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

Overview

The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (70 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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2021

Detailed Description

This is a randomized, controlled trial on frail older patients (aged 70 years or older) with colon 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Geriatric intervention
    • A comprehensive geriatric assessment and intervention, including exercise program.
  • No Intervention: control.
    • Usual treatment and care.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • physical function and capacity – 6-minute-walk-test
    • Time Frame: baseline to 14 weeks after surgery
    • 6-minute-walk-test
  • physical function and capacity – hand grip strength
    • Time Frame: baseline to 14 weeks after surgery
    • hand grip strength
  • physical function and capacity – 6-meter gait speed
    • Time Frame: baseline to 14 weeks after surgery
    • 6-meter gait speed
  • Patient reported Quality of Life: EORTC
    • Time Frame: baseline to 14 weeks after surgery
    • 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
    • Time Frame: baseline to 14 weeks after surgery
    • EORTC European Organisation for Research and Treatment of Cancer questionnaire ELD14 (14-54 points where 54 is the worst)
  • Quality of recovery after surgery: questionnaire
    • Time Frame: 1 day before surgery (baseline) to 3 days after surgery
    • Measured with the questionnaire: Quality of Recovery – 15 questionnaire (0-150 points where 0 points is the worst)
  • bodycomposition
    • Time Frame: baseline to 14 weeks after surgery.
    • measured by Bioimpedance assessment
  • bodycomposition
    • Time Frame: baseline to 14 weeks after surgery.
    • measured by dual-energy x-ray absorptiometry
  • inflammatory biomarker – CRP
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of CRP
  • inflammatory biomarker – Interleukin 6
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of interleukin 6
  • inflammatory biomarker YKL-40
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of YKL-40
  • inflammatory biomarkers immuno-oncology
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of 92 proteins associated with immuno-oncology (OLink)
  • sarcopenia biomarker GDF-11
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of GDF-11
  • sarcopenia biomarker GDF
    • Time Frame: baseline to 14 weeks after surgery
    • the concentration of GDF-15
  • Postoperative complications
    • Time Frame: 30 days
    • Measured with Clavien Dindo classification (grade I-V where grade V is death)
  • readmission
    • Time Frame: 30 days after surgery
    • Number of patients being readmitted to hospital within 30 days after operation for colon surgery.
  • survival
    • Time Frame: 10 years
    • number of survivors after surgery
  • mortality
    • Time Frame: baseline to 3 months
    • number of patients death
  • number of patients to start up of adjuvant chemotherapy after surgery.
    • Time Frame: 14 weeks
    • according to guidelines, if physical condition allows it (and patient accepts it).
  • start up time of adjuvant chemotherapy after surgery
    • Time Frame: 14 weeks
    • measured in days (if relevant)
  • number of series of adjuvant chemotherapy
    • Time Frame: 14 weeks
  • doses of adjuvant chemotherapy
    • Time Frame: 14 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • elective surgery for coloncancer
  • 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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Herlev and Gentofte Hospital
  • Collaborator
    • Velux Fonden
  • Provider of Information About this Clinical Study
    • Principal Investigator: Troels Gammeltoft Dolin, MD, Principal Investigator, Department of internal Medicine – Herlev and Gentofte Hospital
  • Overall Official(s)
    • Julia S Johansen, MD, PhD, Study Chair, Professor
  • Overall Contact(s)
    • Troels G Dolin, MD, +45 26332809, troels.gammeltoft.dolin@regionh.dk

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