PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)

Study Overview
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Brief Summary
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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
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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).

Official Title
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PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)

Conditions
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Cancer Liver, Cancer Head Neck

Intervention / Treatment
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* Behavioral: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients that do not understand the Dutch language Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling. | Behavioral: Prehabilitation<br>* The prehabilitation program consists of 4 components: Fitness training led by a physiotherapist. The patients will receive personalized training schedules to perform at home. The training sessions focus on improving aerobic fitness (biking or walking) and muscle strength (specific exercises for the different patient groups) and respiratory exercises aimed to relax. Nutritional counseling led by a dietician. All patients will be offered an intake with a dietician (60 min) to discuss current eating habits and give personalized advices. Based on indication, patients will receive follow-up consults. Smoking cessation counseling led by a trained social worker. For patients that are currently smoking, a social worker will offer counseling sessions to coach the patient in the process of smoking cessation. Psychosocial counseling led by a psychologist. All patients will be offered counselling by a psychologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program satisfaction | Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction) | At completion of the prehabilitation program (3-6 weeks after baseline) | 
| Program compliance | Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered. | At completion of the prehabilitation program (3-6 weeks after baseline) | 
| Percentage of patients willing to participate in prehabilitation program | It will be registered which patient are willing and not willing to participate | At completion of the prehabilitation program (3-6 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty | Groningen Frailty Score questionnaire score: score of 0-15, a GFI score of four or greater is considered the cut-off point for frailty | Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Functional capacity | 6-minute walk test: meters walked in 6 minutes time | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Physical activity level | ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Hand grip strength | Hand dynamometer (kg) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Quadriceps strength | Biodex dynamometer (Peak torque to body weight extension + Work fatigue) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Nutritional status | Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Body composition | Weight scale (kg) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Health status | EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state) | At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery | 
| Anxiety and Depression | Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Self-efficacy | General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Self-reported smoking behaviour | Self-designed questionnaire (smoking yes/no) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Smoking behaviour | carbon monoxide breath analyser (CO ppm + % COhb) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Alcohol consumptiom | Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | 
| Length of hospital stay | Registrered in patient file (length in days) | 30 days post surgery | 
| Complications Clavien Dindo grade ≥3 in first 30 days | Registrered in patient file (number of complications and clavien dindo grade) | 30 days post surgery | 
| Readmission rate in first 30 days | Number and reason for readmissions in first 30 days | 30 days post surgery | 
| Age | Age in years | Baseline | 
| Sex | Female/male/other | Baseline | 
| Medical diagnosis | Medical diagnosis for surgery | Baseline | 
| Educational level | Single-item question (high, middle, low educated) | Baseline | 
| Marital status | Single-item question (Partnered/ unpartnered) | Baseline | 
| Work status | Single-item question (employed/unemployed) | Baseline |