Elderly Patients With a Solid TumorNCT02662179
Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
An observational study of Elderly Patients With a Solid Tumor, run by Brugmann University Hospital at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly Patients With a Solid Tumor
- What is being tested?
- Quality of life evaluation, Functional decline assessment and Physical decline assessment
- How many people
- 62 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2015to 2 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with solid tumors
Who may be able to join
- 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
Who cannot join
- Patients unable to participate in the global geriatric evaluation (auditive or visual problems)
- Language barrier
- Clear therapeutic abstention
- Bedridden patients
Trial locations and contacts
2 sites in 1 country.
About this study
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).
Read more
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 ?
Read the 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
- Elderly Patients With a Solid Tumor
- Being tested
- Quality of life evaluation, Functional decline assessment, Physical decline assessment, Cognitive decline assessment
- Keywords
- Elderly patients, Onco-geriatrics, Fried criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Quality of life evaluation; Other: Functional decline assessment; Other: Physical decline assessment; Other: Cognitive decline assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional decline - Katz (ADL)
The functional decline will be assessed by using the Katz Basic Activities of Daily Living (ADL) score
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after oncologic treatment
Physical decline - walking speed
Will be assessed by the 'Timed Up and Go' test (TUG)
Measured: 3 months after oncologic treatment
Physical decline - walking speed
Will be assessed by the 'Timed Up and Go' test (TUG)
Measured: 6 months after oncologic treatment
Physical decline - prehension force
Prehension force (Grip test) will be measured
Measured: 3 months after oncologic treatment
Physical decline - prehension force
Prehension force (Grip test) will be measured
Measured: 6 months after oncologic treatment
Cognitive decline - MMSE 30
Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
Measured: 3 months after oncologic treatment
Cognitive decline - MMSE 30
Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
Measured: 6 months after oncologic treatment
Quality of life - SF 36
Will be assessed by the Short Form-36 (SF-36) questionnaire
Measured: 3 months after oncologic treatment
Quality of life - SF36
Will be assessed by the Short Form-36 (SF-36) questionnaire
Measured: 6 months after oncologic treatment
Secondary outcomes (1)
Switch in oncologic treatment decision
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 ?
Measured: Between diagnosis and oncologic treatment - maximum 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start1 Nov 2015
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Elderly Patients With a Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Florence Rousseau, MD, Principal investigator, CHU BrugmannMurielle Surquin, MD,PhD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662179
- Sponsor's protocol ID
- CHUB-Fried
- Status last verified
- Apr 2019
- First submitted
- 27 Nov 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24672230Extermann 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.
PubMed 16084735Kristjansson 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.
PubMed 20005123Ronning 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.
PubMed 24484715
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
- ClinicalTrials.gov ID
- NCT02662179
- Acronym / sponsor ID
- CHUB-Fried
- Conditions
- Elderly Patients With a Solid Tumor
- Keywords
- Elderly patients, Onco-geriatrics, Fried criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with solid tumors | – | Other: Quality of life evaluation, Other: Functional decline assessment, Other: Physical decline assessment, Other: Cognitive decline assessmentThe 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with solid tumors
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients unable to participate in the global geriatric evaluation (auditive or visual problems)
- Language barrier
- Clear therapeutic abstention
- Bedridden patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life evaluationAssess 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. | Other | Elderly patients with solid tumors |
| Functional decline assessmentAssess 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. | Other | Elderly patients with solid tumors |
| Physical decline assessmentAssess 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. | Other | Elderly patients with solid tumors |
| Cognitive decline assessmentAssess 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. | Other | Elderly patients with solid tumors |
Primary outcome
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
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
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
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 - walking speed
Time frame: 3 months after oncologic treatment
Will be assessed by the 'Timed Up and Go' test (TUG)
Physical decline - walking speed
Time frame: 6 months after oncologic treatment
Will be assessed by the 'Timed Up and Go' test (TUG)
Physical decline - prehension force
Time frame: 3 months after oncologic treatment
Prehension force (Grip test) will be measured
Physical decline - prehension force
Time frame: 6 months after oncologic treatment
Prehension force (Grip test) will be measured
Cognitive decline - MMSE 30
Time frame: 3 months after oncologic treatment
Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
Cognitive decline - MMSE 30
Time frame: 6 months after oncologic treatment
Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
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
1 secondary outcome
Switch in oncologic treatment decision
Time frame: Between diagnosis and oncologic treatment - maximum 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 24672230Chen 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.
- Background: PubMed 16084735Extermann 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.
- Background: PubMed 20005123Kristjansson 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.
- Background: PubMed 24484715Ronning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Rousseau, MD principal investigator
CHU Brugmann
Murielle Surquin, MD,PhD principal investigator
CHU Brugmann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Patients With a Solid Tumor, run by Brugmann University Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional decline - Katz (ADL) (time frame: 3 months after oncologic treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662179, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.