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临床试验/NCT02662179
NCT02662179已完成不适用

Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?

Brugmann University Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Functional decline - Lawton (IADL)

研究概览

简要总结

Identifying the frail elderly patients or those at risk of becoming frail has become a cornerstone of modern geriatric medicine. Many instruments have been developed to identify fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5 criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight loss. The patient is fragile if it meets at least three out of five criteria. It is 'pre-fragile' if it meets one or two criteria.

In onco-geriatrics, the International onco-geriatrics society recommends the implementation of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8 are then referred to the geriatric team to benefit from a comprehensive geriatric assessment. This evaluation is interpreted by the geriatrician, who proposes an action plan to overcome the various problems of the elderly patient. The evaluation can also help the oncologist in the choice of treatment for the patient: palliative care, standard treatment or adapted treatment (No-go, Go-go or slow-go).

The investigators would like to assess if fragility as defined by the Fried criteria is predictive of a functional, physical or cognitive decline, or a loss of quality of life in patients treated for a solid malignant tumor.

Furthermore, they will assess if the frailness categorization has an impact on the oncologic treatment decision. Does the oncologist switches the patient's oncologic treatment after being informed of the frailness status ?

详细描述

Identifying the frail elderly patients or those at risk of becoming frail has become a cornerstone of modern geriatric medicine. The term 'frail' has been elusive during quite a long time. Several studies have been conducted over the last 15 years to clarify this concept: fragility is a clinical syndrome defined by an increase of vulnerability following a decline in physiological reserves and organic functions, that compromises the ability to cope with daily life or acute stress.

Many instruments have been developed to identify fragility at the individual level. The 'Fragile' phenotype defined by Fried (Cardiovascular Health Study) is based on 5 criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight loss. The patient is fragile if it meets at least three out of five criteria. It is 'pre-fragile' if it meets one or two criteria.

In onco-geriatrics, the International onco-geriatrics society recommends the implementation of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8 are then referred to the geriatric team to benefit from a comprehensive geriatric assessment. This evaluation is interpreted by the geriatrician, who draws an action plan to overcome the various problems of the elderly patient. The evaluation also helps the oncologist in the choice of treatment for the patient: palliative care, standard treatment or adapted treatment (No-go, Go-go or slow-go).

However, many studies have shown that fragile patients had a greater morbidity and mortality than non-fragile patients. The rate of postoperative complications and the length of stay are significantly higher in fragile patients suffering from a colorectal cancer treated by elective surgery.

On the other hand and quite surprisingly, another study showed that none of the comprehensive geriatric assessment based fragility indicators was able to predict a post-surgery functional decline in patients having undergone surgery for colorectal cancer.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Patients with a solid malign tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer, urinary tract cancer (including bladder cancer).
  • Patients having not undergone treatment yet (be it surgery, chemotherapy or radiotherapy)
  • Ambulatory or hospitalized patients

排除标准

  • Patients unable to participate in the global geriatric evaluation (auditive or visual problems)
  • Language barrier
  • Clear therapeutic abstention
  • Bedridden patients

结局指标

主要结局

Functional decline - Lawton (IADL)

时间窗: 6 months after oncologic treatment

The functional decline will be assessed by using the Lawton Instrumental Activities of Daily Living (IADL) score

Physical decline - prehension force

时间窗: 6 months after oncologic treatment

Prehension force (Grip test) will be measured

Cognitive decline - MMSE 30

时间窗: 6 months after oncologic treatment

Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire

Functional decline - Katz (ADL)

时间窗: 6 months after oncologic treatment

The functional decline will be assessed by using the Katz Basic Activities of Daily Living (ADL) score

Physical decline - walking speed

时间窗: 6 months after oncologic treatment

Will be assessed by the 'Timed Up and Go' test (TUG)

Quality of life - SF 36

时间窗: 3 months after oncologic treatment

Will be assessed by the Short Form-36 (SF-36) questionnaire

Quality of life - SF36

时间窗: 6 months after oncologic treatment

Will be assessed by the Short Form-36 (SF-36) questionnaire

次要结局

  • Switch in oncologic treatment decision(Between diagnosis and oncologic treatment - maximum 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murielle Surquin

Head of clinic

Brugmann University Hospital

研究点 (2)

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