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| Name | Class |
|---|---|
| Velux Fonden | OTHER |
| University of Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric intervention | Experimental | A comprehensive geriatric assessment and intervention, including exercise program. |
|
| control. | No Intervention | Usual treatment and care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-second chair stand test (30s-CST) | functional test measuring lower body strength | baseline to 14 weeks after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia S Johansen, MD, PhD | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Herlev | Region H | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36424269 | Derived | Dolin TG, Mikkelsen MK, Jakobsen HL, Vinther A, Zerahn B, Nielsen DL, Johansen JS, Lund CM, Suetta C. The prevalence of sarcopenia and cachexia in older patients with localized colorectal cancer. J Geriatr Oncol. 2023 Jan;14(1):101402. doi: 10.1016/j.jgo.2022.11.001. Epub 2022 Nov 21. | |
| 33516195 | Derived | Dolin TG, Mikkelsen M, Jakobsen HL, Nordentoft T, Pedersen TS, Vinther A, Zerahn B, Vistisen KK, Suetta C, Nielsen D, Johansen JS, Lund CM. Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial). BMC Geriatr. 2021 Jan 30;21(1):88. doi: 10.1186/s12877-021-02045-9. |
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TBA
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Physiotherapist assessing function status.
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |