an impediment to treat these diseases. Optimal management requires strategies specifically directed to the clinical and biological characteristics of this type of patient and they recommend an appropriate assessment of the patient as part of a safe and effective approach to haematological malignancies in the elderly.
There is scientific basis supporting the need for the elderly patient with cancer who will receive a particular treatment to be specifically assessed by means of a comprehensive geriatric assessment (CGA). Geriatric assessment is essential since it is a tool that integrates all aspects of the patient's life that could affect the course of the disease and response to treatment, such as functional status, comorbidities, cognitive, emotional or nutritional status and social environment. In addition, the CGA is a tool to identify the possible presence of fragility, characterized by a decrease in physiological reserves that conditions a lower response to stress and is associated with a lower risk of disability and increased morbidity and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were participating in the GAH study (CEL-GAH-2011-01).
- •Patients who have been scheduled to start treatment at a date less than three months after completion of the GAH (CEL-GAH-2011-01) scale in one of these visits: baseline, test-retest or sensitivity to change.
- •Patients who give informed consent to participate in the study as long as such consent is possible.
排除标准
- •Not applicable
结局指标
主要结局
The score of activities of daily living on th Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
Assessment of so-called basic activities of daily living (ADLs), including the skills necessary for life such as dressing, grooming, bathing and feeding
The score of nutrition on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
To determine nutritional deficit
The time of gait velocity on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
To determine the time taken to walk four meters at a normal pace.
The score of subjective health status on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
The patient rating his or her own health
Assessment of the tolerability of the treatment administered
时间窗: Up to approximately 4 months
Number of patients, which suspend or modify treatment due to toxicity
The score of mental State on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
To evaluate mental state
The score of comorbidity on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
Six variables of comorbidity and habits were considered (diabetes mellitus, cancer, lung disease, heart failure, smoking)
The score of number of drugs on the Geriatric Assessment in Haematology (GAH) scale
时间窗: Up to approximately 4 months
Determination of number of drugs that patients were taken.
次要结局
- Percentage of patients with toxicity(Up to approximately 4 months)
- Therapeutic approach according to clinical judgment(Up to approximately 4 months)
- Discontinuation of the planned treatment due to toxicity(Up to approximately 4 months)
- Modification of the planned treatment regimen due to toxicity(Up to approximately 4 months)
- Number of participants visit to hospital as a result of toxicity(Up to approximately 4 months)