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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
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.
Herlev and Gentofte Hospital
Herlev, Region H, Denmark
30-second chair stand test (30s-CST)
functional test measuring lower body strength
Time frame: baseline to 14 weeks after surgery
physical function and capacity - 6-minute-walk-test
6-minute-walk-test
Time frame: baseline to 14 weeks after surgery
physical function and capacity - hand grip strength
hand grip strength
Time frame: baseline to 14 weeks after surgery
physical function and capacity - 6-meter gait speed
6-meter gait speed
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 day before surgery (baseline) to 3 days after surgery
body composition
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measured by Bioimpedance assessment
Time frame: baseline to 14 weeks after surgery.
body composition
measured by dual-energy x-ray absorptiometry
Time frame: baseline to 14 weeks after surgery.
inflammatory biomarker - CRP
the concentration of CRP (CRP C-reactive Protein)
Time frame: baseline to 14 weeks after surgery
inflammatory biomarker - Interleukin 6
the concentration of interleukin 6
Time frame: 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)
Time frame: baseline to 14 weeks after surgery
inflammatory biomarkers immuno-oncology
the concentration of 92 proteins associated with immuno-oncology (OLink)
Time frame: baseline to 14 weeks after surgery
sarcopenia biomarker GDF-11
the concentration of GDF-11 (GDF Growth Differentiation Factor)
Time frame: baseline to 14 weeks after surgery
sarcopenia biomarker GDF
the concentration of GDF-15 (GDF Growth Differentiation Factor)
Time frame: baseline to 14 weeks after surgery
Postoperative complications
Measured with Clavien Dindo classification (grade I-V where grade V is death)
Time frame: 30 days + 90 days
readmission
Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.
Time frame: 30 days after surgery and 90 days after surgery
survival
number of survivors after surgery
Time frame: 10 years
mortality
number of patients death
Time frame: 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).
Time frame: 14 weeks
start up time of adjuvant chemotherapy after surgery
measured in days (if relevant)
Time frame: 14 weeks
number of series of adjuvant chemotherapy
Time frame: 14 weeks
doses of adjuvant chemotherapy
Time frame: 14 weeks