Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Radboud University Medical Center
- Enrollment
- 72
- Locations
- 5
- Primary Endpoint
- EQ-5D-5L
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.
Detailed Description
This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
- •Scheduled for colorectal cancer surgery
Exclusion Criteria
- •Metastatic disease known preoperatively
- •ASA IV score or higher
- •Paralytic or immobilized patients (not capable to perform exercise)
- •Prior use of neoadjuvant therapy for the same indication
- •Not able or willing to provide written informed consent
Outcomes
Primary Outcomes
EQ-5D-5L
Time Frame: 0-6 months
Quality of life according to the EuroQol-5 dimensions-5 levels questionnaire. The 5 dimensions cover mobility, selfcare, daily activities, pain/discomfort and anxiety. All dimensions are rated on a 5 level scale ranging from 'I have no problems with ....(dimension)' to 'I am not able to/I am extremely...(dimension)'. The first option is considered 'better' and the latter as 'worse'.
Costs
Time Frame: 0-6 months
From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers
Secondary Outcomes
- Number of deceased patients(0-6 months)
- Morbidity(0-6 months)
- (I)ADL dependence by TOPICS-SF(0-6 months)
- (I)ADL dependence by GARS(0-6 months)
- Return to normal activity(0-6 months)
- Care-related burden among informal caregivers(0-6 months)