AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Denmark

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.

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 groups in NCT03814213
Study groupRoleWhat they receive
No-CGAPatients were not initially offered CGA due to no booking for CGA
CGA alonePatients had CGA, but no tailored follow-up upon identified problems
Receives: Other: CGA
CGA with tailored careCGA 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.

  1. short time mortality

    dead within 90 days

    Measured: 90 days

Secondary outcomes (1)
  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.

  1. First posted23 Jan 2019
  2. Study start16 Jan 2019
  3. Primary completion1 Apr 2019
  4. Study completion25 Apr 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in