Clinical trial NCT03719573: Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
Official title: Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Colon Neoplasm
Frail Elderly Syndrome
Colorectal Cancer
Keywords: Colon Cancer
Frailty
Geriatric assessment
perioperative care
exercise
quality of recovery
colorectal
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: University of Copenhagen
First posted: 2018-10-25
Enrollment: 67
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-second chair stand test (30s-CST)
timeFrame: baseline to 14 weeks after surgery
Secondary outcomes:
measure: physical function and capacity - 6-minute-walk-test
timeFrame: baseline to 14 weeks after surgery
measure: physical function and capacity - hand grip strength
timeFrame: baseline to 14 weeks after surgery
measure: physical function and capacity - 6-meter gait speed
timeFrame: baseline to 14 weeks after surgery
measure: Patient reported Quality of Life: EORTC
timeFrame: baseline to 14 weeks after surgery
measure: Patient reported Quality of Life: EORTC ELD14
timeFrame: baseline to 14 weeks after surgery
measure: Quality of recovery after surgery: questionnaire
timeFrame: 1 day before surgery (baseline) to 3 days after surgery
measure: body composition
timeFrame: baseline to 14 weeks after surgery.
measure: body composition
timeFrame: baseline to 14 weeks after surgery.
measure: inflammatory biomarker - CRP
timeFrame: baseline to 14 weeks after surgery
measure: inflammatory biomarker - Interleukin 6
timeFrame: baseline to 14 weeks after surgery
measure: inflammatory biomarker YKL-40
timeFrame: baseline to 14 weeks after surgery
measure: inflammatory biomarkers immuno-oncology
timeFrame: baseline to 14 weeks after surgery
measure: sarcopenia biomarker GDF-11
timeFrame: baseline to 14 weeks after surgery
measure: sarcopenia biomarker GDF
timeFrame: baseline to 14 weeks after surgery
measure: Postoperative complications
timeFrame: 30 days + 90 days
measure: readmission
timeFrame: 30 days after surgery and 90 days after surgery
measure: survival
timeFrame: 10 years
measure: mortality
timeFrame: baseline to 3 months
measure: number of patients to start up of adjuvant chemotherapy after surgery.
timeFrame: 14 weeks
measure: start up time of adjuvant chemotherapy after surgery
timeFrame: 14 weeks
measure: number of series of adjuvant chemotherapy
timeFrame: 14 weeks
measure: doses of adjuvant chemotherapy
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
state: Region H
Study officials:
affiliation: Professor
name: Julia S Johansen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.