Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
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
- 否
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
Murielle Surquin
Head of clinic
Brugmann University Hospital
