NCT02072733

Brief Summary

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 11, 2017

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

February 19, 2014

Last Update Submit

April 7, 2017

Conditions

ElderlyCancer

Keywords

frailtyoncogeriatricsMultidisciplinary interventionmultimorbidityComprehensive geriatric assessmentpatients

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.

    3 months

Secondary Outcomes (1)

  • frailty status

    3 months

Other Outcomes (2)

  • Impact of CGA on the oncologist´s treatment plan

    3 months

  • Complications

    3 months

Study Arms (1)

geriatric assessment

OTHER

The intervention is individual and based on the Comprehensive Geriatric assessment (CGA) : collection of information on comorbidity, polypharmacy, physical, psychological and cognitive functions, nutrition as well as social status and support. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment

Other: Comprehensive geriatric assessment

Interventions

Comprehensive geriatric assessmentOTHER

Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.

geriatric assessment

Eligibility Criteria

Age70 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • Patients from Central Denmark Region (Region Midtjylland)
  • Lung cancer, Upper Gastrointestinal Cancer, cancer of head and neck and Colo-Rectal Cancer
  • referred for assessment of treatment to the oncological department at Aarhus University Hospital.

You may not qualify if:

  • Patients referred to specialized palliative care at the first visit to the oncological outpatient clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department Aarhus University Hospital

Aarhus, 8000 C, Denmark

Location

MeSH Terms

Conditions

NeoplasmsFrailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Else Marie Damsgaard, Professor

    Geriatric Department Aarhus University Hospital Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 27, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 11, 2017

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)