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

Primary Purpose

Colon Cancer, Colon Neoplasm, Frail Elderly Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Geriatric intervention
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev and Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Geriatric intervention

control.

Arm Description

A comprehensive geriatric assessment and intervention, including exercise program.

Usual treatment and care.

Outcomes

Primary Outcome Measures

30-second chair stand test (30s-CST)
functional test measuring lower body strength

Secondary Outcome Measures

physical function and capacity - 6-minute-walk-test
6-minute-walk-test
physical function and capacity - hand grip strength
hand grip strength
physical function and capacity - 6-meter gait speed
6-meter gait speed
Patient reported Quality of Life: EORTC
EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)
Patient reported Quality of Life: EORTC ELD14
EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)
Quality of recovery after surgery: questionnaire
Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)
body composition
measured by Bioimpedance assessment
body composition
measured by dual-energy x-ray absorptiometry
inflammatory biomarker - CRP
the concentration of CRP (CRP C-reactive Protein)
inflammatory biomarker - Interleukin 6
the concentration of interleukin 6
inflammatory biomarker YKL-40
the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)
inflammatory biomarkers immuno-oncology
the concentration of 92 proteins associated with immuno-oncology (OLink)
sarcopenia biomarker GDF-11
the concentration of GDF-11 (GDF Growth Differentiation Factor)
sarcopenia biomarker GDF
the concentration of GDF-15 (GDF Growth Differentiation Factor)
Postoperative complications
Measured with Clavien Dindo classification (grade I-V where grade V is death)
readmission
Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.
survival
number of survivors after surgery
mortality
number of patients death
number of patients to start up of adjuvant chemotherapy after surgery.
according to guidelines, if physical condition allows it (and patient accepts it).
start up time of adjuvant chemotherapy after surgery
measured in days (if relevant)
number of series of adjuvant chemotherapy
doses of adjuvant chemotherapy

Full Information

First Posted
October 19, 2018
Last Updated
August 1, 2022
Sponsor
Herlev and Gentofte Hospital
Collaborators
Velux Fonden, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03719573
Brief Title
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
Acronym
GEPOC
Official Title
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
Velux Fonden, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colon Neoplasm, Frail Elderly Syndrome, Colorectal Cancer
Keywords
Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Physiotherapist assessing function status.
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Geriatric intervention
Arm Type
Experimental
Arm Description
A comprehensive geriatric assessment and intervention, including exercise program.
Arm Title
control.
Arm Type
No Intervention
Arm Description
Usual treatment and care.
Intervention Type
Other
Intervention Name(s)
Geriatric intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-second chair stand test (30s-CST)
Description
functional test measuring lower body strength
Time Frame
baseline to 14 weeks after surgery
Secondary Outcome Measure Information:
Title
physical function and capacity - 6-minute-walk-test
Description
6-minute-walk-test
Time Frame
baseline to 14 weeks after surgery
Title
physical function and capacity - hand grip strength
Description
hand grip strength
Time Frame
baseline to 14 weeks after surgery
Title
physical function and capacity - 6-meter gait speed
Description
6-meter gait speed
Time Frame
baseline to 14 weeks after surgery
Title
Patient reported Quality of Life: EORTC
Description
EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)
Time Frame
baseline to 14 weeks after surgery
Title
Patient reported Quality of Life: EORTC ELD14
Description
EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)
Time Frame
baseline to 14 weeks after surgery
Title
Quality of recovery after surgery: questionnaire
Description
Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)
Time Frame
1 day before surgery (baseline) to 3 days after surgery
Title
body composition
Description
measured by Bioimpedance assessment
Time Frame
baseline to 14 weeks after surgery.
Title
body composition
Description
measured by dual-energy x-ray absorptiometry
Time Frame
baseline to 14 weeks after surgery.
Title
inflammatory biomarker - CRP
Description
the concentration of CRP (CRP C-reactive Protein)
Time Frame
baseline to 14 weeks after surgery
Title
inflammatory biomarker - Interleukin 6
Description
the concentration of interleukin 6
Time Frame
baseline to 14 weeks after surgery
Title
inflammatory biomarker YKL-40
Description
the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)
Time Frame
baseline to 14 weeks after surgery
Title
inflammatory biomarkers immuno-oncology
Description
the concentration of 92 proteins associated with immuno-oncology (OLink)
Time Frame
baseline to 14 weeks after surgery
Title
sarcopenia biomarker GDF-11
Description
the concentration of GDF-11 (GDF Growth Differentiation Factor)
Time Frame
baseline to 14 weeks after surgery
Title
sarcopenia biomarker GDF
Description
the concentration of GDF-15 (GDF Growth Differentiation Factor)
Time Frame
baseline to 14 weeks after surgery
Title
Postoperative complications
Description
Measured with Clavien Dindo classification (grade I-V where grade V is death)
Time Frame
30 days + 90 days
Title
readmission
Description
Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.
Time Frame
30 days after surgery and 90 days after surgery
Title
survival
Description
number of survivors after surgery
Time Frame
10 years
Title
mortality
Description
number of patients death
Time Frame
baseline to 3 months
Title
number of patients to start up of adjuvant chemotherapy after surgery.
Description
according to guidelines, if physical condition allows it (and patient accepts it).
Time Frame
14 weeks
Title
start up time of adjuvant chemotherapy after surgery
Description
measured in days (if relevant)
Time Frame
14 weeks
Title
number of series of adjuvant chemotherapy
Time Frame
14 weeks
Title
doses of adjuvant chemotherapy
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia S Johansen, MD, PhD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Herlev
State/Province
Region H
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
TBA
Citations:
PubMed Identifier
33516195
Citation
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.
Results Reference
derived

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

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