The aim is to investigate the effect of a multimodal prehabilitation and rehabilitation program in frail patients of 70 years or older, undergoing elective surgery for non-metastatic CRC on1. One-year mortality 2. Postoperative complications,…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline characteristics, information about the prehabilitation and
rehabilitation program will be prospectively collected from the medical
records. Patients demographics, tumour and treatment characteristics and
postoperative complications, will be prospectively collected through the
nationwide obligatory data collection of Dutch ColoRectal Audit (DCRA).
Information about one year mortality, functional status and quality of live
outcomes, are obtained through the Triage of Elderly Needing Treatment (TENT)
study.
Secondary outcome
Not applicable
Background summary
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 objective
The aim is to investigate the effect of a multimodal prehabilitation and
rehabilitation program in frail patients of 70 years or older, undergoing
elective surgery for non-metastatic CRC on
1. One-year mortality
2. Postoperative complications, surgical and non-surgical complications
3. Functional capacity, quality of life (QoL)
4. Physical performance, nutritional status and cognitive status
Study design
A multicentre prospective experimental cohort study implemented by a stepped
wedge design.
Intervention
Patients are included in the control group or in the prehabilitation and
rehabilitation (intervention) group according to a stepped wedge design. In
addition to standard care, all patients in the intervention group will
preoperatively undergo a multimodal program, including a four to six weeks
exercise program including strength and endurance training, diet advice and
nutritional support, psychosocial support, smoking cessation and additional
medical optimization, e.g. iron infusion for iron deficiency anaemia.
Postoperatively, patients will start postoperative rehabilitation, including
minimally four weeks exercise program and nutritional monitoring.
Study burden and risks
The prehabilitation and rehabilitation program might be demanding, because of
the exercise program and the fact that patients need to visit the hospital more
frequently. Therefore patients might be at risk for overuse complaints, as
fatigue or muscle or joint pain.
The prehabilitation period consists of at least two appointments at the
clinical physiotherapist (30-45min), an appointment at the dietician (45min), a
nutritional evaluation by telephone (15 min), an exercise program of 4-6 weeks
(2-3x p week) and when necessary, patients may receive psychologic support,
smoking cessation and iron infusion. If iron infusion is indicated, it will be
performed under supervision and a patient will stay at least 30 minutes in the
hospital after the infusion has stopped to monitor potential allergic reaction.
An allergic reaction is rare (0.01-0.1%).
In the rehabilitation period, patients need to perform an exercise program of
at least 4 weeks and have nutritional evaluation by telephone. In the follow-up
patients need to perform physical and cognitive tests at 3, 6 and 12 months and
if indicated patients will be monitored by the dietician by telephone or by
hospital visits. As part of the TENT study patients will be contacted to
provide information about QoL, ADL and IADL at 6 and 12 months.
Reinier de Graafweg 5
Delft 2625 AD
NL
Reinier de Graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
- diagnosed with colorectal cancer at the age >= 70 years
- no metastatic disease
- planned for elective surgery
- positive geriatric screening based on the G8 or 6CIT
Exclusion criteria
- potential need for surgery in semi-acute of urgent setting due to medical
reasons, e.g. obstructive tumour complaints, faecal incontinence etc.
- eventually no need for surgery due to complete tumour remission after
chemo-radiation in rectal cancer patients
- not willing to provide informed consent for the current study
- not willing to provide informed consent for the TENT study
- not able to provide informed consent
- not able to perform an exercise program; for instance wheelchair-dependent
patients or paraplegic patients
- patients in whom 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
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL72163.058.19 |
Other | NL8107 |