Colon Cancer, Colon Neoplasm, Colorectal Cancer, Frail Elderly Syndrome
Conditions
Keywords
Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal
Brief summary
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
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.
Interventions
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.
Sponsors
Velux Fonden
University of Copenhagen
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Physiotherapist assessing function status.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-second chair stand test (30s-CST) | baseline to 14 weeks after surgery | functional test measuring lower body strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical function and capacity - hand grip strength | baseline to 14 weeks after surgery | hand grip strength |
| physical function and capacity - 6-meter gait speed | baseline to 14 weeks after surgery | 6-meter gait speed |
| Patient reported Quality of Life: EORTC | 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 | 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) |
| Quality of recovery after surgery: questionnaire | 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) |
| body composition | baseline to 14 weeks after surgery. | measured by Bioimpedance assessment |
| inflammatory biomarker - CRP | baseline to 14 weeks after surgery | the concentration of CRP (CRP C-reactive Protein) |
| inflammatory biomarker - Interleukin 6 | baseline to 14 weeks after surgery | the concentration of interleukin 6 |
| inflammatory biomarker YKL-40 | baseline to 14 weeks after surgery | the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1) |
| inflammatory biomarkers immuno-oncology | baseline to 14 weeks after surgery | the concentration of 92 proteins associated with immuno-oncology (OLink) |
| physical function and capacity - 6-minute-walk-test | baseline to 14 weeks after surgery | 6-minute-walk-test |
| sarcopenia biomarker GDF | baseline to 14 weeks after surgery | the concentration of GDF-15 (GDF Growth Differentiation Factor) |
| Postoperative complications | 30 days + 90 days | Measured with Clavien Dindo classification (grade I-V where grade V is death) |
| readmission | 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. |
| survival | 10 years | number of survivors after surgery |
| mortality | baseline to 3 months | number of patients death |
| number of patients to start up of adjuvant chemotherapy after surgery. | 14 weeks | according to guidelines, if physical condition allows it (and patient accepts it). |
| start up time of adjuvant chemotherapy after surgery | 14 weeks | measured in days (if relevant) |
| number of series of adjuvant chemotherapy | 14 weeks | — |
| doses of adjuvant chemotherapy | 14 weeks | — |
| sarcopenia biomarker GDF-11 | baseline to 14 weeks after surgery | the concentration of GDF-11 (GDF Growth Differentiation Factor) |
Countries
Denmark
Outcome results
None listed