Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02662179
Enrollment
62
Registered
2016-01-25
Start date
2015-11-01
Completion date
2019-04-02
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Patients With a Solid Tumor

Keywords

Elderly patients, Onco-geriatrics, Fried criteria

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 ?

Interventions

Assess the quality of life ('SF-36' questionnaire) of patients 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.

OTHERFunctional decline assessment

Assess functional decline ('Katz ADL' Score and 'Lawton IADL' Score) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.

OTHERPhysical decline assessment

Assess physical decline (walking speed and prehension force) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.

OTHERCognitive decline assessment

Assess cognitive decline 3 and 6 months ('MMSE 30' questionnaire) after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life - SF366 months after oncologic treatmentWill be assessed by the Short Form-36 (SF-36) questionnaire
Functional decline - Katz (ADL)3 months after oncologic treatmentThe functional decline will be assessed by using the Katz Basic Activities of Daily Living (ADL) score
Functional decline - Lawton (IADL)3 months after oncologic treatmentThe functional decline will be assessed by using the Lawton Instrumental Activities of Daily Living (IADL) score
Physical decline - walking speed3 months after oncologic treatmentWill be assessed by the 'Timed Up and Go' test (TUG)
Physical decline - prehension force3 months after oncologic treatmentPrehension force (Grip test) will be measured
Cognitive decline - MMSE 303 months after oncologic treatmentWill be assessed by the mini mental state evaluation (MMSE 30) questionnaire
Quality of life - SF 363 months after oncologic treatmentWill be assessed by the Short Form-36 (SF-36) questionnaire

Secondary

MeasureTime frameDescription
Switch in oncologic treatment decisionBetween diagnosis and oncologic treatment - maximum 8 weeksPatients 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 ?

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026