Cancer Clinical Trial
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.
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.
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