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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Frail Elderly Syndrome; Colon Cancer; Colon Neoplasm
• Intervention / Treatment: Other: Geriatric intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Herlev, Region H, Denmark, 2730
      • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Geriatric intervention; A comprehensive geriatric assessment and intervention, including exercise program.	Other: 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.
No Intervention: control.; Usual treatment and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-second chair stand test (30s-CST)	functional test measuring lower body strength	baseline to 14 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical function and capacity - 6-minute-walk-test	6-minute-walk-test	baseline to 14 weeks after surgery
physical function and capacity - hand grip strength	hand grip strength	baseline to 14 weeks after surgery
physical function and capacity - 6-meter gait speed	6-meter gait speed	baseline to 14 weeks after surgery
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)	baseline to 14 weeks after surgery
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)	baseline to 14 weeks after surgery
Quality of recovery after surgery: questionnaire	Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)	1 day before surgery (baseline) to 3 days after surgery
body composition	measured by Bioimpedance assessment	baseline to 14 weeks after surgery.
body composition	measured by dual-energy x-ray absorptiometry	baseline to 14 weeks after surgery.
inflammatory biomarker - CRP	the concentration of CRP (CRP C-reactive Protein)	baseline to 14 weeks after surgery
inflammatory biomarker - Interleukin 6	the concentration of interleukin 6	baseline to 14 weeks after surgery
inflammatory biomarker YKL-40	the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)	baseline to 14 weeks after surgery
inflammatory biomarkers immuno-oncology	the concentration of 92 proteins associated with immuno-oncology (OLink)	baseline to 14 weeks after surgery
sarcopenia biomarker GDF-11	the concentration of GDF-11 (GDF Growth Differentiation Factor)	baseline to 14 weeks after surgery
sarcopenia biomarker GDF	the concentration of GDF-15 (GDF Growth Differentiation Factor)	baseline to 14 weeks after surgery
Postoperative complications	Measured with Clavien Dindo classification (grade I-V where grade V is death)	30 days + 90 days
readmission	Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.	30 days after surgery and 90 days after surgery
survival	number of survivors after surgery	10 years
mortality	number of patients death	baseline to 3 months
number of patients to start up of adjuvant chemotherapy after surgery.	according to guidelines, if physical condition allows it (and patient accepts it).	14 weeks
start up time of adjuvant chemotherapy after surgery	measured in days (if relevant)	14 weeks
number of series of adjuvant chemotherapy		14 weeks
doses of adjuvant chemotherapy		14 weeks

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: University of Copenhagen; Velux Fonden
• Investigators: Study Chair: Julia S Johansen, MD, PhD, PROFESSOR

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: exercise; quality of recovery; colorectal; Colon Cancer; Frailty; perioperative care; Geriatric assessment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: TBA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No