No registrations found.
ID
Source
Brief title
Health condition
Coloncancer or rectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
One-year survival
Secondary outcome
Rate of postoperative complications, quality of life and functional capacity (ADL)
Background summary
In this study, we will identify frailty in older colorectal cancer patients on six domains: physical performance, nutritional status, anemia, psychosocial, cognitive and smoking status. In case of frailty, patients will start with prehabilitation and rehabilitation to increase the preoperative and postoperative capacity and reduce the impact of surgery.
Study objective
As the incidence of colorectal cancer (CRC) is increasing with age and several surgical developments have been made the past few years, the number of older patients receiving surgical treatment is increasing. However, the impact of surgery should not be underestimated in the older CRC patients. Especially the frail older CRC patients have higher
mortality and postoperative complication rates in comparison to the non-frail patients. Identifying and modifying vulnerabilities before and after surgery may increase the capacity and decrease the impact of surgery. Evidence of prehabilitation with or without the combination of rehabilitation is limited and inconsistent due to studies with small
sample sizes and the inclusion of non-frail patients. This means that a large cohort study is needed to establish the effect of prehabilitation and rehabilitation in frail older CRC patients.
Study design
Inclusion, baseline measurements, preoperative frailty evaluation, postoperative physcial test at 3, 6 and 12 months , postoperative evaluation of Qol and ADL at 6 and 12 months.
Intervention
Included patients will be screened for frailty on physical performance, nutritional status, anaemia, psychosocial, cognitive and smoking status. The physiotherapist will screen for physical frailty, the dietician for nutritional fraitly, the geriatrician for cognitive and psychosocial frailty and the surgeon for anaemia and smoking status. Only in case of frailty - defined by clear cut off points- interventions are initiated. Potential interventions are: four — six week exercise program, protein or energy supplements, iron infusion in case of proven iron deficiency anaemia, delirium preventing strategies, psychologic consultation and smoking cessation.
Inclusion criteria
- diagnosis of colorectal cancer
- 70 years or older
- non-metastatic disease
- planned for elective surgery
- positive geriatric screening based on the G8 or 6CIT
Exclusion criteria
- Need for surgery in acute setting
- No need for surgery due to complete tumour remission after chemo-radiation in rectal cancer patients
- Not willing to provide informed consent
- Not able to perform an exercise program; for instance wheelchair-dependent patients or paraplegic patients
- Patients in whom an exercise program is contra-indicated due to severe cardiopulmonary problems, diagnosed by a cardiologist and/or pulmonologist (for example COPD gold IV,unstable coronary artery disease, heart failure or poorly controlled arrhythmias).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8321 |
| CCMO | NL72163.058.19 |
| OMON | NL-OMON52663 |