Geriatric AssessmentNCT03814213
Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly Cancer Patients
An observational study of Geriatric Assessment and Cancer, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Older cancer patients referred to Oncology outpatient Clinic at Aarhus University Hospital have for a period been offered Comprehensive geriatric Assessment (CGA) as part of a routine practice. Oncology Department was responsible for planning the CGA. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Assessment, Cancer
- What is being tested?
- CGA and tailored care
- How many people
- 781 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Jan 2019to 25 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
- Healthy volunteers accepted
- Older adult
Study population: older cancer patients referred for oncology out patient Clinic for evaluaation regarding initialisation of treatment All stages of cancer is included, all kind of treatment is accepted including best supportive care.
Who may be able to join
- cancer of head and neck, lung, upper or lower gastro intestinal Canal Referred for evaluation in oncology department out patient Clinic Living in Aarhus, Odder, Favrskov or Skanderborg municipality
- -
Who cannot join
- Referred for specialised palliative care
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Geriatric Department Aarhus University Hospital
Aarhus, 8000 C
Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly
Older cancer patients referred to Oncology outpatient Clinic at Aarhus University Hospital have for a period been offered Comprehensive geriatric Assessment (CGA) as part of a routine practice. Oncology Department was responsible for planning the CGA. A number of patients did however not recieve this offer as planning failed. This Group of patients will be compared to patients recieving Geriatric assessment.
Patients recieving CGA is part of a Randomised controlled study (ID: NCT02837679) comparing CGA without 90 days follow-up to CGA with 90 days of Comprehensive geriatric care.
Patients are identified from electronic medical files. Data regarding death is obtained from Medical files.
Read the detailed description
Inclusion criteria:
- 70 years or more
- Cancer of the head and neck (HNC), lung (LC), upper gastro-intestinal- tract (UGI) or colo-rectal cancer (CRC)
- Referred to the Outpatient Clinic at department of oncology at Aarhus University Hospital for cancer treatment.
- Living in Aarhus, Favrskov, Odder or Skanderborg Municipalities
Exclusion:
- Referred for specialised palliative care
Patients with both newly diagnosed cancer disease and patients with a relapse of previously treated cancer disease are included. Patients qualify for participation regardless of the stage of the cancer disease and regardless if specific cancer treatment is initiated.
The oncology department is responsible for identifying patients and informing of the planned CGA.
All potential patients referred to the oncology outpatient clinic are identified by retrospective review of lists of planned consultations in the oncology department out patient clinic available in the electronic medical file approximately once a week. By this procedure patients who were not informed of the possibility of having a CGA are identified (Group1) Patients who are referred for geriatric evaluation have a complete CGA at baseline. The CGA comprises 7 instruments for assessing health: Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) for autonomy, Mini Nutritional Status (MNA) for nutritional state, Mini Mental State Examination (MMSE) for Cognitive state, Geriatric Depression Scale 15-item (GDS) for mood and Cumulative Illness Rating Scale - Geriatrics (CIRS-G) for comorbidity and number of daily medication for polypharmacy as previously published. According to CGA, patients were given a CGA-status of "fit", "vulnerable" or "frail". In order to be "fit" all of the following should be present: Independence in ADL and IADL, less than 5 daily medications, no severe comorbidity and no more than 2 well controlled comorbidities, normal cognitive ability and no indications of depression or malnutrition. Information on whether or not the multidisciplinary team initiated any individual action/advice based on the CGA in group 1 and group 2 was registered as well. Interventions initiated by the multidisciplinary team were recorded in four categories: medical changes, nutritional intervention, physical intervention or social intervention. These interventions were registered before randomization was performed Frail and vulnerable patients are offered participation in a controlled randomized study (Clinical trialsID: NCT02837679). Patients are randomly and 1:1 assigned to either: No tailored follow-up (Group 2) or 90 days tailored follow up (group 3). Randomization were performed by REDcap and allocated equally by CGA-status (frail/vulnerable), gender and index tumor site (CRC or no-CRC).
It is not possible to blind patients or the multidisciplinary team of the randomization.
Group 2 has no tailored follow up on the problems found during CGA. Group 3 has 90 days tailored follow-up on problems that were identified during CGA and problems that evolved during the follow-up period.
Tailored follow-up The tailored intervention consists of phone calls, home visits, or contact to community care-takers. A multidisciplinary team consisting of a trained geriatric nurse and a geriatrician specialist performs the follow up. The team can perform clinical investigation of patients, initiate changes in medication, or referral to further investigation. Furthermore transfusion of blood, fluids or i.v. antibiotics could be performed either at home or in the geriatric out patient clinic.
- Conditions
- Geriatric Assessment, Cancer
- Being tested
- CGA, tailored care
- Keywords
- Comprehensive geriatric assessment, Cancer, Short time mortality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGAOther
Multi-level Health assessment
tailored careOther
Tailored care based on problems identified by CGA
| Study group | Role | What they receive |
|---|---|---|
| No-CGA | Patients were not initially offered CGA due to no booking for CGA | |
| CGA alone | Patients had CGA, but no tailored follow-up upon identified problems Receives: Other: CGA | |
| CGA with tailored care | CGA and a tailored follow-up and care for 90 days following the CGA Receives: Other: CGA; Other: tailored care |
What is being measured
The primary outcome is the main question the study is designed to answer.
short time mortality
dead within 90 days
Measured: 90 days
Secondary outcomes (1)
1 year mortality
dead within 1 year
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start16 Jan 2019
- Primary completion1 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Marianne Ørum, University of Aarhus
- Investigators
- Else M Damsgaard, DMsc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814213
- Sponsor's protocol ID
- 90-days mortality
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly
- ClinicalTrials.gov ID
- NCT03814213
- Acronym / sponsor ID
- 90-days mortality
- Conditions
- Geriatric Assessment, Cancer
- Keywords
- Comprehensive geriatric assessment, Cancer, Short time mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- 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.
