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

Completed

• Conditions: Elderly Patients With a Solid Tumor
• Interventions: Other: Quality of life evaluation; Other: Functional decline assessment; Other: Physical decline assessment; Other: Cognitive decline assessment

• Registration Number: NCT02662179
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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 ?

Detailed Description

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.

One of the primary goals of geriatry being to maintain the autonomy and independence of patients.

The investigators would thus 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 ?

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Status Verified: 2019-04
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly patients with solid tumors	Functional decline assessment	The group will include elderly patients with a malignant solid tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer or urinary tract cancer (including bladder cancer).
Elderly patients with solid tumors	Quality of life evaluation	The group will include elderly patients with a malignant solid tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer or urinary tract cancer (including bladder cancer).
Elderly patients with solid tumors	Cognitive decline assessment	The group will include elderly patients with a malignant solid tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer or urinary tract cancer (including bladder cancer).
Elderly patients with solid tumors	Physical decline assessment	The group will include elderly patients with a malignant solid tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer or urinary tract cancer (including bladder cancer).

Primary Outcome Measures

Name	Time	Method
Functional decline - Lawton (IADL)	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	6 months after oncologic treatment	Prehension force (Grip test) will be measured
Cognitive decline - MMSE 30	6 months after oncologic treatment	Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
Functional decline - Katz (ADL)	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	6 months after oncologic treatment	Will be assessed by the 'Timed Up and Go' test (TUG)
Quality of life - SF 36	3 months after oncologic treatment	Will be assessed by the Short Form-36 (SF-36) questionnaire
Quality of life - SF36	6 months after oncologic treatment	Will be assessed by the Short Form-36 (SF-36) questionnaire

Secondary Outcome Measures

Name	Time	Method
Switch in oncologic treatment decision	Between diagnosis and oncologic treatment - maximum 8 weeks	Patients will be classified as frail, vulnerable or robust according to the Fried criteria. Does the oncologist changes his/her therapeutic treatment decision after being aware of the frailness categorization ?

Trial Locations

Locations (2)

Erasme Hospital; 🇧🇪 Brussels, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium