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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Geriatric Assessment
• Intervention / Treatment: Other: CGA; Other: tailored care

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 Type: Observational
• Enrollment (Actual): 781

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Aarhus, Denmark, 8000 C
    • Geriatric Department Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

Referred for specialised palliative care

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Multi-level Health assessment
CGA with tailored care; CGA and a tailored follow-up and care for 90 days following the CGA	Other: CGA; Multi-level Health assessment; Other: tailored care; Tailored care based on problems identified by CGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short time mortality	dead within 90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year mortality	dead within 1 year	365 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Danish Cancer Society
• Investigators: Study Chair: Else M Damsgaard, DMsc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Comprehensive geriatric assessment; Short time mortality
• Other Study ID Numbers: 90-days mortality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No