PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
NCT ID: NCT05745558
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-04-01
2025-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prehabilitation
A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
Prehabilitation
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.
Interventions
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Prehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* 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 with severe physical or psychological comorbidities that limit participation in the prehabilitation program
18 Years
ALL
No
Sponsors
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Rijndam Revalidatiecentrum
UNKNOWN
Capri Hartrevalidatie
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Roeland F. de Wilde
Principal Investigator
Locations
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ErasmusMC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL 80823.078.22
Identifier Type: -
Identifier Source: org_study_id
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