NCT03719573

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

October 19, 2018

Last Update Submit

August 1, 2022

Conditions

Colon CancerColon NeoplasmFrail Elderly SyndromeColorectal Cancer

Keywords

Colon CancerFrailtyGeriatric assessmentperioperative careexercisequality of recoverycolorectal

Outcome Measures

Primary Outcomes (1)

  • 30-second chair stand test (30s-CST)

    functional test measuring lower body strength

    baseline to 14 weeks after surgery

Secondary Outcomes (22)

  • physical function and capacity - 6-minute-walk-test

    baseline to 14 weeks after surgery

  • physical function and capacity - hand grip strength

    baseline to 14 weeks after surgery

  • physical function and capacity - 6-meter gait speed

    baseline to 14 weeks after surgery

  • Patient reported Quality of Life: EORTC

    baseline to 14 weeks after surgery

  • Patient reported Quality of Life: EORTC ELD14

    baseline to 14 weeks after surgery

  • +17 more secondary outcomes

Study Arms (2)

Geriatric intervention

EXPERIMENTAL

A comprehensive geriatric assessment and intervention, including exercise program.

Other: Geriatric intervention

control.

NO INTERVENTION

Usual treatment and care.

Interventions

Geriatric interventionOTHER

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.

Geriatric intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • any physical condition that hinder physical exercise (eg. no legs)
  • not able to concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Region H, 2730, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 36424269DERIVED

  • 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.

    PMID: 33516195DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsFrailtyMotor Activity

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Julia S Johansen, MD, PhD

    Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Physiotherapist assessing function status.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator, Department of internal Medicine

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 25, 2018

Study Start

February 21, 2019

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

DK(1)