Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

NCT ID: NCT03719573

Last Updated: 2022-08-03

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2022-05-10

Brief Summary

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The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.

The main aim of the study us to see if the functional decline in this group can be reduced.

Detailed Description

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This is a randomized, controlled trial on frail older patients (aged 65 years or older) 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 intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.

Conditions

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Colon Cancer Colon Neoplasm Frail Elderly Syndrome Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Physiotherapist assessing function status.

Study Groups

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Geriatric intervention

A comprehensive geriatric assessment and intervention, including exercise program.

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.

Usual treatment and care.

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

* elective surgery for colorectal cancer
* frail
* ability to read and speak danish (informed concent)

Exclusion Criteria

* any physical condition that hinder physical exercise (eg. no legs)
* not able to concent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Velux Fonden

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Troels Gammeltoft Dolin

MD, Principal Investigator, Department of internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia S Johansen, MD, PhD

Role: STUDY_CHAIR

Professor

Locations

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Herlev and Gentofte Hospital

Herlev, Region H, Denmark

Site Status

Countries

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Denmark

References

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Dolin TG, Mikkelsen MK, Jakobsen HL, Vinther A, Zerahn B, Nielsen DL, Johansen JS, Lund CM, Suetta C. The prevalence of sarcopenia and cachexia in older patients with localized colorectal cancer. J Geriatr Oncol. 2023 Jan;14(1):101402. doi: 10.1016/j.jgo.2022.11.001. Epub 2022 Nov 21.

Reference Type DERIVED
PMID: 36424269 (View on PubMed)

Dolin TG, Mikkelsen M, Jakobsen HL, Nordentoft T, Pedersen TS, Vinther A, Zerahn B, Vistisen KK, Suetta C, Nielsen D, Johansen JS, Lund CM. Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial). BMC Geriatr. 2021 Jan 30;21(1):88. doi: 10.1186/s12877-021-02045-9.

Reference Type DERIVED
PMID: 33516195 (View on PubMed)

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id

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