Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

NCT ID: NCT01321658

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-10-31

Brief Summary

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This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Geriatric intervention

Group Type EXPERIMENTAL

Geriatric intervention

Intervention Type OTHER

A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Geriatric intervention

A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 65+
* Elective surgery for colorectal cancer
* Frail

Exclusion Criteria

* Acute surgery
* Not able to consent
* Does not consent with registration
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Cancer Society

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Torgeir Bruun Wyller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Torgeir B Wyller, Dr.med

Role: STUDY_CHAIR

Geriatric dept., Oslo University hospital

Locations

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Dept of gastrointestinal surgery, Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2010/1634

Identifier Type: -

Identifier Source: org_study_id

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