PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
- Conditions
- Cancer LiverCancer Head Neck
- Interventions
- Behavioral: Prehabilitation
- Registration Number
- NCT05745558
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
The objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
- Detailed Description
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. Therefore, the obective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with HNC or liver cancer
This study concerns a prospective cohort study in 60 patients with HNC or liver cancer that participate in a 3 to 6-week pilot prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
Data on feasibility (program satisfaction, program compliance and percentage of patients willing to participate in the prehabilitation program) and effectiveness (e.g. complications, health status, compliance to healthy lifestyle) is collected at three time points (pre- and post the prehabilitation program and 30 days post-surgery).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age ≥18 years
- Diagnosis of head and neck cancer or liver cancer
- Scheduled for surgery in Erasmus MC
- Provision of written informed consent
- Only patient with a waiting time of at least 3 weeks till surgery can participate in this study
- Patients that do not understand the Dutch language
- Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
- Primary Outcome Measures
Name Time Method Percentage of patients willing to participate in prehabilitation program At completion of the prehabilitation program (3-6 weeks after baseline) It will be registered which patient are willing and not willing to participate
Program satisfaction At completion of the prehabilitation program (3-6 weeks after baseline) Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance At completion of the prehabilitation program (3-6 weeks after baseline) Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
- Secondary Outcome Measures
Name Time Method Age Baseline Age in years
Functional capacity At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) 6-minute walk test: meters walked in 6 minutes time
Smoking behaviour At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) carbon monoxide breath analyser (CO ppm + % COhb)
Work status Baseline Single-item question (employed/unemployed)
Frailty Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Groningen Frailty Score questionnaire score: score of 0-15, a GFI score of four or greater is considered the cut-off point for frailty
Physical activity level At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour
Body composition At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Weight scale (kg)
Alcohol consumptiom At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse)
Educational level Baseline Single-item question (high, middle, low educated)
Nutritional status At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition)
Length of hospital stay 30 days post surgery Registrered in patient file (length in days)
Hand grip strength At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Hand dynamometer (kg)
Quadriceps strength At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Biodex dynamometer (Peak torque to body weight extension + Work fatigue)
Anxiety and Depression At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression
Self-efficacy At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy
Self-reported smoking behaviour At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) Self-designed questionnaire (smoking yes/no)
Readmission rate in first 30 days 30 days post surgery Number and reason for readmissions in first 30 days
Health status At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state)
Complications Clavien Dindo grade ≥3 in first 30 days 30 days post surgery Registrered in patient file (number of complications and clavien dindo grade)
Sex Baseline Female/male/other
Medical diagnosis Baseline Medical diagnosis for surgery
Marital status Baseline Single-item question (Partnered/ unpartnered)
Trial Locations
- Locations (1)
ErasmusMC
🇳🇱Rotterdam, South Holland, Netherlands