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NCT Number: NCT02662179

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

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 ?

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

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About this study

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 ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life evaluation

Other

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.

Functional decline assessment

Other

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.

Physical decline assessment

Other

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.

Cognitive decline assessment

Other

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.

Primary outcomes

  1. Functional decline - Katz (ADL)

    Time frame: 3 months after oncologic treatment

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

  2. 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

  3. Functional decline - Lawton (IADL)

    Time frame: 3 months after oncologic treatment

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

  4. 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

  5. Physical decline - walking speed

    Time frame: 3 months after oncologic treatment

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

  6. Physical decline - walking speed

    Time frame: 6 months after oncologic treatment

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

  7. Physical decline - prehension force

    Time frame: 3 months after oncologic treatment

    Prehension force (Grip test) will be measured

  8. Physical decline - prehension force

    Time frame: 6 months after oncologic treatment

    Prehension force (Grip test) will be measured

  9. Cognitive decline - MMSE 30

    Time frame: 3 months after oncologic treatment

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

  10. Cognitive decline - MMSE 30

    Time frame: 6 months after oncologic treatment

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

  11. Quality of life - SF 36

    Time frame: 3 months after oncologic treatment

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

  12. Quality of life - SF36

    Time frame: 6 months after oncologic treatment

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

Secondary outcomes

  1. Switch in oncologic treatment decision

    Time frame: 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 ?

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2016
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.