## Protocol Section
### Identification Module
**NCT ID:** NCT02662179

**Brief Title:** 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?

#### Organization Study ID Info
**ID:** CHUB-Fried
#### Organization
**Class:** OTHER
**Full Name:** Brugmann University Hospital
### Status Module
#### Completion Date
**Date:** 2019-04-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-04

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-04-02

**Type:** ACTUAL

#### Start Date
**Date:** 2015-11-01

**Type:** ACTUAL

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2016-01-25
**Type:** ESTIMATED
**Study First Submit Date:** 2015-11-27
**Study First Submit QC Date:** 2016-01-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brugmann University Hospital

#### Responsible Party

**Investigator Affiliation:** Brugmann University Hospital

**Investigator Full Name:** Murielle Surquin

**Investigator Title:** Head of clinic

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 ?

### Conditions Module

**Conditions:**

- Elderly Patients With a Solid Tumor

**Keywords:**

- Elderly patients

- Onco-geriatrics

- Fried criteria

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 62

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Other: Quality of life evaluation

- Other: Functional decline assessment

- Other: Physical decline assessment

- Other: Cognitive decline assessment

**Label:** Elderly patients with solid tumors

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Elderly patients with solid tumors

**Description:** 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.

**Name:** Quality of life evaluation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Elderly patients with solid tumors

**Description:** 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.

**Name:** Functional decline assessment

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Elderly patients with solid tumors

**Description:** 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.

**Name:** Physical decline assessment

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Elderly patients with solid tumors

**Description:** 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.

**Name:** Cognitive decline assessment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Functional decline - Katz (ADL)

**Time Frame:** 3 months after oncologic treatment

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

**Measure:** Functional decline - Katz (ADL)

**Time Frame:** 6 months after oncologic treatment

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

**Measure:** Functional decline - Lawton (IADL)

**Time Frame:** 3 months after oncologic treatment

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

**Measure:** Functional decline - Lawton (IADL)

**Time Frame:** 6 months after oncologic treatment

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

**Measure:** Physical decline - walking speed

**Time Frame:** 3 months after oncologic treatment

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

**Measure:** Physical decline - walking speed

**Time Frame:** 6 months after oncologic treatment

**Description:** Prehension force (Grip test) will be measured

**Measure:** Physical decline - prehension force

**Time Frame:** 3 months after oncologic treatment

**Description:** Prehension force (Grip test) will be measured

**Measure:** Physical decline - prehension force

**Time Frame:** 6 months after oncologic treatment

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

**Measure:** Cognitive decline - MMSE 30

**Time Frame:** 3 months after oncologic treatment

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

**Measure:** Cognitive decline - MMSE 30

**Time Frame:** 6 months after oncologic treatment

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

**Measure:** Quality of life - SF 36

**Time Frame:** 3 months after oncologic treatment

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

**Measure:** Quality of life - SF36

**Time Frame:** 6 months after oncologic treatment

#### Secondary Outcomes

**Description:** 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 ?

**Measure:** Switch in oncologic treatment decision

**Time Frame:** Between diagnosis and oncologic treatment - maximum 8 weeks

### Eligibility Module

**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

**Minimum Age:** 70 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** Elderly patients with solid tumors

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Brussels

**Country:** Belgium

**Facility:** Erasme Hospital

**Zip:** 1070

**Location 2:**

**City:** Brussels

**Country:** Belgium

**Facility:** CHU Brugmann

#### Overall Officials

**Official 1:**

**Affiliation:** CHU Brugmann

**Name:** Florence Rousseau, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** CHU Brugmann

**Name:** Murielle Surquin, MD,PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 24672230

**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.

**PMID:** 16084735

**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.

**PMID:** 20005123

**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.

**PMID:** 24484715

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
