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CompletedNCT03814213Updated Apr 26, 2019

Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly Cancer Patients

An observational study in Geriatric Assessment and Cancer, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by University of Aarhus · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
781
Ages
70 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Geriatric Assessment
  • Cancer

Keywords

  • Comprehensive geriatric assessment
  • Cancer
  • Short time mortality
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

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

Exclusion criteria

-

Exclusion Criteria:

Referred for specialised palliative care

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
781 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: CGA

  • CGA with tailored care

    CGA and a tailored follow-up and care for 90 days following the CGA

    Other: CGA · Other: tailored care

Interventions

  • OtherCGA

    Multi-level Health assessment

  • Othertailored care

    Tailored care based on problems identified by CGA

06

What researchers measure

Primary outcomes

  1. short time mortality

    dead within 90 days

    Time frame: 90 days

Secondary outcomes

  1. 1 year mortality

    dead within 1 year

    Time frame: 365 days

07

Study locations

2 sites
  • Geriatric Department Aarhus University Hospital
    Aarhus, 8000 C, Denmark
  • Aarhus University Hospital
    Aarhus, 8000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03814213
Lead sponsor
University of Aarhus
Collaborators
Danish Cancer Society
Responsible party
Marianne Ørum (Principal Investigator, University of Aarhus) — Principal investigator
First posted
Jan 23, 2019
Start date
Jan 16, 2019
Primary completion
Apr 1, 2019
Completion
Apr 25, 2019
Last update
Apr 26, 2019

Study contacts

Else M Damsgaard, DMsc
study chair · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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