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NCT Number: NCT03719573

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

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.

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Key information

Conditions

Colon Cancer Behavior Colon Neoplasm Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Frail Elderly Syndrome Frailty Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte Hospital

Herlev, Region H, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric intervention

Other

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 outcomes

  1. 30-second chair stand test (30s-CST)

    Time frame: baseline to 14 weeks after surgery

    functional test measuring lower body strength

Secondary outcomes

  1. physical function and capacity - 6-minute-walk-test

    Time frame: baseline to 14 weeks after surgery

    6-minute-walk-test

  2. physical function and capacity - hand grip strength

    Time frame: baseline to 14 weeks after surgery

    hand grip strength

  3. physical function and capacity - 6-meter gait speed

    Time frame: baseline to 14 weeks after surgery

    6-meter gait speed

  4. 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)

  5. 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 conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)

  6. 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)

  7. body composition

    Time frame: baseline to 14 weeks after surgery.

    measured by Bioimpedance assessment

  8. body composition

    Time frame: baseline to 14 weeks after surgery.

    measured by dual-energy x-ray absorptiometry

  9. inflammatory biomarker - CRP

    Time frame: baseline to 14 weeks after surgery

    the concentration of CRP (CRP C-reactive Protein)

  10. inflammatory biomarker - Interleukin 6

    Time frame: baseline to 14 weeks after surgery

    the concentration of interleukin 6

  11. inflammatory biomarker YKL-40

    Time frame: baseline to 14 weeks after surgery

    the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)

  12. inflammatory biomarkers immuno-oncology

    Time frame: baseline to 14 weeks after surgery

    the concentration of 92 proteins associated with immuno-oncology (OLink)

  13. sarcopenia biomarker GDF-11

    Time frame: baseline to 14 weeks after surgery

    the concentration of GDF-11 (GDF Growth Differentiation Factor)

  14. sarcopenia biomarker GDF

    Time frame: baseline to 14 weeks after surgery

    the concentration of GDF-15 (GDF Growth Differentiation Factor)

  15. Postoperative complications

    Time frame: 30 days + 90 days

    Measured with Clavien Dindo classification (grade I-V where grade V is death)

  16. readmission

    Time frame: 30 days after surgery and 90 days after surgery

    Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.

  17. survival

    Time frame: 10 years

    number of survivors after surgery

  18. mortality

    Time frame: baseline to 3 months

    number of patients death

  19. 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).

  20. start up time of adjuvant chemotherapy after surgery

    Time frame: 14 weeks

    measured in days (if relevant)

  21. number of series of adjuvant chemotherapy

    Time frame: 14 weeks

  22. doses of adjuvant chemotherapy

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • University of Copenhagen
  • Velux Fonden

Registry information

Acronym: GEPOC

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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