NCT02662179

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 ?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3.4 years

First QC Date

November 27, 2015

Last Update Submit

April 2, 2019

Conditions

Elderly Patients With a Solid Tumor

Keywords

Elderly patientsOnco-geriatricsFried criteria

Outcome Measures

Primary Outcomes (12)

  • Functional decline - Katz (ADL)

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

    3 months after oncologic treatment

  • Functional decline - Katz (ADL)

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

    6 months after oncologic treatment

  • Functional decline - Lawton (IADL)

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

    3 months after oncologic treatment

  • Functional decline - Lawton (IADL)

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

    6 months after oncologic treatment

  • Physical decline - walking speed

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

    3 months after oncologic treatment

  • Physical decline - walking speed

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

    6 months after oncologic treatment

  • Physical decline - prehension force

    Prehension force (Grip test) will be measured

    3 months after oncologic treatment

  • Physical decline - prehension force

    Prehension force (Grip test) will be measured

    6 months after oncologic treatment

  • Cognitive decline - MMSE 30

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

    3 months after oncologic treatment

  • Cognitive decline - MMSE 30

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

    6 months after oncologic treatment

  • Quality of life - SF 36

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

    3 months after oncologic treatment

  • Quality of life - SF36

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

    6 months after oncologic treatment

Secondary Outcomes (1)

  • Switch in oncologic treatment decision

    Between diagnosis and oncologic treatment - maximum 8 weeks

Study Arms (1)

Elderly patients with solid tumors

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).

Other: Quality of life evaluationOther: Functional decline assessmentOther: Physical decline assessmentOther: Cognitive decline assessment

Interventions

Quality of life evaluationOTHER

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.

Elderly patients with solid tumors
Functional decline assessmentOTHER

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.

Elderly patients with solid tumors
Physical decline assessmentOTHER

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.

Elderly patients with solid tumors
Cognitive decline assessmentOTHER

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.

Elderly patients with solid tumors

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with solid tumors

You may qualify if:

  • 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

You may not qualify if:

  • Patients unable to participate in the global geriatric evaluation (auditive or visual problems)
  • Language barrier
  • Clear therapeutic abstention
  • Bedridden patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasme Hospital

Brussels, 1070, Belgium

Location

CHU Brugmann

Brussels, Belgium

Location

Related Publications (4)

  • 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: 24672230BACKGROUND

  • 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: 16084735BACKGROUND

  • 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: 20005123BACKGROUND

  • 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: 24484715BACKGROUND

Study Officials

  • Florence Rousseau, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

  • Murielle Surquin, MD,PhD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

November 27, 2015

First Posted

January 25, 2016

Study Start

November 1, 2015

Primary Completion

April 2, 2019

Study Completion

April 2, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

BE(2)