Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
研究概览
简要总结
RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.
详细描述
OBJECTIVES:
- To assess the feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.
- To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).
- To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.
- To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.
OUTLINE: This is a multicenter study.
All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.
- Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.
- Group 2 (vulnerable): Patients receive specialized care and individualized treatment.
- Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed cancer
- •Undergoing out-patient care
- •Planning to undergo primary chemotherapeutic treatment or treatment with targeted agents for curative or palliative intent
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Able to understand the Flemish language, give informed consent, and be followed at the investigational site
- •Must be considered eligible for trial participation by the Investigator
- •No severe known dementia
- •No pre-existing major neurological or psychiatric problems
- •No refusal of the standard anticancer strategy as defined by the service instruction book
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)
Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC
次要结局
未报告次要终点