Cancer Head Neck, Cancer Liver
Conditions
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).
Interventions
BEHAVIORALPrehabilitation
The prehabilitation program consists of 4 components: 1. 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. 2. 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. 3. 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. 4. Psychosocial counseling led by a psychologist. All patients will be offered counselling by a psychologist.
Sponsors
Rijndam Revalidatiecentrum
Capri Hartrevalidatie
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective Cohort Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Body composition | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | Weight scale (kg) |
| 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) |
| 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) |
| Smoking behaviour | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | carbon monoxide breath analyser (CO ppm + % COhb) |
| 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 |
| Length of hospital stay | 30 days post surgery | Registrered in patient file (length in days) |
| Complications Clavien Dindo grade ≥3 in first 30 days | 30 days post surgery | Registrered in patient file (number of complications and clavien dindo grade) |
| Readmission rate in first 30 days | 30 days post surgery | Number and reason for readmissions in first 30 days |
| Age | Baseline | Age in years |
| Sex | Baseline | Female/male/other |
| Medical diagnosis | Baseline | Medical diagnosis for surgery |
| Educational level | Baseline | Single-item question (high, middle, low educated) |
| Marital status | Baseline | Single-item question (Partnered/ unpartnered) |
| Work status | Baseline | Single-item question (employed/unemployed) |
| 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) |
| 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 |
| 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 |
Countries
Netherlands
Contacts
Primary ContactNienke ter Hoeve, PhD
Outcome results
None listed