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

Not Applicable

Completed

• Conditions: Frail Elderly Syndrome; Colon Cancer; Colon Neoplasm; Colorectal Cancer
• Interventions: Other: Geriatric intervention

• Registration Number: NCT03719573
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-02-21
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• elective surgery for colorectal cancer
• frail
• ability to read and speak danish (informed concent)

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Exclusion Criteria

• any physical condition that hinder physical exercise (eg. no legs)
• not able to concent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric intervention	Geriatric intervention	A comprehensive geriatric assessment and intervention, including exercise program.

Primary Outcome Measures

Name	Time	Method
30-second chair stand test (30s-CST)	baseline to 14 weeks after surgery	functional test measuring lower body strength

Secondary Outcome Measures

Name	Time	Method
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).
physical function and capacity - hand grip strength	baseline to 14 weeks after surgery	hand grip strength
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)
Postoperative complications	30 days + 90 days	Measured with Clavien Dindo classification (grade I-V where grade V is death)
number of series of adjuvant chemotherapy	14 weeks
physical function and capacity - 6-minute-walk-test	baseline to 14 weeks after surgery	6-minute-walk-test
inflammatory biomarker - CRP	baseline to 14 weeks after surgery	the concentration of CRP (CRP C-reactive Protein)
body composition	baseline to 14 weeks after surgery.	measured by dual-energy x-ray absorptiometry
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-meter gait speed	baseline to 14 weeks after surgery	6-meter gait speed
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)
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)
survival	10 years	number of survivors after surgery
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)
inflammatory biomarker - Interleukin 6	baseline to 14 weeks after surgery	the concentration of interleukin 6
sarcopenia biomarker GDF-11	baseline to 14 weeks after surgery	the concentration of GDF-11 (GDF Growth Differentiation Factor)
sarcopenia biomarker GDF	baseline to 14 weeks after surgery	the concentration of GDF-15 (GDF Growth Differentiation Factor)
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.
mortality	baseline to 3 months	number of patients death
start up time of adjuvant chemotherapy after surgery	14 weeks	measured in days (if relevant)
doses of adjuvant chemotherapy	14 weeks

Trial Locations

Locations (1)

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Region H, Denmark