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Clinical Trials/NCT02662179
NCT02662179
Completed
N/A

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

Brugmann University Hospital2 sites in 1 country62 target enrollmentNovember 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Elderly Patients With a Solid Tumor
Sponsor
Brugmann University Hospital
Enrollment
62
Locations
2
Primary Endpoint
Functional decline - Lawton (IADL)
Status
Completed
Last Updated
7 years ago

Overview

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 ?

Registry
clinicaltrials.gov
Start Date
November 1, 2015
End Date
April 2, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Murielle Surquin

Head of clinic

Brugmann University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional decline - Lawton (IADL)

Time Frame: 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

Time Frame: 6 months after oncologic treatment

Prehension force (Grip test) will be measured

Cognitive decline - MMSE 30

Time Frame: 6 months after oncologic treatment

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

Functional decline - Katz (ADL)

Time Frame: 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

Time Frame: 6 months after oncologic treatment

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

Quality of life - SF 36

Time Frame: 3 months after oncologic treatment

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

Quality of life - SF36

Time Frame: 6 months after oncologic treatment

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

Secondary Outcomes

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

Study Sites (2)

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