Clinical trial NCT02662179: Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
Official title: Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly Patients With a Solid Tumor
Keywords: Elderly patients
Onco-geriatrics
Fried criteria
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 62
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with solid tumors

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 ?

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

Primary outcomes:
measure: Functional decline - Katz (ADL)
timeFrame: 3 months after oncologic treatment
measure: Functional decline - Katz (ADL)
timeFrame: 6 months after oncologic treatment
measure: Functional decline - Lawton (IADL)
timeFrame: 3 months after oncologic treatment
measure: Functional decline - Lawton (IADL)
timeFrame: 6 months after oncologic treatment
measure: Physical decline - walking speed
timeFrame: 3 months after oncologic treatment
measure: Physical decline - walking speed
timeFrame: 6 months after oncologic treatment
measure: Physical decline - prehension force
timeFrame: 3 months after oncologic treatment
measure: Physical decline - prehension force
timeFrame: 6 months after oncologic treatment
measure: Cognitive decline - MMSE 30
timeFrame: 3 months after oncologic treatment
measure: Cognitive decline - MMSE 30
timeFrame: 6 months after oncologic treatment
measure: Quality of life - SF 36
timeFrame: 3 months after oncologic treatment
measure: Quality of life - SF36
timeFrame: 6 months after oncologic treatment
Secondary outcomes:
measure: Switch in oncologic treatment decision
timeFrame: Between diagnosis and oncologic treatment - maximum 8 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Florence Rousseau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Murielle Surquin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen X, Mao G, Leng SX. Frailty syndrome: an overview. Clin Interv Aging. 2014 Mar 19;9:433-41. doi: 10.2147/CIA.S45300. eCollection 2014.
citation: Extermann M, Aapro M, Bernabei R, Cohen HJ, Droz JP, Lichtman S, Mor V, Monfardini S, Repetto L, Sorbye L, Topinkova E; Task Force on CGA of the International Society of Geriatric Oncology. Use of comprehensive geriatric assessment in older cancer patients: recommendations from the task force on CGA of the International Society of Geriatric Oncology (SIOG). Crit Rev Oncol Hematol. 2005 Sep;55(3):241-52. doi: 10.1016/j.critrevonc.2005.06.003.
citation: Kristjansson SR, Nesbakken A, Jordhoy MS, Skovlund E, Audisio RA, Johannessen HO, Bakka A, Wyller TB. Comprehensive geriatric assessment can predict complications in elderly patients after elective surgery for colorectal cancer: a prospective observational cohort study. Crit Rev Oncol Hematol. 2010 Dec;76(3):208-17. doi: 10.1016/j.critrevonc.2009.11.002. Epub 2009 Dec 14.
citation: Ronning B, Wyller TB, Jordhoy MS, Nesbakken A, Bakka A, Seljeflot I, Kristjansson SR. Frailty indicators and functional status in older patients after colorectal cancer surgery. J Geriatr Oncol. 2014 Jan;5(1):26-32. doi: 10.1016/j.jgo.2013.08.001. Epub 2013 Aug 30.