Cancer Head Neck Clinical Trial
— PREPAREOfficial title:
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | ErasmusMC | Rotterdam | South Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Capri Hartrevalidatie, Rijndam Revalidatiecentrum |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Hand grip strength | Hand dynamometer (kg) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Body composition | Weight scale (kg) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Self-reported smoking behaviour | Self-designed questionnaire (smoking yes/no) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | |
Secondary | Smoking behaviour | carbon monoxide breath analyser (CO ppm + % COhb) | At baseline and at completion of the prehabilitation program (3-6 weeks after baseline) | |
Secondary | 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) | |
Secondary | Length of hospital stay | Registrered in patient file (length in days) | 30 days post surgery | |
Secondary | Complications Clavien Dindo grade =3 in first 30 days | Registrered in patient file (number of complications and clavien dindo grade) | 30 days post surgery | |
Secondary | Readmission rate in first 30 days | Number and reason for readmissions in first 30 days | 30 days post surgery | |
Secondary | Age | Age in years | Baseline | |
Secondary | Sex | Female/male/other | Baseline | |
Secondary | Medical diagnosis | Medical diagnosis for surgery | Baseline | |
Secondary | Educational level | Single-item question (high, middle, low educated) | Baseline | |
Secondary | Marital status | Single-item question (Partnered/ unpartnered) | Baseline | |
Secondary | Work status | Single-item question (employed/unemployed) | Baseline |
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