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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer, Colon Neoplasm, Frail Elderly Syndrome, Colorectal Cancer

Intervention / Treatment
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* Other: Geriatric intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geriatric intervention<br>A comprehensive geriatric assessment and intervention, including exercise program. | Other: Geriatric intervention<br>* 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.<br>|
| No Intervention: control.<br>Usual treatment and care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal