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| Name | Class |
|---|---|
| Rijndam Revalidatiecentrum | UNKNOWN |
| Capri Hartrevalidatie | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | The prehabilitation program consists of 4 components:
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nienke ter Hoeve, PhD | Contact | 0031107044599 | n.terhoeve@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ErasmusMC | Recruiting | Rotterdam | South Holland | 3000CA | Netherlands |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Prospective Cohort Study
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|
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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |