To determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with HNC or liver cancer
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hoofd-hals kanker en lever kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is feasibility of the prehabilitation program (program
satisfaction, program compliance and percentage of patients willing to
participate in the prehabilitation program)
Secondary outcome
Our secondary outcomes include:
-Physical outcomes (Functional capacity, daily physical acitvity levels, hand
grip strengt, quadriceps strength)
-Nutritional outcomes (nutritional status, body composition)
-Psychosocial outcomes (health status, anxiety and depression, self-efficacy)
-Substance abuse (smoking, alcohol consumption)
-Post operative outcomes (length of hospital stay, complications in first 30
days, readmission rate in first 30 days)
Background summary
In patients diagnosed with head and neck cancer (HNC) or liver cancer, (major)
surgery is the standard of care. Nevertheless, surgery may result in
complications that have a substantial impact on the physical and psychological
state of the patient. Detrimental postoperative outcomes are influenced by
unhealthy lifestyle behaviors such as a sedentary lifestyle, smoking and
malnutrition. Prehabilitation programs focusing on these lifestyle aspects have
been suggested as a promising intervention to improve pre- and postoperative
outcomes.
Study objective
To determine the feasibility (main aim) and effectiveness (secondary aim) of a
prehabilitation program in patients with HNC or liver cancer
Study design
A prospective cohort (pilot) study
Intervention
A 3-to-6-week prehabilitation program consisting of training and nutritional,
smoking cessation and psychosocial counselling.
Study burden and risks
Patients will participate in a prehabilitation program during the 3-to-6-week
period prior to the scheduled surgery. The prehabilitation sessions will last
approximately 3-5 hours per week. To lower the burden for patients, the
majority of the program can be delivered in the home situation using digital
tools. Only the intake during the first week (60 min duration) has to be
performed on site (Erasmus MC). Furthermore, patients are expected in the
Erasmus MC at the start and after completion of the prehabilitation program to
undergo measurements (90 min) and complete questionnaires at home (two times 20
min, one time 10 min). Lastly, patients are asked to wear an accelerometer
around their waist at two time points during the prehabilitation period (first
week and final week). Despite that the accelerometer is small, wearing it might
be experienced as a burden.
Since the prehabilitation program is based on existing care, we expect minimal
risks for the participants. Patients are anticipated to benefit from the pilot
prehabilitation program considering a behavioral change towards a healthier
lifestyle leading to increased fitness, health, quality of life and less
complications post-surgery. Since this is uncertain, we do not know yet whether
the prehabilitation program is actually effective.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients with a diagnosis of head and neck cancer or liver cancer that are
scheduled for surgery in Erasmus MC.
Exclusion criteria
1) Patients that do not understand the Dutch language
2) Patients with severe physical or psychological comorbidities that limit
participation in the prehabilitation program
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80823.078.22 |