Older cancer patients referred to Oncology outpatient Clinic at Aarhus University Hospital have for a period been offered Comprehensive geriatric Assessment (CGA) as part of a routine practice. Oncology Department was responsible for planning the CGA. A number of patients did however not recieve this offer as planning failed. This Group of patients will be compared to patients recieving Geriatric assessment.
Patients recieving CGA is part of a Randomised controlled study (ID: NCT02837679) comparing CGA without 90 days follow-up to CGA with 90 days of Comprehensive geriatric care.
Patients are identified from electronic medical files. Data regarding death is obtained from Medical files.
Detailed description
Inclusion criteria:
- 70 years or more
- Cancer of the head and neck (HNC), lung (LC), upper gastro-intestinal- tract (UGI) or colo-rectal cancer (CRC)
- Referred to the Outpatient Clinic at department of oncology at Aarhus University Hospital for cancer treatment.
- Living in Aarhus, Favrskov, Odder or Skanderborg Municipalities
Exclusion:
- Referred for specialised palliative care
Patients with both newly diagnosed cancer disease and patients with a relapse of previously treated cancer disease are included. Patients qualify for participation regardless of the stage of the cancer disease and regardless if specific cancer treatment is initiated.
The oncology department is responsible for identifying patients and informing of the planned CGA.
All potential patients referred to the oncology outpatient clinic are identified by retrospective review of lists of planned consultations in the oncology department out patient clinic available in the electronic medical file approximately once a week. By this procedure patients who were not informed of the possibility of having a CGA are identified (Group1) Patients who are referred for geriatric evaluation have a complete CGA at baseline. The CGA comprises 7 instruments for assessing health: Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) for autonomy, Mini Nutritional Status (MNA) for nutritional state, Mini Mental State Examination (MMSE) for Cognitive state, Geriatric Depression Scale 15-item (GDS) for mood and Cumulative Illness Rating Scale - Geriatrics (CIRS-G) for comorbidity and number of daily medication for polypharmacy as previously published. According to CGA, patients were given a CGA-status of "fit", "vulnerable" or "frail". In order to be "fit" all of the following should be present: Independence in ADL and IADL, less than 5 daily medications, no severe comorbidity and no more than 2 well controlled comorbidities, normal cognitive ability and no indications of depression or malnutrition. Information on whether or not the multidisciplinary team initiated any individual action/advice based on the CGA in group 1 and group 2 was registered as well. Interventions initiated by the multidisciplinary team were recorded in four categories: medical changes, nutritional intervention, physical intervention or social intervention. These interventions were registered before randomization was performed Frail and vulnerable patients are offered participation in a controlled randomized study (Clinical trialsID: NCT02837679). Patients are randomly and 1:1 assigned to either: No tailored follow-up (Group 2) or 90 days tailored follow up (group 3). Randomization were performed by REDcap and allocated equally by CGA-status (frail/vulnerable), gender and index tumor site (CRC or no-CRC).
It is not possible to blind patients or the multidisciplinary team of the randomization.
Group 2 has no tailored follow up on the problems found during CGA. Group 3 has 90 days tailored follow-up on problems that were identified during CGA and problems that evolved during the follow-up period.
Tailored follow-up The tailored intervention consists of phone calls, home visits, or contact to community care-takers. A multidisciplinary team consisting of a trained geriatric nurse and a geriatrician specialist performs the follow up. The team can perform clinical investigation of patients, initiate changes in medication, or referral to further investigation. Furthermore transfusion of blood, fluids or i.v. antibiotics could be performed either at home or in the geriatric out patient clinic.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No-CGA | – | –Patients were not initially offered CGA due to no booking for CGA |
| CGA alone | – | Other: CGAPatients had CGA, but no tailored follow-up upon identified problems |
| CGA with tailored care | – | Other: CGA, Other: tailored careCGA and a tailored follow-up and care for 90 days following the CGA |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- older cancer patients referred for oncology out patient Clinic for evaluaation regarding initialisation of treatment All stages of cancer is included, all kind of treatment is accepted including best supportive care.
Key inclusion criteria (2 listed)
- cancer of head and neck, lung, upper or lower gastro intestinal Canal Referred for evaluation in oncology department out patient Clinic Living in Aarhus, Odder, Favrskov or Skanderborg municipality
- -
Key exclusion criteria (1 listed)
- Referred for specialised palliative care
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 |
|---|---|---|
| CGAMulti-level Health assessment | Other | CGA alone, CGA with tailored care |
| tailored careTailored care based on problems identified by CGA | Other | CGA with tailored care |
Primary outcome
short time mortality
Time frame: 90 days
dead within 90 days
1 secondary outcome
1 year mortality
Time frame: 365 days
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 26 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Else M Damsgaard, DMsc study chair
Aarhus University Hospital
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 Geriatric Assessment and Cancer, run by University of Aarhus at 2 sites in Denmark.
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 2 inclusion and 1 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 26 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 Denmark. 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?
short time mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2019.