Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Overview

This is a randomized, controlled trial on frail elderly patients (aged 65+) 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 perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.

Full Title of Study: “Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer – a Randomized, Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2015

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
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative complications
    • Time Frame: 30 days after surgery

Secondary Measures

  • Reoperation
    • Time Frame: 30 days after surgery
    • Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
  • Readmission
    • Time Frame: 30 days after surgery
    • Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
  • Length of hospital stay
    • Time Frame: 30 days after surgery
  • Survival
    • Time Frame: 3 months after surgery
  • Quality of life
    • Time Frame: 3 months after surgery
  • Living at home or in institution
    • Time Frame: 3 months after surgery
    • Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 65+
  • Elective surgery for colorectal cancer
  • Frail

Exclusion Criteria

  • Acute surgery
  • Not able to consent
  • Does not consent with registration

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Collaborator
    • Norwegian Cancer Society
  • Provider of Information About this Clinical Study
    • Principal Investigator: Torgeir Bruun Wyller, Professor – Oslo University Hospital
  • Overall Official(s)
    • Torgeir B Wyller, Dr.med, Study Chair, Geriatric dept., Oslo University hospital

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